Weydert 2006.
Methods | RCT with active control Follow‐up: postintervention (4 weeks) and 2 months' follow‐up |
|
Participants |
Location: USA Setting: recruited from GP referrals and paediatric gastroenterology clinics Sample size: 27 children (16 intervention, 11 control) Sex: 7 boys, 15 girls Dropouts/withdrawals: 2 intervention, 3 control (all prior to starting allocation) Diagnosis: RAP diagnosed using Apley criteria (Apley 1958) Mean age: intervention: 11.1 years (SD not reported; range not reported); control: 11.0 (SD not reported; range not reported) years. Data not reported for groups overall. |
|
Interventions |
Intervention: guided imagery and progressive muscle relaxation, for child only (individual), 60 minutes/week x 4, with daily homework Control: breathing technique training, 60 minutes/week x 4, to control for therapist time and attention, with daily homework |
|
Outcomes |
|
|
Notes |
Study dates: 2000 to June 2002 Funding: National Center for Complementary and Alternative Medicine grant Declarations of interest: Authors reported no conflicts of interest. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: blocks of 4 (tokens in a hat) |
Allocation concealment (selection bias) | Low risk | Comment: separate group responsible for randomisation |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: personnel blinded to group (both called "relaxation techniques"), but unsure of the degree of participant blinding (depends on how treatments were explained) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: researcher recording outcomes was blind to treatment allocation. Although participants self reported outcome, attempts were made to blind participants to their treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: accounts for participants |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported |
Other bias | Unclear risk | Comment: sample size calculations not reported, but otherwise well reported |
FAP: functional abdominal pain FGID: functional gastrointestinal disorders GP: general practitioner IBS: irritable bowel syndrome KINDL‐R: KINDer Lebensqualitätsfragebogen P‐PDI: Paediatric Pain Disability Index PedsQL: Pediatric Quality of Life Inventory RAP: recurrent abdominal pain RCT: randomised controlled trial SD: standard deviation