Wondzorg bij acute (traumatische en chirurgische) wonden

Initiatief: NVVH Aantal modules: 27

Overige technieken pijnbestrijding

Uitgangsvraag

Zijn niet-farmacologische interventies effectief om wondpijn bij acute wonden te bestrijden?

Aanbeveling

Bespreek de mogelijkheid van het aanvullend toepassen van niet-farmacologische interventies ten behoeve van het reduceren van wondpijn met de patiënt. Denk hierbij aan het gebruik van de smartphone voor het spelen van een spelletje, luisteren naar muziek of het kijken van een filmpje.

Overwegingen

Voor- en nadelen van de interventie en de kwaliteit van het bewijs

Er is literatuuronderzoek uitgevoerd naar de effectiviteit van overige technieken om wondpijn te verminderen. Op basis van de geïncludeerde literatuur is er niet met zekerheid te zeggen of overige technieken daadwerkelijk helpen om wondpijn te verminderen.

 

De werkgroep heeft als uitgangspunt genomen dat verbale afleiding standaard wordt gegeven aan een patiënt. Uit de praktijk blijkt dat goede uitleg aan de patiënt, maar ook afleiding middels een gesprek tijdens de wondzorg de mate van pijn(beleving) en angst kunnen verminderen.

 

Mogelijk kunnen overige technieken zoals virtual reality, of afleiding door middel van het spelen van videogames ook helpen bij het verminderen van de pijn tijdens wondzorg. Overige technieken kunnen mogelijk ook een positieve bijdrage leveren op het verminderen van de pijn direct na de wondzorg. Dit werd met name gezien voor virtual reality en audiovisuele afleiding ten tijde van de verbandwissel en niet zozeer voor afleiding door middel van het luisteren van muziek, het spelen van een videospelletje of door middel van een lolly. Alle gerapporteerde niet farmacologische interventies lijken geen effect te hebben op het verminderen van angst bij de wondzorg. Dit is echter alleen bij kinderen onderzocht. De overall bewijskracht van zowel de cruciale uitkomstmaten (pijn tijdens wondzorg en pijn na wondzorg) als de belangrijke uitkomstmaat (angst) is laag. Dit komt voornamelijk doordat de trials een klein aantal patiënten includeerden en doordat blindering niet mogelijk was. Er ligt hier een kennislacune.

 

De hierboven beschreven technieken hebben één ding gemeen, namelijk afleiding. Men zou dus kunnen stellen dat alle manieren om patiënten af te leiden tijdens de wondzorg ertoe kunnen leiden dat de patiënt minder pijn ervaart.

 

Waarden en voorkeuren van patiënten (en eventueel hun verzorgers)

Patiënten ervaren mogelijk minder pijn gedurende de wondzorg en vlak erna, indien er gebruik wordt gemaakt van niet-farmacologische interventies zoals afleiding met videogames en filmpjes kijken tijdens de wondzorg. Daarnaast kan het voorlichten van patiënten ten aanzien van de te verwachten pijn de pijn verlagen, bijvoorbeeld bij postoperatieve pijn (Gräwe, 2010; NVA, 2003).

 

Kosten (middelenbeslag)

Op basis van de huidige literatuurconclusies is het niet gerechtvaardigd om virtual reality of TENS apparatuur aan te schaffen ten behoeve van het verminderen van wondpijn. Echter, er wordt in de literatuur ook gesproken over afleiding door middel van het luisteren van muziek, het kijken van een film, of het spelen van een spelletje op een mobiele telefoon. Aangezien het merendeel van de patiënten een smartphone tot zijn beschikking heeft is het zeker gerechtvaardigd om dit in te zetten ter bestrijding van wondpijn tijdens de wondzorg. Het ‘baat het niet dan schaadt het niet’ principe is hierop van toepassing. 

 

Aanvaardbaarheid, haalbaarheid en implementatie

Ondanks dat het bewijs vanuit de literatuur niet heel sterk is, kan het gebruik van overige technieken mogelijk toch een positief effect hebben op de pijnbeleving tijdens wondzorg.

 

Een aantal methoden zijn eenvoudig beschikbaar in de alledaagse praktijk, namelijk het gebruik van een smartphone om een spelletje te spelen, film te kijken en/of muziek te luisteren.

 

Uiteraard moeten deze technieken als een aanvulling worden gezien die het gebruik van analgetica kunnen verlagen en niet zozeer als substitutie. De werkgroep zou graag zien dat deze mogelijkheid bij alle patiënten aangeboden wordt.

 

Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies

Ondanks dat het bewijs vanuit de literatuur niet heel sterk is, kan het gebruik van overige technieken mogelijk toch een positief effect hebben op de pijnbeleving tijdens wondzorg. De verschillende overige technieken hebben een ding gemeen, namelijk afleiding.

Onderbouwing

Het doel van pijnbestrijding bij patiënten met acute wonden is het bereiken van een comfortabele en optimale wondgenezing. Patiënten kunnen twee soorten wondgerelateerde pijn ervaren: acute pijn als gevolg van wondverzorging of continue pijn (nociceptieve of neuropathische pijn). In deze module richten we ons specifiek op de pijn gerelateerd aan de wondverzorging. Om het gebruik van analgetica te verminderen, werd een literatuuranalyse uitgevoerd om de mogelijkheid van het gebruik van niet-farmacologische interventies te onderzoeken.

Pain during wound care

Low

GRADE

Non-pharmacological interventions (virtual reality and videogame distraction) may reduce pain during wound care when compared with no non-pharmacological interventions in patients with acute wounds.

 

Non-pharmacological interventions (TENS and lollipop distraction) may result in little to no difference in pain during wound care when compared with no non-pharmacological interventions in patients with acute wounds.

 

Sources: (Ding, 2019; Nilsson, 2013; Hargreaves, 1989)

 

Pain after wound care

Low

GRADE

Non-pharmacological interventions (virtual reality, audiovisual distraction) may reduce pain after wound care when compared with no non-pharmacological interventions in patients with acute wounds.

 

Non-pharmacological interventions (music distraction, videogame or lollipop distraction) may result in little to no difference in pain after wound care when compared with no non-pharmacological interventions in patients with acute wounds.

 

Sources: (Ding, 2019; Ferraz, 2021; Guo, 2014; Ha, 2013; Hargreaves, 1989; Nilsson, 2013

 

Anxiety

Low

GRADE

Non-pharmacological interventions (videogame or lollipop distraction) may result in little to no difference in anxiety during dressing changes when compared with no non-pharmacological interventions in patients with acute wounds.

 

Source: (Nilsson, 2013).

