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)

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.