Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

See, 2023

Study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs, quasi-experimental studies, cohort studies, case-control studies, and pilot studies.

Literature search between 2011 and 2021.

Source of funding and conflicts of interest:

No conflicts of interest.

Funding not reported.

Inclusion criteria SR:

• Paediatric, adults, and elderly patients
• Visiting the emergency department (ED) for any condition
• Music interventions consisting of either music listening or music therapy, as simple treatment or as co-intervention to other therapies
• All types of comparators
• English language

Exclusion criteria SR:

• Not reported

11 studies included, of which 9 studies and 2 reported of included studies. Three studies focused on the paediatric population (aged ≤21 years) (Hartling ea 2013; Park ea 2016; van der Heijden ea 2019)

Country and setting: 5 studies were conducted in the United States, 2 in Turkey, and one each from Australia, Canada, France, and South Africa

Of the studies in paediatric patients, music interventions consisted of:

• Music listening 15 min, 1 session. Music was chosen by a music therapist
• Music listening for 1 session
• Music listening for 3.43 min, 1 session. Recorded music of a repetitive and relaxing quality. The music therapist was asked to compose several original songs with a variety of rhythms, instruments, and lyrics.

Standard care, or cartoon and standard care.

Follow-up not reported.

Pain*

Pooled effect (random effect model): SMD -0.40 (95%CI -0.78 to -0.03) favouring the intervention. Heterogeneity (I²): 81%. n=2

The quality of evidence was GRADE Very low, due to the lack of blinding for RCTs (risk of bias), inconsistency (high heterogeneity), indirectness (variations in population age and music interventions), and imprecision (small sample sized with wide CIs).

Intervention subgroup

Distraction techniques

Risk of Bias

Risk of Bias assessment not provided. Authors state that due to the nature of music interventions, the quality criteria of RCTs for blinding participants, providers and outcome assessors were poorly scored.

Authors conclusion

This systematic review and meta-analysis present findings that

contribute to the evidence supporting the effectiveness of music interventions in improving pain and anxiety levels in paediatrics and adults in the EDs.

See fiure 2 for evidence table of the included studies in the review.

*Only the results in paediatric patients are reported.

Fisher, 2022*

Study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs and nonrandomised comparative observational trials (latter only for physical therapies)

Literature search between inception and March 2020.

Source of funding and conflicts of interest:

E. Fisher, G. Villanueva, N. Henschke, K Probyn, B. Buckley, and

C. Eccleston report funding from the World Health Organisation

during the conduct of the study. W. Zempsky is a consultant for

GSK, GlycoMimetics, and the Institute for Advanced Clinical

Trials for Children. He receives funding form the National

Institutes of Health and the U.S. Department of Defence. The

remaining authors have no conflicts of interest to declare

Inclusion criteria SR:

• Children (0-19 years) with chronic pain
• We included studies of children and adults if children were reported separately, made up >50% of the sample, or the mean age of the sample was <19 years.
• Eligible physical interventions had to involve bodily movement including, but not exclusively, physiotherapy, muscle strengthening, sports, and conditioning. Passive physical interventions such as massage or manipulation were excluded. Eligible psychological interventions included any that delivered recognisable psychological content
• Trials comparing interventions to active or placebo comparisons, treatment as usual, waitlist control, or other pharmacological or physical therapy interventions were included.

Exclusion criteria SR:

• Complementary and alternative therapies

24 studies in physical therapy were included, of which 33 reported of RCTs and 12 further ongoing trials (11 RCTs and 1 nonrandomised trial (of which 1 reported results)). 18 studies were included in the quantitative synthesis.

63 studies in psychological therapy were included, of which 81 reports of RCTs and 16 ongoing RCT studies.56 studies were included in the quantitative synthesis.

Country and setting:

Of the 25 trials that had results, 4 studies each were conducted in the United Kingdom and the United States, 3 in Turkey, 2 each in

Canada and Sweden, and one each in Australia, Brazil, Chile,

Denmark, India, Iran, Israel, the Netherlands, Portugal, and Saudi

Arabia.

We found 34 studies conducted in North America, 11 in Sweden,

6 in the Netherlands, 6 in Germany, 2 in Australia, and one inBrazil, Spain, Italy, and China each.

Physical trials

Physical intervention

Psychological trials

We found 43 arms of

CBT, 15 arms of relaxation, 7 arms of behavioural therapy, 3 arms

of hypnosis, 2 arms of problem-solving therapy, and one arm of

acceptance commitment therapy.

Physical trials

Nonphysical intervention

control, standard care, or waitlist control.

Psychological trials

We found 36 active control arms, 16 standard or usual care arms, and 17 waitlist control

arms (note, because some studies included multiple arms, these

numbers will not add up to 63).

Follow-up not reported.

Random effect models were used for all meta-analysis.

For the outcomes, see figure 4.