Summary of literature

Description of studies

Ferraz (2021) described a randomized clinical trial that investigated the analgesic effect of music for acute procedural pain during diaphyseal tibial fracture dressing changes. Ferraz (2021) included patients who were 18 to 60 years of age, underwent open diaphyseal tibial fracture surgery (at least 24 hours post-surgery) without other bone fractures who received spinal anesthesia. The study included a total of 70 patients. Patients were randomized in two equally distributed groups. The intervention group (n=35) received a music session in addition to the standard pharmacologic analgesia. The control group (n=35) received standard analgesia only. The study reported the following relevant outcome measure: pain after wound care (measured with Numerical Rating Scale (NRS)). The follow-up was until 15 minutes after the completion of the dressing change.

 

Ding (2019) described a randomized clinical trial that investigated whether immersive virtual reality distraction could decrease pain during postoperative dressing changes. Ding (2019) included patients who were aged over 18 years with postoperative wounds that required daily care and dressing changes. The study included a total of 182 patients. Patients were randomized in two equally distributed groups. The intervention group (n=91) received immersive virtual reality distraction during the dressing change procedure. The control group (n=91) only received the standard dressing change procedure. The study reported the following relevant outcome measures: pain during wound care and pain after wound care (measured with visual analog scale (VAS)). The follow-up was until 5 minutes after the completion of the dressing change.

 

Guo (2014) described a randomized clinical trial that investigated the effect of virtual reality distraction on pain among patients with a hand injury undergoing a dressing change. Guo (2014) included patients who were aged 18 years or older with serious hand injuries, and debridement or suturing within 72 hours of injury. The study included a total of 98 patients. Patients were randomized in two equally distributed groups. The intervention group (n=49) was distracted during the dressing change by using a virtual reality intervention. The control group (n=49) did not receive the virtual reality intervention. The study reported the following relevant outcome measure: pain after wound care (measured with VAS). The follow-up was until 5 minutes after the completion of the dressing change.

 

Nilsson (2013) described a randomized clinical trial that investigated the influence of serious gaming and lollipops on pain, distress, and anxiety in conjunction with a wound care session. Nilssons (2013) included patients aged five to 12 years old who visited a specialized wound care nurse for the first time due to acute wounds from a minor trauma. This occurred approximately two to seven days after their visit on the emergency room, where dressings and/or sutures had been applied. The study included a total of 60 patients. Patients were randomized in three equally distributed groups. The first intervention group (n=20) played a videogame and began to play approximately three to five minutes before the wound care session started and continued to play different game paths throughout the session. The second intervention group (n=20) received a lollipop varied in color and flavor. The children started to lick the lollipops approximately three to five minutes before the wound care and continued to do so throughout the session. The control group (n=20) received standard care without any specific distraction techniques added to the care. The study reported the following relevant outcome measures: pain during wound care and pain after wound care (measured with the colored analogue scale (CAS), an equivalent to the VAS-score and the Face, Legs, Activity, Cry and Consolability (FLACC) score) and anxiety (measured with State-Trait Anxiety Inventory (STAI)). The follow-up was until after completion of the wound dressing (exact time not specified).

 

Ha (2013) described a randomized clinical trial that investigated the effects of audiovisual distraction on pain in children during laceration repair in an emergency room. Ha (2013) included patients aged between three and ten years old with lacerated wounds smaller than five centimeters with damaged skin or subcutaneous tissue only. The study included a total of 84 patients. Patients were randomized in two equally distributed groups. The intervention group (n=42) received audiovisual distraction during laceration repair with a DVD of their own preferred choice. The control group (n=42) did not receive audiovisual distraction during laceration repair. The study reported the following relevant outcome measure: pain after wound care (measured with VAS). The follow-up was until after completion of the wound dressing (exact time not specified).

 

Hargreaves (1989) described a randomized clinical trial that investigated the effects of transcutaneous electrical nerve stimulation (TENS) on incisional pain caused by the procedure of cleaning and packing an abdominal surgical wound. Hargreaves (1989) included patients requiring their abdominal incisions to be cleaned and repacked after surgery. The study included a total of 75 patients. Patients were randomized in three equally distributed groups. The intervention group (n=25) received electrical stimulation delivered by a stimulator with a pulse width of 0.4 milliseconds, a frequency of 100 Hertz, 2,5 centimeters from the incision, at least 15 minutes prior to the dressing and throughout the dressing procedure. The duration of the procedure varied. The placebo-TENS group (n=25) received the exact same routine as the intervention group without the electrical stimulation through the electrodes. The control group (n=25) did not expect to receive TENS, nor did they receive it. The study reported the following relevant outcome measures: pain during wound care and pain after wound care (measured with VAS). The follow-up was until after completion of the wound dressing (exact time not specified).

 

Results

Pain during wound care

Pain during wound care was reported in three studies (Ding, 2019; Hargreaves, 1989; Nilsson, 2013). Since different interventions were assessed in these studies, results are presented separately by intervention.

 

Virtual reality

Ding (2019) compared the pain scores during dressing change with VAS in patients who received immersive virtual reality distraction therapy versus patients who did not receive immersive virtual reality distraction therapy (Ding, 2019). Pain scores were measured at several time points during the first dressing change: 5 minutes, 10 minutes, 15 minutes and 20 minutes (Table 2). The VAS-scores were lower for the group of patients who received virtual reality distraction at all time points. The differences in pain scores were only clinically relevant at 15 minutes during the first dressing change.

 

Table 1 Mean differences in patients receiving virtual reality distraction therapy versus patients who did not receive virtual reality distraction therapy (Ding, 2019)

Time point (minutes)

Virtual reality

Mean (SE)

Control

Mean (SE)

Mean difference (95%CI)

5

6.1 (1.6)

6.9 (1.7)

0.8 (-3.78 to 5.38)

10

6.5 (1.8)

7.8 (1.7)

1.3 (-3.55 to 6.15)

15

5.7 (1.6)

8.3 (1.7)

2.6 (-1.98 to 7.18)

20

5.5 (1.5)

7.3 (1.2)

1.8 (-1.97 to 5.57)

TENS

Hargreaves (1989) compared pain scores (VAS) during wound care in patients who received TENS during dressing procedures versus placebo-TENS and no TENS. The mean (SD) pain score during wound care in the intervention group was 3.2 (2.3), compared with 4.5 (2.5) in the placebo-TENS group and 4.9 (2.4) in the control group, favoring the intervention group. None of the differences between the groups were considered clinically relevant.

