Methods | RCT. 2 arms. Assessed pre‐treatment, post‐treatment (3 months) | |
Participants | End of treatment n = 37 Start of treatment n = 38 Sex: 24 F, 14 M Mean age = 9.4 (SD = 1.72) Source = adverts in local newspapers and paediatricians' offices Diagnosis = functional abdominal pain or irritable bowel syndrome Mean years of pain = 34.84 months (SD = 40.7) |
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Interventions | "Hypnotherapeutic therapy" (hypnotherapeutic and behavioural methods) "Wait‐list control group" |
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Outcomes |
Primary pain outcome: mean pain intensity Primary disability outcome: Paediatric Pain Disability Index Primary depression outcome: none Primary anxiety outcome: none 1. Mean pain intensity 2. Number of days with AP 3. Mean duration of pain episodes 4. School absence 5. Paediatric Pain Disability Index 6. Parent report of Abdominal Pain Index 7. Parent report of Paediatric Pain Disability Index 8. KINDL child report (health‐related quality of life) 9. KINDL parent report (health‐related quality of life) |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Families were randomly assigned following simple randomization procedures (computerized random number generator)" Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | No description found in text Comment: probably not done |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No description found in text Comment: probably not done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition was described; differences between completers and non‐completers were not described |
Selective reporting (reporting bias) | Low risk | Data fully reported |