Intervention subgroup

Physical and psychological interventions

Risk of Bias

Risk of Bias assessment of physical intervention provided by Fisher 2022:

Risk of Bias assessment of psychological intervention provided by Fisher 2022:

Authors conclusion

We conducted a systematic review and meta-analysis to

determine the efficacy and safety of pharmacological, physical,

and psychological therapies for the management of chronic pain

in youth, used to support the World Health Organisation

guidelines on the management of chronic pain in children.40 We

found each modality of intervention separately showed some

benefits of reducing pain intensity posttreatment, but these

effects were not maintained at follow-up. Some physical and

psychological interventions also reduced functional disability

posttreatment, and effects were maintained for psychological

interventions at follow-up. Pharmacological and physical therapies presented very little data that could be analysed for other

outcomes, meaning any absence of effects and beneficial effects

should be interpreted with caution. Most data were available for

psychological therapies; however, we found no beneficial effects

for improving HRQOL, emotional functioning, role functioning, or

sleep in the meta-analyses. A beneficial effect of psychological

interventions was found for global satisfaction with treatment.

Adverse events were poorly reported, particularly in physical and

psychological trials.

See figure 3 for evidence table of the included studies in the review.

*Data on pharmacological interventions not reported.

Ting, 2022

Study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs, quasi-experimental studies, cohort studies, case-control studies, and pilot studies.

Literature search from inception to January 2022

Source of funding and conflicts of interest:

The authors declare no conflict of interest.

The authors of this work were supported by the following grants: MOST108-2410-H-039-003, 109-2320-B-038-057-MY3, 109-2320-B-039-066, 110-2321-B-006-004, 110-2811-B-039-507, 110-2320-B-039-048-MY2, and 110-2320-B-039-047-MY3 from the Ministry of Science and Technology, Taiwan; ANHRF109-31, 110-13, and 110-26 from An Nan Hospital, China Medical University, Tainan, Taiwan; CMRC-CMA-2 from Higher Education Sprout Project by the Ministry of Education (MOE), Taiwan; CMU108-SR-106 from the China Medical University, Taichung, Taiwan; and CMU104-S-16-01, CMU103-BC-4-1, CRS-108-048, DMR-102-076, DMR-103-084, DMR-106-225, DMR-107-204, DMR-108-216, DMR-109-102, DMR-109-244, DMR-HHC-109-11, DMR-HHC-109-12, DMR-HHC-110-10, DMR-110-124, and CMU110-AWARD-02 from the China Medical University Hospital, Taichung, Taiwan

Inclusion criteria SR:

(1) randomized controlled trials; (2) intervention group receiving music intervention that included all three factors of music (i.e., rhythm, melody, and harmony); (3) outcome assessments included pain measures; (4) age of all participants was less than 18 years.

Exclusion criteria SR:

(1) reviews, protocols, conference papers, case reports, letters, or editorials; (2) MI was administered with other types of therapy or was a part of complementary and alternative therapy; (3) the control group received any components of music, i.e., rhythm, melody, and harmony; (4) studies that did not provide information for meta-analysis.

38 studies included, which were all included in the meat-analysis.

Country and setting:

Eight rticles were conducted in America, 14 in Europe, 13 in Asia, and three in Africa. 29 studies were conducted in the hospital setting and 9 in the clinic setting.

Two articles included adolescents, 12 newborns, and 24 infants and children.

8 articles included patients with postoperative pain.

Listening to music.

Among all 38 studies, the participants listened to classical music in 11 articles, to kids’ music in 8 articles, to world music in 3 articles, to pop music in 3 articles, to special composition in 5 articles, and to multiple combinations of music in 4 articles. Additionally, in one article, two groups of participants listened to either kids’ music or world music, and thus this article was separated into two datasets. As for the listening instruments, 9 articles used headphones, 4 used earphones, 19 used speakers, and 4 used live performance. In one article, participants listened to music using either headphones or speakers, and thus this study was separated into two datasets.

Music control (not further described, but the control group does not receive any components of music)

Follow-up not reported.

Pain release*

Pooled effect (random effect model): SMD -0.49 (95%CI -0.90 to -0.08, p=0.018) favouring the intervention. Heterogeneity (I²): 81%. n=8

Intervention subgroup

Distraction techniques

Risk of Bias

Risk of Bias assessment provided by Ting et al., 2022:

Authors conclusion

Our meta-analysis of 38 RCT articles with a total of 5601 participants provides evidence supporting the thesis that MI releases pain in both psychological and physiological domains. A consistent music style and a pure auditory experience might be important in MI for pain. MI is an appropriate, low-stress, and safe non-pharmacological treatment for clinical pain relief in the paediatric population.

No evidence table provided.

*Only the results of patients with postoperative pain are reported.