 

Videogame distraction

Nilsson (2013) compared self-reported pain scores (CAS) and observational pain scores (FLACC) during dressing procedures in patients who received serious videogame distraction versus patients who did not receive specific distraction. The median (range) self-reported pain score during dressing procedures in the intervention group was 3.5 (range 0 to 6), compared to 4 (range 0 to 10) in the control group. This is not considered as a clinically relevant difference. The median (range) observational pain score during dressing procedures in the intervention group was 2 (range 0 to 10), compared to 4 (range 1 to 9) in the control group. This is considered as a clinically relevant difference.

 

Lollipop distraction

Nilsson (2013) compared self-reported pain scores (CAS) and observational pain scores (FLACC) during dressing procedures in patients who received lollipop distraction versus patients who did not receive lollipop distraction. The median (range) self-reported pain score during dressing procedures in the intervention group was 2.4 (range 0 to 10), compared to 4 (range 0 to 10) in the control group. This is not considered as a clinically relevant difference. The median (range) observation pain score during dressing procedures in the intervention group was 4 (range 0 to 8), compared to 4 (range 1 to 9) in the control group. This is not considered as a clinically relevant difference.

 

Pain after wound care

Pain after wound care was reported in six studies (Ferraz, 2021; Ding, 2019; Guo, 2014; Nilsson, 2013; Ha, 2013; Hargreaves, 1989). Since different interventions were assessed in these studies, results are presented separately by intervention.

 

Virtual reality

Two studies assessed the effectivity of virtual reality on pain after wound care (Ding, 2019; Guo, 2014). Ding (2019) compared the pain scores (VAS) after dressing changes in patients who received immersive virtual reality distraction therapy versus patients who did not receive immersive virtual reality distraction therapy (Ding, 2019). The mean difference (MD) in post dressing change pain scores between the intervention (mean 4.26, SE 1.31) and control group (mean 4.28, SE 1.33) was MD -0.02 (95% CI -0.40 to 0.36) favoring the intervention group. This is not considered as a clinically relevant difference. 

 

Guo (2014) compared the pain scores (VAS) after dressing change in patients who received virtual reality versus patients who did not receive virtual reality. The mean (SD) pain score after dressing change in the intervention group was 2.63 (1.27) after dressing change, compared with 7.64 (3.41) in the control group. The mean difference in the intervention group is MD -5.01 (95% CI -6.03 to -3.99), favoring the intervention group. This is considered as a clinically relevant difference. 

 

Audiovisual distraction

Ha (2013) compared pain scores (VAS and FPRS) after laceration repair in patients who received audiovisual distraction versus patients who did not receive audiovisual distraction. The mean (SD) VAS sensory pain response reported by primary caregivers after laceration repair in the intervention group was 3.21 (2.54), compared to 5.65 (3.34) in the control group. The mean difference in pain scores after laceration repair between the intervention and control group was MD -2.44 (95% CI -3.71 to -1.17), favoring the intervention group. This is considered as a clinically relevant difference. The mean (SD) FPRS sensory pain response reported by primary caregivers after laceration repair in the intervention group was 2.71 (3.24), compared to 3.76 (3.36) in the control group. The mean difference in pain scores between the intervention and control group was MD -1.05 (95% CI -2.46 to 0.36), favoring the intervention group. This is not considered as a clinically relevant difference.

 

Music distraction

Ferraz (2021) compared pain scores (NRS) after wound care in patients who received music distraction during standard analgesia versus no music distraction during standard analgesia. The mean (SD) pain score after wound care in the intervention group was 3.4 (2.8), compared with 4.7 (3.3) in the control group. The mean difference in the intervention group was MD -1.30 (95% CI -2.73 to 0.13), favoring the intervention group. This is not considered as a clinically relevant difference.

 

Videogame distraction

Nilsson (2013) compared self-reported pain scores (CAS) and observational pain scores (FLACC) after dressing procedures in patients who received serious videogame distraction versus patients who did not receive specific distraction. The median (range) self-reported pain score (CAS) after dressing procedures in the intervention group was 0 (range 0 to 3.5), compared to 0 (range 0 to 7.25) in the control group. The median (range) observational pain score (FLACC) after dressing procedures in the intervention group was 0 (range 0 to 1), compared to 0 (range 0 to 1) in the control group. This means there was no difference between the two groups for both pain scores.

 

Lollipop distraction

Nilsson (2013) compared self-reported pain scores (CAS) and observational pain scores (FLACC) after dressing procedures in patients who received lollipop distraction versus patients who did not receive lollipop distraction. The median (range) self-reported pain score (CAS) after dressing procedures in the intervention group was 0.375 (range 0 to 4.5), compared to 0 (range 0 to 7.25) in the control group. This is not considered as a clinically relevant difference. The median (range) observed pain score (FLACC) after dressing procedures in the intervention group was 0 (range 0 to 2), compared to 0 (range 0 to 1). This means there was no difference between the two groups.

 

Anxiety

Anxiety was reported in one study (Nilsson, 2013).

 

Videogame distraction

Nilsson (2013) compared anxiety scores (Short STAI) before and after dressing procedures in patients who received serious videogame distraction versus patients who did not receive specific distraction. The median (range) anxiety score before dressing procedures in the intervention group was 10.5 (range 6 to 18), compared to 9 (range 6 to 13) in the control group. The median (range) anxiety score after dressing procedures in the intervention group was 7.5 (range 6 to 15), compared to 6.5 (range 6 to 10) in the control group. This is not considered as a clinically relevant difference.

 

Lollipop distraction

Nilsson (2013) compared anxiety scores (Short STAII) before and after dressing procedures in patients who received lollipop distraction versus patients who did not receive specific distraction. The median (range) anxiety score before dressing procedures in the intervention group was 10 (range 6 to 17), compared to 9 (range 6 to 13) in the control group. The median (range) anxiety score after dressing procedures in the intervention group was 8 (range 6 to 15), compared to 6.5 (range 6 to 10) in the control group. This is not considered as a clinically relevant difference.

 

Level of evidence of the literature

Pain during wound care, pain after wound care, and anxiety

The level of evidence regarding the outcome measure pain comes from a randomised clinical trial and therefore starts high. The level of evidence was downgraded by two levels because of the lack of blinding and the subjective character of pain/anxiety scores (risk of bias, -1), the small number of included patients, and the confidence interval exceeds the values of clinical relevance (imprecision, -1). The level of evidence is low.

Search and select

A systematic review of the literature was performed to answer the following question:

Are non-pharmacological interventions effective in controlling wound pain in patients with acute wounds compared with no non-pharmacological treatment or placebo?

 

P:       patients with acute wounds (traumatic and surgical);

I:       non-pharmacological intervention;

C:       no non-pharmacological intervention / placebo;

O:      pain during wound care, pain after wound care, and anxiety.

 

Relevant outcome measures

The guideline development group considered pain during wound care and pain after wound care as a critical outcome measure for decision making and anxiety as an important outcome measure for decision making.

