Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial
| Autor: | Elvira K. George, Marcel G. W. Dijkgraaf, Marc A. Benninga, Arine M. Vlieger, Obbe F. Norbruis, Carla Frankenhuis, Walther Tjon a Ten, Herbert M. van Wering, Maruschka P. Merkus, Juliette M. T. M. Rutten, Michael Groeneweg |
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| Přispěvatelé: | Paediatric Gastroenterology, ARD - Amsterdam Reproduction and Development, APH - Methodology, Clinical Research Unit, Other departments, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism |
| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_specialty Abdominal pain Hypnosis Adolescent Psychological intervention law.invention Irritable Bowel Syndrome 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law 030225 pediatrics medicine Humans Adverse effect Child Irritable bowel syndrome Netherlands Pain Measurement business.industry medicine.disease Abdominal Pain Exercise Therapy Self Care Treatment Outcome Pediatrics Perinatology and Child Health Physical therapy Functional abdominal pain syndrome 030211 gastroenterology & hepatology Female Chronic functional abdominal pain medicine.symptom business Follow-Up Studies |
| Zdroj: | JAMA pediatrics, 171(5), 470-477. American Medical Association |
| ISSN: | 2168-6211 |
| Popis: | Importance Individual gut-directed hypnotherapy (HT) is effective in pediatric irritable bowel syndrome (IBS) and functional abdominal pain or functional abdominal pain syndrome (FAP[S]). It is, however, unavailable to many children. Objective To compare the effectiveness of HT by means of home-based self-exercises using a CD with that of individual HT (iHT) performed by qualified therapists. Design, Setting, and Participants This noninferiority randomized clinical trial with a follow-up of 1 year after the end of treatment was conducted from July 15, 2011, through June 24, 2013, at 9 secondary and tertiary care centers throughout the Netherlands. A total of 303 children were eligible to participate. Of those, 260 children (aged 8-18 years) with IBS or FAP(S) were included in this study. Children were randomized (1:1 ratio) to home-based HT with a CD (CD group) or iHT performed by qualified therapists (iHT group). No children withdrew from the study because of adverse effects. Interventions The CD group was instructed to perform exercises 5 times per week or more for 3 months. The iHT group consisted of 6 sessions during 3 months. Main Outcomes and Measures Primary outcomes were treatment success directly after treatment and after 1-year follow-up. Treatment success was defined as a 50% or greater reduction in pain frequency and intensity scores. The noninferiority limit was set at 50% treatment success in the CD group, with a maximum of 25% difference in treatment success with the iHT group after 1-year follow-up. Modified intention-to-treat analyses were performed. Results A total of 132 children were assigned to the CD group and 128 to the iHT group; 250 children were analyzed (126 in the CD group and 124 in the iHT group) (mean [SD] age, 13.4 [2.9] years in the CD group and 13.3 [2.8] years in the iHT group; 94 female [74.6%] in the CD group and 85 [68.5%] in the iHT group). Directly after treatment, 46 children (36.8%) in the CD group and 62 (50.1%) in the iHT group were successfully treated. After 1-year follow-up, the 62.1% treatment success in the CD group was noninferior to the 71.0% in the iHT group (difference, −8.9%; 90% CI, −18.9% to 0.7%; P = .002). Conclusions and Relevance Long-term effectiveness of home-based HT with a CD is noninferior to iHT performed by therapists in pediatric IBS or FAP(S). Treatment with hypnosis using a CD provides an attractive treatment option for these children. Trial Registration trialregister.nl Identifier:NTR2725 |
| Databáze: | OpenAIRE |
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