Koechlin, 2021

SR and network meta-analysis of RCTs

Literature search from inception to August 5, 2019

Source of funding and conflicts of interest:

The authors declare no conflict of interest.

Dr Koechlin is sponsored by the Swiss National Science Foundation fellowship P400PS_186658. Dr Locher received funding for this project from the Swiss National Science Foundation: P400PS_180730. Dr Meissner received support from the Schweizer-Arau-Foundation and the Theophrastus Foundation, Germany. This work was supported in part by the Sara Page Mayo Endowment for Pediatric Pain Research, Education, and Treatment.

Inclusion criteria SR:

Nonpharmacological interventions for children and adolescents <18 years were included in this study. Participants had to have a diagnosis of episodic migraine (with or without aura) according to the International Headache Society (IHS) criteria, or criteria for migraine diagnosis had to be in close agreement with the IHS classification. Trials had to specifically state that they were focusing on paediatric migraine but were not required to specify the exact diagnosis of migraine to be included. Eligible trial designs included RCTs that make head-to-head comparisons of at least 2 nonpharmacological interventions as well as RCTs that compare at least 1 nonpharmacological intervention with a control group. To be included, trials had to report at least 1 migraine-related outcome. Crossover studies were only included if we were able to extract the results of the first period separately.

Exclusion criteria SR:

Studies in which migraine was associated with other neurologic disorders as well as studies on menstrual migraine were excluded.

12 studies were included. 2 other studies were excluded because they did not connect with the other studies in the network.

Country and setting:

Six (5%) of the included trials recruited children and adolescents from the United States, 3 (25%) from Europe, and 3 (25%) from Canada.

Relaxation stress management, relaxation education, relaxation, biofeedback, biofeedback stress management, biofeedback relaxation education, transcendental meditation, autogenic feedback, autogenic training, psychological treatments, progressive muscle relaxation, self-administered psychological treatments, education, and hypnotherapy

Psychological placebo, sham biofeedback, and waiting list

Follow-up not reported.

Lumping approach* (interventions combined into one group)

Short term efficacy

Self-administered treatments (SMD: 1.44; 95% CI, 0.26 to 2.62), biofeedback (SMD: 1.41; 95% CI, 0.64 to 2.17), relaxation (SMD: 1.38; 95% CI, 0.61 to 2.14), psychological treatments (SMD: 1.36; 95% CI, 0.15 to 2.57), and psychological placebos (SMD: 1.17; 95% CI, 0.06 to 2.27) were significantly more effective than the waiting list.

Long-term efficacy

Self-administered treatments (SMD: 1.40; 95% CI, 0.28 to 2.52), relaxation (SMD: 1.35; 95% CI, 0.60 to 2.09), psychological treatments (SMD: 1.33; 95% CI, 0.18 to 2.47), biofeedback (SMD: 1.21; 95% CI, 0.47 to 1.94), and psychological placebos (SMD: 1.14; 95% CI, 0.09 to 2.19) revealed significantly higher effects than the waiting list.

Splitting approach* (less heterogeneity because interventions are split into groups)

Short-term efficacy

No nonpharmacological intervention was significantly more effective than the waiting list. There were no significant differences between the included nonpharmacological interventions.

Long-term efficacy

No nonpharmacological intervention was significantly more effective than the waiting list. None of the included nonpharmacological interventions did differ significantly from one another.

*Outcomes were (1) number of headache days per month, (2) the number of migraine days per month, (3) frequency of headache attacks (means and SDs), (4) frequency of migraine attacks (means and SDs), or (5) headache index and activity.

Intervention subgroup

Psychoeducation, distraction techniques, therapeutic communication

Quality assessment

See https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Faap2.silverchair-cdn.com%2Faap2%2Fcontent_public%2Fjournal%2Fpediatrics%2F147%2F4%2F10.1542_peds.2019-4107%2F1%2Fpeds_20194107supplementarydata.doc%3FExpires%3D1705498669%26Signature%3DDntYW92gQkpbZfMHFqAbrI3Tbb7J~ozzJ3zZzG7y-WaxLcmNBZ4nRbDqkHuGDPhb~2GpB8zKUpGDavelrYWm59RAQxmq~djBTXQxBQUy2YsddVvvQ4Orfts1rNzexXYJ~ukZeRWs2LM9NpOFWJgTpLYpLssIfR2rIPspdnmXRGZSQY1M7DUQcog4acEk~F5aAXHAh0q8~3vc8oOR-UtsmVcSzeSOryjuNSw1A-uu3ve6UNrE2JTjPQ4xiorl6R5jFmDzhUA1~0HxaGWxqzfCDZRqq5JHWNYQ7Cqo95Ryw07MahN8FVDqoyIBJX7jWXR~HMuXlc7NY3ddyMhk7f8gqw__%26Key-Pair-Id%3DAPKAIE5G5CRDK6RD3PGA&wdOrigin=BROWSELINKhttp GRADE assessments.