 

Table 1 shows the definition of the outcome measures, including the clinically relevant differences.

 

Table 1. Clinically relevant differences

Outcome measure

Definition

measurement instrument

Clinically relevant differences

Pain

During and after wound care

VAS, NRS, VRS, COMFORT/FLACC

≥ 2 points

Anxiety

During wound care

STAI

≥ 2 points

When studies reported VAS scores in mm (0 to 100), we presented the scores in cm (0 to 10) to be able to compare study results. 

 

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until 5 March 2021. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 702 hits. Studies were selected based on the following criteria: systematic reviews and randomized clinical about non-pharmacological interventions in the treatment of wound pain. Twenty-four studies were initially selected based on title and abstract screening. After reading the full text, 17 studies were excluded (see the table with reasons for exclusion under the tab Methods) and six studies were included.

 

Results

Six studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.

  1. Ding, J., He, Y., Chen, L., Zhu, B., Cai, Q., Chen, K., & Liu, G. (2019). Virtual reality distraction decreases pain during daily dressing changes following haemorrhoid surgery. The Journal of international medical research, 47(9), 4380–4388. https://doi.org/10.1177/0300060519857862.
  2. Ferraz, MCL, Santana‐Santos, E, Pinto, JS, et al. Analgesic effect of music during wound care among patients with diaphyseal tibial fractures: Randomized controlled trial. Eur J Pain. 2021; 25: 541– 549. https://doi.org/10.1002/ejp.1692.
  3. Guo C, Deng H, Yang J. Effect of virtual reality distraction on pain among patients with hand injury undergoing dressing change. J Clin Nurs. 2015 Jan;24(1-2):115-20. doi: 10.1111/jocn.12626. Epub 2014 Jun 4. PMID: 24899241.
  4. Ha YO, Kim HS. The effects of audiovisual distraction on children's pain during laceration repair. Int J Nurs Pract. 2013 Sep;19 Suppl 3:20-7. doi: 10.1111/ijn.12165. PMID: 24090294.
  5. Hargreaves A, Lander J. Use of transcutaneous electrical nerve stimulation for postoperative pain. Nurs Res. 1989 May-Jun;38(3):159-61. PMID: 2785684.
  6. Nilsson S, Enskär K, Hallqvist C, Kokinsky E. Active and passive distraction in children undergoing wound dressings. J Pediatr Nurs. 2013 Apr;28(2):158-66. doi: 10.1016/j.pedn.2012.06.003. Epub 2012 Jul 20. PMID: 22819747.

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison/ control (C) 3

Follow-up

Outcome measures and effect size 4

Comments

Ferraz, 2021

Type of study:

Randomized, controlled, blinded, clinical trial

 

Setting and country:

Post-anesthetic recovery room, and post-surgical unit of a large public hospital in the North-eastern region of Brazil.

 

Funding and conflicts of interest:

Not reported.

Inclusion criteria:

- 18-60 years;

- Patients in postoperative period of open diaphyseal tibial fracture surgery;

- Patients who receive spinal anesthesia.

 

Exclusion criteria:

- Patients with central nervous system depressant medications used for 12 hours;

- Patients with reported allergy to the institution's standard analgesia;

- Patients with a history of chronic pain;

- Patients with impaired verbal communication;

- Patients with altered auditory acuity;

- Patients who dislike music or patients for whom music did not elicit good sensations;

- Patients who used another non-pharmacological method for pain relief;

- Patients who could not understand the pain assessment instrument.

 

N total at baseline: N=70

Intervention: N= 35

Control: N=35

 

Important prognostic factors2:

n/N (%)

 

20-29 years:

I: 15/35 (42.9%)

C: 9/35 (25.7%)

Total: 24/70 (34.4%)

 

30-39 years:

I: 7/35 (20%)

C: 12/35 (34.3%)

Total: 19/70 (27.1%)

 

40-49 years:

I: 9/35 (25.7%)

C: 11/35 (31.4%)

Total: 20/70 (28.6%)

 

50-59 years:

I: 4/35 (11.4%)

C: 3/35 (8.6%)

Total: 7/70 (10%)

 

Overall p-value = 0.375

 

Sex:

I: 33/35 (94.3%) M

C: 31/35 (88.6%) M

P=0.673

 

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

 

A music session in addition to the standard pharmacologic analgesia

 

 

Describe  control (treatment/procedure/test):

 

Standard pharmacologic analgesia;

Length of follow-up:

-

 

Loss-to-follow-up:

None.

 

Incomplete outcome data:

None.

 

 

Pain intensity

 

Before wound care, n/N (%)

 

No pain (VAS 0)

I: 9/35 (25.7%)

C: 7/35 (20%)

Total: 16/70 (22.9%)

 

Mild pain (VAS 1-3)
I: 10/35 (28.6%)

C: 7/35 (20%)

Total: 17/70 (24.3%)

 

Moderate (VAS 4-6)

I: 12/35 (34.3%)

C: 13/35 (37.1%)

Total: 25/70 (35.7%)

 

Severe pain (VAS 7-10)

I: 4/35 (11.4%)

C: 8/35 (22.9%)

Total: 12/70 (17.1%)

 

After wound care

 

No pain (VAS 0)

I: 12/35 (24.3%)

C: 1/35 (2.9%)

Total: 13/70 (18.6%)

 

Mild pain (VAS 1-3)
I: 16/35 (45.7%)

C: 7/35 (20%)

Total: 23/70 (32.8%)

 

Moderate (VAS 4-6)

I: 7/35 (20%)

C: 13/35 (37.1%)

Total: 20/70 (37.1%)

 

Severe pain (VAS 7-10)

I: 0/35 (0%)

C: 14/35 (40%)

Total: 14/70 (20%)

 

Analgesic effect size of music, mean (SD)

 

Before wound care

I: 3.4 (2.8)

C: 4.7 (3.3)

P=0.099 (R*=0.227)

 

After wound care

I: 2.4 (2.4)

C: 5.8 (2.7)

P<0.001 (R*=0.654)

 

Before versus after

I: R*=0.898

C: R*=0.214

 

 

*=Correlation Rank Biserial

**=F test for Aligned Rank Transformed ANOVA with repeated measures.

Authors conclusion:

 

The results of this blinded, randomized control trial demonstrate that the self-selected music is an effective adjunctive method for relieving pain during the first postoperative dressing change for tibial surgery. The association of pharmacological analgesia with 30 minutes of self-selected music was more effective in reducing pain scores than the use of standard pharmacological analgesia alone. Further prospective RCTs are needed to evaluate the impact of multimodal analgesia using self-select music on additional outcomes, such as analgesic consumption, anxiety, patients’ satisfaction, and duration of hospital stay.

