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.

Abstract

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.

• Authors: Juliette M T M Rutten, Arine M Vlieger, Carla Frankenhuis, Elvira K George, Michael Groeneweg, Obbe F Norbruis, Walther Tjon A Ten, Herbert M van Wering, Marcel G W Dijkgraaf, Maruschka P Merkus, Marc A Benninga
• Journal: JAMA pediatrics (JAMA Pediatr) Vol. 171 Issue 5 Pg. 470-477 (05 01 2017) ISSN: 2168-6211 [Electronic] United States
• PMID: 28346581 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Abdominal Pain (therapy)
• Adolescent
• Child
• Exercise Therapy (methods)
• Female
• Follow-Up Studies
• Humans
• Hypnosis (methods)
• Irritable Bowel Syndrome (therapy)
• Male
• Netherlands
• Pain Measurement
• Self Care (methods)
• Treatment Outcome