Authors conclusion

Interestingly, our NMA revealed different findings depending on the structure of the nodes in the network. In a first step, we lumped the interventions into broader classes. Significant short- and long-term effects were found for most nonpharmacological interventions (ie, relaxation, biofeedback, psychological treatments, and self-administered psychological treatments) as well as for 1 control group (ie, psychological placebo) when compared with the waiting list. In terms of our second aim (ie, to systematically compare the different nonpharmacological treatment options relative to each other), the included interventions did not significantly differ from one another. In a second step, we split the various published interventions into individual nodes. Here, in the short- and long-term analyses, none of the included interventions were significantly more effective than the waiting list, which was the control group that most interventions were compared with and that connected 2 otherwise unconnected networks. Also, none of the interventions differed significantly from each other in the head-to-head comparisons.

See https://publications.aap.org/view-large/8236846https://punce table of the included studies in the review.

Abbott, 2017

SR and meta-analysis of RCTs

Literature search up to June 2016

Source of funding and conflicts of interest:

The authors declare no conflict of interest.

The work of the evidence synthesis team is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula (PenCLAHRC). However, the funder had no role in the review itself.

Inclusion criteria SR:

• The control group in the RCT could be usual care, wait‐list control, or an active form of control that is not considered to be a psychosocial intervention.
• Children and adolescents aged 5 to 18 years with recurrent abdominal pain or an abdominal pain‐related functional gastrointestinal disorder as defined by the Rome III criteria
• Any psychosocial intervention (intervention based on psychological or behavioural theory) compared to usual care, wait‐list control, or active control. Active control groups were deemed eligible if they were considered to be comparable to what a clinician may already provide or suggest, for example education, advice, or relaxation.

Exclusion criteria SR:

Not reported

18 studies were included (from 26 reports). 2 studies (from 2 reports) awaiting classification and 14 studies were included in the meta-analysis.

Country and setting:

The majoity of studies recruited children through paediatric gastroenterology or paediatric pain clinics.

Eight studies were conducted in the USA, three in the Netherlands, two in Germany, two in Australia, one in Canada, one in Brazil, and one recruiting from both the USA and Canada.

Cognitive behaviour therapy (CBT), hypnotherapy (including guided imagery), yoga, written self-disclosure.

The comparator was usual medical care in six studies, a wait‐list control in eight studies, and an education or breathing control, or both, in four studies. However, meta-analysis are compared with usual care or wait-list control.

Follow-up not reported.

CBT

Pain intensity: postintervention

Pooled effect (random effect model): SMD -0.33 (95%CI -0.74 to 0.08, p=0.12) favouring the intervention. Heterogeneity (I²): 70%. n=7. GRADE low.

Pain intensity: between 3 to 12 months follow-up

Pooled effect (random effect model): SMD -0.32 (95%CI -0.85 to 0.20, p=0.23) favouring the intervention. Heterogeneity (I²): 76%. n=4. GRADE low.

Pain intensity: 12 months or more follow-up

Pooled effect (random effect model): SMD -0.04 (95%CI -0.39 to 0.31, p=0.82) favouring the intervention. Heterogeneity (I²): 52%. n=3. GRADE low.

Pain duration

There was no evidence of effect of intervention compared with active control on pain duration at any time point (postintervention mean: 8.67 intervention, 6.84 control, P = 0.96; 6 months' mean: 5.34 intervention, 8.58 control, P = 0.25; 12 months' mean: 6.11 intervention, 6.89 control, P = 0.80 (no SDs reported)). n=1

Social or psychological functioning

Three studies reported outcomes related to social or psychological functioning, all of which found no effect of therapy when compared to control.

Quality of life (physical subscale)

Pooled effect (random effect model): SMD 0.71 (95%CI ‐0.25 to 1.66, p=0.15) favouring the intervention. Heterogeneity (I²): 79%. n=3. GRADE very low.

Quality of life (psychosocial subscale)

Pooled effect (random effect model): SMD 0.43 (95%CI ‐0.21 to 1.06, p=0.19) favouring the intervention. Heterogeneity (I²): 58%. n=3. GRADE low.

Functional impairment of daily activities

Pooled effect (random effect model): SMD -0.57 (95%CI ‐1.34 to 0.19, p=0.14) favouring the intervention. Heterogeneity (I²): 80%. n=4. GRADE very low.

Hypnotherapy

Pain intensity: postintervention

Pooled effect (random effect model): SMD -1.01 (95%CI -1.41 to -0.61, p<0.00001) favouring the intervention. Heterogeneity (I²): 21%. n=4. GRADE low.

Pain intensity: 5 year follow-up

n=1

Pain intensity remained significantly lower at five years (P < 0.001) in the group that had received three months of hypnotherapy (mean 2.9 (SD 4.4)) compared to the group that had received usual care (mean 7.7 (SD 5.3)).