 

Ding, 2019

Type of study:

Prospective, open-label, randomized study

 

Setting and country:

Three hospitals, respectively Huiqiao Medical Centre, Southern Hospital of Southern Medical University, Guangzhou, Guangdong Province, and Department of Health Care, Chines PLA Southern Theatre Command General Hospital, Guangzhou, Guangdon Province China, and Dialysis Centre, York Central Hospital, Richmond Hill, Ontario, Canada.

 

Conflicts of interest:

The authors declare that there are no conflicts of interest.

 

Funding:

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Inclusion criteria:

- aged over 18 years;

- able to communicate clearly without hearing impairment;

- chinese speaking and reading/writing ability;

- an expected hospital stay >7 days;

- with postoperative wounds that required daily care and dressing changes.

 

Exclusion criteria:

- Patients with acute or chronic psychiatric illness;

- critical conditions requiring intensive care;

- physical impairments that precluded the use of VR sets;

- previous VR distraction therapy;

- a history of seizure disorders;

- drug addiction;

- abuse

 

N total at baseline: N=182

Intervention: N=91

Control: N=91

 

Important prognostic factors2:

Age Mean (SD):

I: 46.3 (11.8)

C: 45.2 (12.6)

 

Sex, n/N (%):

I: 34/91 (37.4%) M

C: 38/91 (41.8%) M

 

VAS pain scores prior to dressing change at 0 minutes, mean (SD):

I: 4.09 (1.42)

C: 4.17 (1.31)

 

Groups comparable at baseline? Yes

 

Describe intervention (treatment/procedure/test):

 

Immersive Virtual Reality (IVR) distraction therapy

 

 

Describe  control (treatment/procedure/test):

 

No immersive Virtual Reality (IVR) distraction therapy

Length of follow-up:

-

 

Loss-to-follow-up:

None

 

Incomplete outcome data:

None

 

 

Pain intensity

 

During dressing changes

Not specified: During dressing changes, the mean  SE VAS scores for the VR group were significantly lower than those of the control group at the 5-, 10-, 15- and 20-min time-points (P<0.05 for all comparisons). Repeated measures analysis of variance showed that pain significantly decreased over time in the VR group compared with the control group P < 0.01.

 

Post-dressing change VAS pain scores, mean (SD):

I: 4.26 (1.31)

C: 4.28 (1.33)

 

 

 

 

Guo, 2014

Type of study:

Randomized controlled trial.

 

Setting and country:

Outpatient surgical treatment facility, China.

 

Funding and conflicts of interest:

Not reported.

Inclusion criteria:

- serious hand injuries, including hand skin avulsion, soft tissue defects, damage to the nail bed, fingers, hands etc. caused by crush injuries or firearm injuries;

- debridement or suturing within 72 hours of injury;

- age ≥18 years old;

- male or female;

- the ability to complete the scale and volunteer for the research.

 

Exclusion criteria:

- used analgesics or required the use of other analgesic interventions within 72 hours after injury;

- fewer than three dressing changes;

- visual acuity <1.0;

- hearing disorders;

- cognitive ability <8 points (AMT).

 

N total at baseline: N=98

Intervention: N=49

Control: N=49

 

Important prognostic factors2:

Age, mean (SD):

I: 30.13 (19.54)

C: 32.05 (17.43)

P=0.136

 

Sex, n/N (%):

I: 45/49 (91.8%) M

C: 40/49 (81.6%) M

P=0.325

 

Wound types

Soft tissue defect, N

I: N=7

C: N=5

 

Cuts, N

I: N=11

C: N=10

 

Skin avulsion, N

I: N=13

C: N=14

 

Nail bed, finger, and hand damage, N

I: N=18

C: N=20

 

Anxiety levels (score), mean (SD):

I: 39.67 (9.25)

C: 40.29 (10.27)

P=0.648

 

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

 

Virtual reality

 

 

Describe  control (treatment/procedure/test):

 

No virtual reality

 

Length of follow-up:

-

 

Loss-to-follow-up:

None.

 

Incomplete outcome data:

None.

 

 

Pain intensity

 

VAS-score before versus after dressing within groups, mean (SD):

I: 6.52 (2.17) versus 2.63 (1.27)

P=0.000

 

C: 6.49 (3.12) versus 7.64 (3.41)

P=0.000

 

VAS-score before dressing between groups, mean (SD):

I: 6.52 (2.17)

C: 6.39 (3.12)

P=0.845

 

VAS-score after dressing between groups, mean (SD):

I: 2.63 (1.27)

C: 7.64 (3.41)

P=0.000

 

Author’s conclusion:

 

Virtual reality distraction can effectively alleviate pain among patients with a hand injury undergoing a dressing change. Better pain relief can be obtained by increasing the sense of involvement in the virtual environment.

 

Nilsson, 2013

Type of study:

Non-blinded randomized clinical trial

 

Setting and country:

Large urban centre; paediatric day care unit at the Queen Silvia Children’s Hospital, Gothenburg, Sweden.

 

Funding:

Not reported.

 

Conflicts of interest:

None of the authors have any conflicts.

 

Inclusion criteria:

- Children aged 5 to 12;

- Acute wounds due to a minor trauma.

 

Exclusion criteria:

- Children with long-standing wounds;

Care-related pressure wounds;

Wounds in body areas with decreased sensitivity.

 

N total at baseline: N=60

Intervention1: N=20

Intervention2: N=20

Control: N=20

 

Important prognostic factors2:

Age median:

I1: 8 years

I2: 7 years

C: 7 years

 

Sex, n/N (%):

I: 15/20 (75%) M

I2: 15/20 (75%) M

C: 12/20 (60%) M

 

Type of minor trauma:

Bicycle accident (body/head/limbs), N:

I1: N=1

I2: N=3

C: N=8*

 

Been pinched in fingers/thumbs, N:

I1: N=3

I2: N=6

C: N=4

 

Burns, N:

I1: N=7**

I2: N=5***

C: N=0

 

Fall over, N:

I1: N=5

I2: N=3

C: N=6

 

Postoperative stitches, N:

I1: N=1

I2: N=1

C: N=1

 

Dog bite, N:

I1: N=2

I2: N=0

C: N=0

 

Other minor traumas, N:

I1: N=1

I2: N=2

C: N=1

 

*=p<0.05 between control and serious game intervention

**=p<0.05 between lollipop intervention and control.

***=p<0.05 between serious game intervention and control

 

Groups comparable at baseline? Yes except for 8, **, *** as described above.