Pain frequency: postintervention

Pooled effect (random effect model): SMD -1.28 (95%CI -1.84 to -0.72 p<0.00001) favouring the intervention. Heterogeneity (I²): 55%. n=4. GRADE low.

Pain frequency: 5 year follow-up

n=1

Pain frequency remained significantly lower (P = 0.001) in the group that had received hypnotherapy (mean 2.3 (SD 4.0)) compared to the group that had received usual care (mean 7.1 (SD 6.0)).

Pain duration

n=1

They reported pain duration as significantly lower for the 20 children who had received hypnotherapy compared to those in the wait‐list control group, with mean scores of 1.20 (SD 1.47) compared to 3.50 (SD 2.53), P = 0.014, respectively.

Quality of life

One study found no difference in self-repoted health‐related quality of life for those receiving hypnotherapy compared to wait‐list control.

One study found that children who had received guided imagery therapy reported an improved overall quality of life (mean 28.2) compared to those in the wait‐list control group (mean 9.3) at postintervention (P = 0.49, no SDs reported).

One study reported that there were no differences in quality of life at five‐year follow‐up between those who had received hypnotherapy compared to usual care control.

Yoga

Pain intensity: postintervention

Pooled effect (random effect model): SMD -0.31 (95%CI -0.67 to 0.05, p=0.09) favouring the intervention. Heterogeneity (I²): 0%. n=3. GRADE low.

Pain intensity: 12-month follow-up

One study found no significant effect over time for the yoga intervention compared to usual care (P = 0.09).

Pain frequency: postintervention, 6 month, 12-month follow-up

One study reported no significant effect of yoga compared to usual care on pain frequency across the three follow‐ups (postintervention, 6 months, and 12 months; P = 0.20).

Social or psychological functioning

None of the three studies reported significant effects of yoga intervention on social or psychological functioning.

Functional disability

Pooled effect (random effect model): SMD -0.32 (95%CI -1.07 to 0.43, p=0.40) favouring the intervention. Heterogeneity (I²): 44%. n=2. GRADE low.

Written self-disclosure

Pain frequency

No effect of treatment on the frequency of debilitating pain episodes (using a scale of 0 to 5, where 0 = none and 5 = every day) was found postintervention or at three months' follow‐up. However, at six months' follow‐up the frequency of such episodes was lower (P < 0.05, exact P value not in report) in those who had undergone written self‐disclosure (mean 1.35 (SD 1.39)) compared to usual care (mean 2.32 (SD 1.72)).

Intervention subgroup

Psychoeducation, therapeutic communication

Risk of Bias

Risk of Bias assessment provided by Abbott et al., 2017:

Authors conclusion

Overall, this review provides low‐quality evidence that cognitive behavioural therapy (CBT) and hypnotherapy may be effective in reducing pain in the short term for children and adolescents presenting with recurrent abdominal pain (RAP). Sustained effects of both CBT and hypnotherapy on pain have also been reported, but the evidence to date is limited. There was little evidence that CBT or hypnotherapy affected school functioning, psychological well‐being, or quality of life.

This review found no evidence to support the use of yoga or written self‐disclosure for the treatment of recurrent abdominal pain in children and adolescents.

See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464036/#CD010971-sec-0155title for evidence tables of the included studies in the review.

Gordon, 2022

Study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs

Literature search from inception to August 2021

Source of funding and conflicts of interest:

The authors declare no conflict of interest.

Funding is not reported

Inclusion criteria SR:

Included in this systematic review and meta-analysis were all published, unpublished, and ongoing RCTs that compared psychosocial interventions to any intervention or control and studies that targeted at children aged 4 to 18 years with functional abdominal pain disorders as defined by the Rome or similar criteria. There were no date or language restrictions.

Exclusion criteria SR:

Not reported.

33 studies included (67 citations), of which 26 were included in the mete-analysis.

Country and setting:

Not reported.

Twelve studies compared CBT with no intervention, 5 studies compared CBT with educational support, 3 studies compared yoga with no intervention, 2 studies compared hypnotherapy with no intervention, 2 studies compared gut-directed hypnotherapy with hypnotherapy, and 2 studies compared guided imagery with relaxation.

See previous column

Length of follow-up lasted from 5 days to 4 months.

CBT*

Pain frequency

Pooled effect (random effect model): SMD -0.36 (95%CI -0.63 to -0.09) favouring the intervention. Heterogeneity (I²): 46%. n=7. GRADE moderate.**

Pain intensity

Pooled effect (random effect model): SMD -0.58 (95%CI -0.83 to -0.32) favouring the intervention. Heterogeneity (I²): 19%. n=6. GRADE moderate.**

Yoga*

Pain frequency and intensity

One study reported pain frequency and intensity and another change in pain frequency. However, the results of the meta-analyses were of very low certainty in evidence owing to high imprecision and risk of bias, and no conclusions could be drawn.

Hypnotherapy*

Pain frequency, pain intensity, and composite pain score

One study reported this, but the results of the meta-analyses were of very low certainty owing to high imprecision and risk of bias, and no conclusions could be drawn.

Intervention subgroup

Psychoeducation, therapeutic communication

Risk of Bias

Risk of Bias assessment provided by Gordon et al., 2022:

Authors conclusion

Results of this systematic review and meta-analysis suggest that CBT and hypnotherapy should be considered as a treatment for functional abdominal pain disorders in childhood, and these new findings should be considered by guideline committees internationally. Future RCTs should address sample size and precision issues in integral areas to enhance overall certainty; in addition, studies should also consider the role of targeted interventions for susceptible patients. CBT combined with a pharmacological or microbiome-based therapy may be considered.

See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9002716/bin/jamapediatr-e220313-s001.pdfhttps://w) for evidence tables of the included studies in the review.

*Only results of intervention versus no intervention reported here.

** Study reports SMD in figure and RR in text. Due to the outcome measure, we assumed that SMD is right.

Abbott, 2018

SR and meta-analysis of RCTs and randomised cross-over trials

Literature search up to November 21, 2017

Source of funding and conflicts of interest:

Conflict of interest not reported.

This research was funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Inclusion criteria SR:

Children aged 5 to 18 years old with RAP or an abdominal pain-related functional gastrointestinal disorder, as defined by the Rome III criteria (13), were included. Any dietary, pharmacological, or psychosocial intervention compared to placebo, waiting list, no treatment, active control (psychosocial interventions only), or standard care were included. Included studies were restricted to randomised controlled trials (RCTs) and randomised cross-over studies.

Exclusion criteria SR:

Not reported

52 studies included in 3 Cochrane reviews. 3 additional studies were included on update search in Nov 2017.

Country and setting:

The studies were conducted in 15 countries, recruiting children from secondary/tertiary paediatric gastroenterology or pain clinics (n = 37), primary care (n = 1), the community (n = 1), or from a combination of these (n = 10), or not described (n = 3).

Psychosocial interventions*

Placebo, waiting list, no treatment, active control, or standard care

Follow-up not reported.

BT**

Pain intensity: postintervention

Pooled effect (random effect model): OR 5.67 (95%CI 1.18 to 27.32, p=0.03) favouring the intervention. Heterogeneity (I²): 71%. NNTB = 4. n=4.

Pain intensity: between 3 to 6 months follow-up

Pooled effect (random effect model): OR 3.08 (95%CI 0.93 to 10.16, p=0.06) favouring the intervention. NNTB = 5. n=3

Pain intensity: 12 months or more follow-up

Pooled effect (random effect model): OR 1.29 (95%CI 0.50 to 3.33, p=0.60) favouring the intervention. n=2.

Hypnotherapy

Pain intensity: postintervention

Pooled effect (random effect model): OR 6.78 (95%CI 2.41 to 19.07, p<0.0003) favouring the intervention. Heterogeneity (I²): 23%. NNTB = 3. n=4.

Intervention subgroup

Psychoeducation

Risk of Bias

Not provided.

Authors conclusion

The review also found low-quality evidence to suggest that CBT and hypnotherapy may be effective in treating RAP, with both reported to be effective in reducing pain in the short term. Sustained effects of CBT and hypnotherapy were also reported but the evidence is limited. We found insufficient evidence to support the use of yoga therapy or written self-disclosure.

*Data on dietary and pharmacological interventions not reported here.

**This article is a summary and update of three reviews, including the review of Abbott 2017. This review is described above, only the different results of CBT and hypnotherapy are described (yoga and written self-disclosure is therefore not described here).

See figure 5 for the characteristics of the included studies.

Study

First author, year

Appropriate and clearly focused question?¹

Yes/no/unclear

Comprehensive and systematic literature search?²

Yes/no/unclear

Description of included and excluded studies?³

Yes/no/unclear

Description of relevant characteristics of included studies?⁴

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?⁵

Yes/no/unclear/not applicable

Assessment of scientific quality of included studies?⁶

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?⁷

Yes/no/unclear

Potential risk of publication bias taken into account?⁸

Yes/no/unclear

Potential conflicts of interest reported?⁹

Yes/no/unclear

Risk of bias

See, 2023

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Unclear

Yes

Low

Fisher, 2022

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Low

Ting, 2022

Yes

Yes

Yes

No

Not applicable

Yes

Yes

Yes

No

High

Koechlin, 2021

Yes

Yes

Yes

Yes

Not applicable

Yes

Yes

Yes

No

Low

Abbott, 2017

Yes

Yes

Yes

Yes

Not applicable

Yes

Yes

Yes

Yes

Low

Gordon, 2022

Yes

Yes

Yes

Yes

Not applicable

Yes

Yes

No

No

Some concerns

Abbott, 2018

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

No

Low

Title

Author

Year

Reason

Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis

Lier

2023

Children not reported separately

Using Virtual Reality Exposure Therapy in Pain Management: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Huang

2022

Study includes children and adults and procedural and non procedural pain. No results for children with non procedural pain are reported separately.