 

Describe intervention (treatment/procedure/test):

 

Intervention 1 (I1): Serious video game distraction added to standard of care

 

Intervention 2: (I2): Lollipop distraction during procedure added to standard of care.

 

 

Describe  control (treatment/procedure/test):

 

standard of care without any specific distraction techniques added to the care

Length of follow-up:

-

 

Loss-to-follow-up:

None.

 

Incomplete outcome data:

None.

 

 

Pain intensity

 

Face, Legs, Activity, Cry, and Consolability (FLACC)

Observational pain scores (FLACC) before dressing procedures, median (range):

I1: 0 (0 to 4)

I2: 0 (0 to 2)

C: 0 (0 to 2)

Serious game/control: p=0.643

Lollipop/control: p=0.453

Serious games/lollipop: p=0.809

 

Observational pain scores (FLACC) during dressing procedures, median (range):

I1: 2 (0 to 10)

I2: 4 (0 to 8)

C: 4 (1 to 9)

Serious game/control: p=0.007*

Lollipop/control: p=0.783

Serious games/lollipop: p=0.006*

 

Observational pain scores

(FLACC) after dressing procedures, median (range):

I1: 0 (0 to 1)

I2: 0 (0 to 2)

C: 0 (0 to 1)

Serious game/control: p=0.553

Lollipop/control: p=0.287

Serious games/lollipop: p=0.604

 

Observational pain scores of the individual differences between before, during and after the procedure dressing procedures, median (range):

FLACC

Before-during:

I1: -2 (-7 to 0)**

I2: -4 (-8 to 1)**

C: -4 (-8 to -1)**

Serious game/control: p=0.002***

Lollipop/control: p=0.710

Serious games/lollipop: p=0.004***

 

During-after:
I1: 2 (0 to 10)**

I2: 4 (0 to 8)**
C: 4 (1 to 8)**

Serious game/control: p=0.004***

Lollipop/control: p=0.499

Serious games/lollipop: p=0.008***

 

Coloured Analogue Scale (CAS)

Self-reported pain scores (CAS) before dressing procedures, median (range):

I1: 0 (0 to 6)

I2: 0 (0 to 2)

C: 0 (0 to 4)

Serious game/control: p=0.337

Lollipop/control: p=0.533

Serious games/lollipop: p=0.605

 

Self-reported pain scores (CAS) during dressing procedures, median (range):

I1: 3.5 (0 to 6)

I2: 2.375 (0 to 10)

C: 4 (0 to 10)

Serious game/control: p=0.616

Lollipop/control: p=0.606

Serious games/lollipop: p=0.714

 

Self-reported pain scores (CAS) after dressing procedures, median (range):

I1: 0 (0 to 3.5)

I2: 0.375 (0 to 4.5)

C: 0 (0 to 7.25)

Serious game/control: p=0.546

Lollipop/control: p=0.007

Serious games/lollipop: p=0.258

 

Self-reported pain scores (CAS) before, during and after dressing procedures, median (range):

CAS

Before-during

I1: -2.75 (-5.5 to 2.5)**

I2: -3.25 (-10 to 0)**

C: -2.25 (-10 to 2.25)**

Serious game/control: p=0.849

Lollipop/control: p=0.568

Serious games/lollipop: p=0.322

 

during-after

I1: 2.75 (0 to 5.5)**

I2: 2 (-2 to 10)**

C: 1.875 (-2.25 to 10)**

Serious game/control: p=0.256

Lollipop/control: p=0.675

Serious games/lollipop: p=0.162

 

Anxiety

 

Short State-Trait Anxiety Inventory (Short STAI)

Short STAII scores before dressing procedures, median (range):

I1: 10.5 (6 to 18)

I2: 10 (6 to 17)

C: 9 (6 to 13)

Serious game/control: p=0.165

Lollipop/control: p=0.240

Serious games/lollipop: p=0.622

 

Short State-Trait Anxiety Inventory (Short STAI)

Short STAII scores during dressing procedures, median (range):

Not reported

 

Short State-Trait Anxiety Inventory (Short STAI)

Short STAII scores after dressing procedures, median (range):

I1: 7.5 (6 to 15)

I2: 8 (6 to 15)

C: 6.5 (6 to 10)

Serious game/control: p=0.224

Lollipop/control: p=0.024*

Serious games/lollipop: p=0.223

 

Short State-Trait Anxiety Inventory (Short STAI) before and after dressing procedures, median (range):

Before-after:

I1: 2.5 (-4 to 10)**

I2: 0.5 (-6 to 9)**

C: 1 (-4 to 7)**

Serious game/control: p=0.334

Lollipop/control: p=0.360

Serious games/lollipop: p=0.090

 

 

*P<0.05

**P<0.05 (Wilcoxon signed rank test)

***P<0.05 (Mann-Whitney U test)

Author’s conclusion:

 

Serious gaming is an active distraction, which, compared with passive distraction, can lead to a decrease in pain behavior and reduce distress.

 

Ha, 2013

Type of study:

Randomized controlled trial.

 

Setting and country:

National Health Insurance Corporation Ilsan Hospital’s emergency room.

 

Funding:

Not reported.

 

Conflicts of interest:

Not reported.

Inclusion criteria:

- Patients between the ages of 3 and 10 years and able to communicate;

- Experienced repair of a lacerated wound smaller than 5 cm with damaged skin or subcutaneous tissue only;

- Children that did not have any brain damage or verbal, visual or auditory disturbances;

- Children whose parents or primary caregivers understood the study and agreed to participate in it.

 

Exclusion criteria:

- Children that had chronic diseases;

- Children that had complicated lacerations that were deeper than the subcutaneous tissue;

- Children that needed treatment for bone fractures or multiple injuries;

- Children that were administered drugs, such as painkillers or sedatives.

 

N total at baseline: N=84

Intervention: N=42

Control: N=42

 

Important prognostic factors2:

Age mean (SD):

I: 5.4 (2.0)

C: 6.3 (2.1)

 

3-6 years, n/N (%):

I: 30/42 (71.4%)

C: 23/42 (54.8%)

P=0.056

 

7-10 years, n/N (%):
I: 12/42 (28.6%)

C: 19/42 (45.2%)

 

Sex, n/N (%):

I: 27/42 (64.3%) M

C: 30/42 (71.4%) M

P=0.489

 

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

 

Audio visual distraction during laceration repair (DVD)

 

 

Describe  control (treatment/procedure/test):

 

No audio-visual distraction during laceration repair

Length of follow-up:

-

 

Loss-to-follow-up:

None.

 

Incomplete outcome data:

None.

 

 

Pain intensity

 

Faces Pain Rating Scale (FPRS)

 

Sensory pain response (FPRS) reported by children – pre-procedure, mean (SD):

I: 6.62 (3.11)

C: 5.48 (3.25)

P=0.103

 

Sensory pain response (FPRS) reported by children – post-procedure, mean (SD):

I: 2.71 (3.24)

C: 3.76 (3.36)

P=0.190

 

Difference pre-/post-procedure, mean (SD):

I: -3.91 (0.13)

C: -1.86 (0.11)

P<0.001

 

Visual Analogue Scale (VAS)

 

Sensory pain response (VAS) reported by primary caregivers – pre-procedure, mean (SD):

I: 63.90 (23.11)

C: 60.40 (26.79)

P=0.523

 

Sensory pain response (VAS) reported by primary caregivers –post-procedure, mean (SD):

I: 32.14 (25.38)

C: 56.52 (33.38)

P<0.001

 

Difference pre-/post-procedure, mean (SD):

I: -31.76 (2.27)

C: -3.88 (6.59)

P<0.001

 

 

Hargreaves, 1989

Type of study:

Randomized controlled trial

 

Setting and country: surgical unit of a large teaching hospital, Canada

 

Funding and conflicts of interest: The research was funded in part by a grant from the Alberta Foundation for Nursing Research to the first author. The study was conducted at the University of Alberta Hospitals, Edmonton, Canada.

Inclusion criteria: patients requiring their abdominal incisions to be cleaned and repacked after surgery (35-50 hours after surgery).

 

Exclusion criteria: not reported.

 

N total at baseline: N=75

Intervention 1: N=25

Intervention 2: 25

Control: N=25

 

Important prognostic factors2:

For example

age ± SD:

I:

C:

 

Sex:

I: % M

C: % M

 

Groups comparable at baseline? Yes

 

Describe intervention (treatment/procedure/test):

 

Intervention 1: TENS (25), electric stimulation with a pair of electrodes (pulse width of 0.4 msec and freq of 100 Hz, during the dressing change.

 

Intervention 2: Placebo TENS

 

 

 

Describe  control (treatment/procedure/test):

 

Control: No treatment

 

 

 

Length of follow-up:

 

Loss-to-follow-up:

Not reported

 

Incomplete outcome data:

Unknown.

Pain intensity

 

VAS-score, mean (SD):

I1: 3.2 (2.3)

I2: 4.5 (2.5)

C: 4.9 (2.4)

 

 

 

 

Quality assessment

Study reference

 

 

 

 

 

 

 

(first author, publication year)

Describe method of randomization1

Bias due to inadequate  concealment of allocation?2

 

 

 

 

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?3

 

 

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?3

 

 

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?3

 

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?4

 

 

 

 

 

(unlikely/likely/unclear)

Bias due to loss to follow-up?5

 

 

 

 

 

 

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?6

 

 

 

 

(unlikely/likely/unclear)

Ferraz, 2021

“Eligible patients were randomized into two groups: control group (CG) and intervention group (IG). The allocation was performed by the principal investigator, using a numerical list generated at Random.org, where the groups were randomly distributed.”

 

Unlikely

 

“The allocation was performed by the principal investigator, using a numerical list generated at Random.org, where the groups were randomly distributed.”

Likely

 

“Blindness of participants was not possible, as it was an intervention with

music.”

 

Unlikely

 

“In-ear headphones were placed on all participants, regardless of the group to which the patient was allocated, so that the professional who performed the dressing change did not know to which group the patient was assigned. This professional was instructed not to perform any additional intervention, including verbal, as well as the participants were oriented to not to not verbalize their allocation or make any question to caregiver.”

Unlikely

 

“The outcome was measured by a researcher who did not know the participant’s allocation. Blinding aimed to avoid expectation bias, a tendency to interpret the results of intervention according to the interpretation of the researcher.”

 

Unlikely

 

All predefined outcome measures were reported.

Unlikely

 

No loss to follow-up reported.

Unlikely

 

1) Participants are kept in the intervention groups to which they were randomized; 2) Outcome data are measured on all participants; and 3) all randomized participants are included in the analysis.

 

 

Ding, 2019

“Prior to surgery, each patient was randomized using a computer-generated random number table to receive either routine dressing changes or dressing changes under VR distraction.”

 

Unlikely

 

“Each patient was randomized using a computer-generated random number table.”

Likely

 

“The use of VR headsets made it impossible to use a blinded design.”

 

 

Likely

 

The use of VR headsets made it impossible to use a blinded design.”

 

Likely

 

The use of VR headsets made it impossible to use a blinded design.”

 

Unlikely

 

All predefined outcome measures were reported.

Unlikely

 

No loss to follow-up reported.

Unlikely

 

1) Participants are kept in the intervention groups to which they were randomized; 2) Outcome data are measured on all participants; and 3) all randomized participants are included in the analysis.

Guo, 2014

“In the first dressing change sequence, the 98 patients were randomly divided into an experimental group and a control group.”

 

Unclear

Likely

Unlikely

 

“In this study, to reduce the bias of the assessment process, the researchers were not directly involved in the assessment and collection of data. One researcher was trained to assist the nurses in assessing and recording the data.”

 

 

“In this study, to reduce the bias of the assessment process, the researchers were not directly involved in the assessment and collection of data. One researcher was trained to assist the nurses in assessing and recording the data.”

 

Unlikely

 

All predefined outcome measures were reported.

Unlikely

 

No loss to follow-up reported.

Unlikely

 

1) Participants are kept in the intervention groups to which they were randomized; 2) Outcome data are measured on all participants; and 3) all randomized participants are included in the analysis.

 

Nilsson, 2013

“Sixty protocols were blindly randomized and distributed in a predetermined order.”

 

Unlikely

 

“The randomization process was performed using a deck of cards. Sixty cards consisted of the following types: 20 spades (serious games), 20 diamonds (lollipops) and 20 hearts (control), were well shuffled. The cards in the deck determined the distribution of the interventions. They eventually became 60 protocols in a given order. Each one was placed in a white, unmarked envelope and when a child accepted participation in the study, the envelope on top was picked up. Twenty participants were randomized to a serious game, 20 participants to a lollipop and 20 participants to a control group.”

Likely

 

“The study was a non-blinded randomized clinical trial”

Likely

 

“The study was a non-blinded randomized clinical trial”

Likely

 

“The study was a non-blinded randomized clinical trial”

 

Unlikely

 

All predefined outcome measures were reported.

Unlikely

 

No loss to follow-up reported

Unlikely

 

1) Participants are kept in the intervention groups to which they were randomized; 2) Outcome data are measured on all participants; and 3) all randomized participants are included in the analysis.

 

Ha, 2013

“Computerized randomization was used and was placed in sealed envelopes.”

 

Unlikely

 

This randomization ensured allocation concealment.”