Effectiveness of psychosocial interventions on health outcomes of children with cancer: A systematic review of randomised controlled trials

Melesse

2022

No results on pain were reported

Effect of a game-based intervention on preoperative pain and anxiety in children: A systematic review and meta-analysis

Suleiman-Martos

2022

Wrong C: children in the control group in some studies also receive other distraction methods (multimedia player, VR video + parents watching the same video, bedside entertainment and relaxation theatre)

The Benefits of Integrative Medicine for Pain Management in Oncology: A Narrative Review of the Current Evidence

Carvalho

2023

Children not reported separately, included studies about children also not suitable for the PICO

Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline

Mao

2022

Children not reported separately, evidence extraction cannot be found in the guideline

The physical and psychological outcomes of art therapy in pediatric palliative care: A systematic review

Motlagh

2023

5 of 17 studies were before-after studies. 4 studies reported on pain, of which 2 were non-RCTs

A systematic review of psychosocial therapies for children with rheumatic diseases

Cohen

2017

One study compares cognitive behaviour therapy with wait-list control, see cell A69.
Other included studies report active comparison

American Society of Hematology 2020 guidelines for sickle cell disease: Management of acute and chronic pain

Brandow

2020

Two pre-post studies could be suitable, see cell A69 and A70. Other studies were not in children.

Pain management in COVID-19 pediatric patients - An evidence- based review

Mishra

2021

Wrong I: other nonpharmacological treatments than in our PICO (drink water/warm bath/etc)

Nonpharmacological interventions addressing pain, sleep, and quality of life in children and adolescents with primary headache: A systematic review

Klausen

2019

Wrong C: waiting list control, telephone contact, or webbased CD rom

Effect of music on patients with cardiovascular diseases and during cardiovascular interventions: A systematic review

Ho

2021

Review includes no studies in children measuring pain

The effectiveness of play therapy in children with leukemia: A systematic review

Ramdaniati

2023

Wrong O: doen not report pain quantitatively

A Systematic Review of Occupational Therapy-Related Interventions for Pediatric Chronic Pain

Suder

2023

Control not described

Adjunctive Nonpharmacologic Interventions for the Management of Burn Pain: A Systematic Review

Gasteratos

2022

Children not reported separately

Complementary and alternative medicine for children with sickle cell disease: A systematic review

Alsabri

2023

Wrong aim: cross sectional studies info the use of CAM

Control effect of virtual reality technology on procedural pain in children's wound: A meta-analysis

Li

2022

Wrong I: VR for procedural pain

Does virtual reality reduce pain in pediatric patients? A systematic review

Iannicelli

2019

Wrong I: VR for procedural pain

Effectiveness of complementary therapies for the management of symptom clusters in palliative care in pediatric oncology: a systematic review

Lopes-Júnior

2021

wrong I: complementary therapy

Effectiveness of Hospital Clowning on Pediatric Anxiety and Pain: Network Meta-Analysis

Caci

2023

Medical procedure

Effectiveness of hospital clowns for symptom management in paediatrics: Systematic review of randomised and non-randomised controlled trials

Lopes-Júnior

2020

Outcome pain only reported during procedures, anxiety also reported before the procedure and during the induction of anaethesia --> prodecures

Effectiveness of virtual reality interventions for adolescent patients in hospital settings: Systematic review

Ridout

2021

One study reported that measures pain during chemotherapy using VR compared to standard care. This study can be extracted, see cell A71.

Effects of Infant Massage: A Systematic Review

Mrljak

2022

One study included was performed in children with non procedural pain. These study data can be extracted, see cell A72.

Effects of non-pharmacological interventions on pain intensity of children with burns: A systematic review and meta-analysis

Farzan

2023

Some of the included studies compared with standard care or pharmacotherapy and some with other distraction methods (television, stories, toys) + procedures (burn wound care, physical therapy, dressing application, dressing removal)

Efficacy and safety of non-pharmacological interventions for endotracheal suctioning pain in preterm infants: A systematic review

Cai

2023

Procedure (endotracheal suctioning)

Efficacy and safety of non-pharmacological interventions for neonatal pain: an overview of systematic reviews

Shen

2022

Procedural pain

Efficacy of non-pharmacological interventions to reduce pain in children with sickle cell disease: A systematic review

van Veelen

2023

Wrong C: education and also includes articles without control. However, three articles could be suitable, see A74.