 

Likely

 

“The intervention process was explained to the children before it began.”

 

Likely

 

Likely

Unlikely

 

All predefined outcome measures were reported.

Unlikely

 

No loss to follow-up reported

Unlikely

 

1) Participants are kept in the intervention groups to which they were randomized; 2) Outcome data are measured on all participants; and 3) all randomized participants are included in the analysis.

Hargreaves, 1989

Subjects were randomly assigned to one of the three intervention groups.

Unclear

Unlikely

 

Placebo-TENS

Unlikely

 

 

Unclear

Unlikely

 

All predefined outcome measures were reported.

Unclear

 

Loss to follow-up was not reported.

Unlikely

 

1) Participants are kept in the intervention groups to which they were randomized; 2) Outcome data are measured on all participants; and 3) all randomized participants are included in the analysis.

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 31-05-2022

Laatst geautoriseerd  : 31-05-2022

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Heelkunde
Geautoriseerd door:
  • Nederlandse Orthopaedische Vereniging
  • Nederlandse Vereniging van Spoedeisende Hulp Artsen
  • Nederlandse Vereniging voor Dermatologie en Venereologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Medische Microbiologie
  • Nederlandse Vereniging voor Plastische Chirurgie
  • Verpleegkundigen en Verzorgenden Nederland

Algemene gegevens

De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd uit de Stichting Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.

Samenstelling werkgroep

Voor het ontwikkelen van de richtlijnmodule is in 2020 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met acute wonden.

 

Werkgroep

  • Drs. M (Michiel) Schreve, chirurg, NVvH (voorzitter)
  • Dr. M.E.N. (Maurice) Pierie, chirurg, NVvH
  • Drs. S. (Stijn) Westerbos, orthopeed, NOV
  • Dr. M.A.M. (Miriam) Loots, dermatoloog, NVDV
  • Dr. F.E. (Fleur) Brölmann, plastisch chirurg, NVPC
  • Drs. E. (Ellie) Lenselink, wondconsulent, V&VN
  • Drs. K. (Katja) Reiding, huisarts, NHG
  • Drs. L.F.J. (Lucas) Teeven, spoedeisende hulp arts i.o., NVSHA
  • Dr. M.W.F. (Martin) van Leen, specialist ouderengeneeskunde, Verenso
  • Prof. D. T. (Dirk) Ubbink, Hoogleraar Evidence-based medicine en shared decision-making

 

Meelezers

  • Dr. A. (Adinda) Klijn, spoedeisende hulp arts, NVSHA
  • Drs. C.J. (Christel) de Kuiper, verpleegkundig specialist wondmasters, V&VN
  • Dr. A.T. (Sandra) Bernards, arts-microbioloog, NVMM

 

Met ondersteuning van

  • Drs. M. (Mitchel) Griekspoor, junior adviseur, Kennisinstituut van de Federatie Medisch Specialisten
  • Dr. W.J. (Wouter) Harmsen, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
  • Dr. R. (Romy) Zwarts - van de Putte, adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Belangenverklaringen

De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.

 

Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.

 



Werkgroeplid

Functie

Nevenfuncties

Gemelde belangen

Ondernomen actie

Schreve

Vaatchirurg

Niet van toepassing

Geen

Geen

Pierie

Vaatchirurg

Niet van toepassing

Geen

Geen

Westerbos

Orthopeed

Niet van toepassing

Geen

Geen

Loots

Dermatoloog

Niet van toepassing

Geen

Geen

Brölmann

Plastisch chirurg

Niet van toepassing

Geen

Geen

Lenselink

Wondconsulent

Begeleider opleiding wondverpleegkundige, Bestuurslid V&VN, CZO opleidingscommissie, Lid stuurgroep wondopleidingen

Geen

Geen

Reiding

Huisarts

Lid commissie transmurale afspraken wondzorg voor de HOZK

Geen

Geen

Teeven

Spoedeisende hulp arts i.o.,

Niet van toepassing

Geen

Geen

Van Leen

Specialist ouderengeneeskunde

Niet van toepassing

Geen

Geen

Ubbink

Arts en klinisch epidemioloog. Hoogleraar Evidence-based medicine en shared decision-making

Niet van toepassing

Geen

Geen

De Kuiper

Verpleegkundig specialist

Niet van toepassing

Geen

Geen

Bernards

arts-microbioloog

Niet van toepassing

Geen

Geen

Inbreng patiëntenperspectief

Er werd aandacht besteed aan het patiëntenperspectief door het uitnodigen van de Patiëntenfederatie Nederland voor de Invitational conference. De Patiëntenfederatie Nederland is niet op deze uitnodiging ingegaan. De conceptrichtlijn is tevens voor commentaar voorgelegd aan de Patiëntenfederatie Nederland en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.

Methode ontwikkeling

Evidence based

Werkwijze

AGREE

Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).

 

Knelpuntenanalyse en uitgangsvragen

Tijdens de voorbereidende fase inventariseerde de werkgroep de knelpunten in de zorg voor patiënten met acute wonden. De werkgroep beoordeelde de aanbeveling(en) uit de eerdere richtlijnmodules (2013) op noodzaak tot revisie. Tevens zijn er knelpunten aangedragen door middel van een digitale Invitational conference. Een verslag hiervan is opgenomen onder aanverwante producten.

 

Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.

 

Uitkomstmaten

Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.

 

Methode literatuursamenvatting

Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur en de beoordeling van de risk-of-bias van de individuele studies is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.

 

 

Beoordelen van de kracht van het wetenschappelijke bewijs

De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding).

 

GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).

 

GRADE

Definitie

Hoog

  • er is hoge zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • het is zeer onwaarschijnlijk dat de literatuurconclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Redelijk

  • er is redelijke zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • het is mogelijk dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Laag

  • er is lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • er is een reële kans dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Zeer laag

  • er is zeer lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • de literatuurconclusie is zeer onzeker.

 

Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).

 

Overwegingen (van bewijs naar aanbeveling)

Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello, 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE-methodiek.

 

Formuleren van aanbevelingen

De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.

 

In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.

 

Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers

 

Sterke aanbeveling

Zwakke (conditionele) aanbeveling

Voor patiënten

De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet.

Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. 

Voor behandelaars

De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen.

Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren.

Voor beleidsmakers

De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid.

Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. 

 

Commentaar- en autorisatiefase

De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd.

 

Literatuur

Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.

 

Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.

 

Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.

 

Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348; PubMed Central PMCID: PMC3001530.

 

Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184; PubMed Central PMCID: PMC6542664.

 

Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html

 

Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.

 

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.

Zoekverantwoording

Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.

Volgende:
Wondzorg Instructies aan de patiënt