Examining the effects of music-based interventions on pain and anxiety in hospitalized children: An integrative review

Johnson

2021

Procedures

Extended Reality Use in Paediatric Intensive Care: A Scoping Review

Goldsworthy

2023

Wrong design: description of studies but no effects described + no control groups described

Holistic Comfort Interventions for Pediatric Nursing Procedures: A Systematic Review

Bice

2017

Wrong I: procedural comfort interventions

Immersive and Non-Immersive Virtual Reality for Pain and Anxiety Management in Pediatric Patients with Hematological or Solid Cancer: A Systematic Review

Comparcini

2023

One study could be suitable, see A78

Immersive Virtual Reality as Analgesia during Dressing Changes of Hospitalized Children and Adolescents with Burns: A Systematic Review with Meta-Analysis

Lauwens

2020

Procedure

Impact of Virtual Reality Technology on Pain and Anxiety in Pediatric Burn Patients: A Systematic Review and Meta-Analysis

Smith

2022

Procedure

Improving vaccine-related pain, distress or fear in healthy children and adolescents–a systematic search of patient-focused interventions

Lee

2018

Procedure? Results are reported separately so can be extracted per included study

Infants born preterm, stress, and neurodevelopment in the neonatal intensive care unit: might music have an impact?

Anderson

2018

Study selected the 10 most methodologically stringent and relevant articles

Interventions for postoperative pain in children: An overview of systematic reviews

Boric

2017

Twee studies kunnen wel geschikt zijn, zie A80 en A81

Management of routine postoperative pain for children undergoing cardiac surgery: A Paediatric Acute Care Cardiology Collaborative Clinical Practice Guideline

Gal

2022

Gebruiken voor overwegingen

Maternal voice reduces procedural pain in neonates: A meta-Analysis of randomized controlled trials

Jin

2023

Procedure

Medical clowning in hospitalized children: a meta-analysis

Kasem Ali Sliman

2023

Procedure

MUSIC INTERVENTIONS IN PEDIATRIC ONCOLOGY: Systematic review and meta-analysis

da Silva Santa

2021

Some interventions are combined music interventions and some controls were active controls

Music-based interventions in paediatric and adolescents oncology patients: A systematic review

González-Martín-Moreno

2021

One study could be suitable, see A83

Nonpharmacologic Intervention on the Prevention of Pain and Anxiety During Pediatric Dental Care: A Systematic Review

Goettems

2017

Dental treatment no hospital care

Non-pharmacological and non-surgical treatment of pain in children and adolescents with cerebral palsy: A scoping review

Flyckt

2022

Included studies with interventions within PICO are not suitable (interviews and surveys)

Nonpharmacological Applications during the Retinopathy of Prematurity Examination and Their Effects on Pain Control: A Systematic Review and Meta-analysis

Erçelik

2022

Wrong I: sucrose, glucose, and breast milk

Non-Pharmacological Management for Vaccine-Related Pain in Children in the Healthcare Setting: A Scoping Review

Wu

2022

Not all included studies use standard care as control. Results are reported per type of intervention. + scoping review

Non-pharmacological options for managing chronic musculoskeletal pain in children with pediatric rheumatic disease: a systematic review

Nijhof

2018

Wrong C: active comparator. However, some studies could be suitable, see A85, A86, A87

Non-pharmacological pain interventions for sickle cell crisis in pediatrics: A scoping review

Ibitoye

2023

Wrong aim: overview of which interventions are used in patients with sickle cell crisis

Non-pharmacological pain relief during orthodontic treatment

Aljubaibi

2018

Wrong design: summary review. Original article does not perform a subgroup analysis in children and adults, and is therefore not suitable.

Pediatric Complex Regional Pain Syndrome and Occupational Therapy Intervention: A Scoping Review

Tay

2023

Wrong studies included: qualitative studies and reviews that are not suitable

Pediatric Distraction Tools for Prehospital Care of Pain and Distress: A Systematic Review

Robinson

2023

Procedures

The Effect of Music Therapy Applied to Neonatales on their Pain: Systematic Review

Terzi

2023

No control group reported and procedures included

The impact of music, play, and pet therapies in managing pain and anxiety in paediatric patients in hospital: a rapid systematic review

Goren

2023

4 of 24 studies had no standard care as comparator.

Virtual reality distraction for acute pain in children

Lambert

2020

Procedure

Virtual Reality Technology for Pain and Anxiety Management among Patients with Cancer: A Systematic Review

Ahmad

2020

No included studies in children without procedures performed

Virtual Reality Therapy to Control Burn Pain: Systematic Review of Randomized Controlled Trials

De Jesus Catalã

2022

Results not described properly

The effectiveness of web-based mobile health interventions in paediatric outpatient surgery: A systematic review and meta-analysis of randomized controlled trials.

Rantala

2020

Procedure