title: 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: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  trialregister.nl Identifier: NTR2725.
authors.affiliation: Department of Pediatric Gastroenterology, Emma Children's Hospital and Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Juliette M T M
authors.initials: JMTM
authors.lastname: Rutten
authors.affiliation: Department of Pediatrics, St. Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Arine M
authors.initials: AM
authors.lastname: Vlieger
authors.affiliation: Department of Pediatric Gastroenterology, Emma Children's Hospital and Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Carla
authors.initials: C
authors.lastname: Frankenhuis
authors.affiliation: Department of Pediatrics, Medical Center Alkmaar, Alkmaar, the Netherlands.
authors.forename: Elvira K
authors.initials: EK
authors.lastname: George
authors.affiliation: Department of Pediatrics, Maasstad Hospital, Rotterdam, the Netherlands.
authors.forename: Michael
authors.initials: M
authors.lastname: Groeneweg
authors.affiliation: Department of Pediatrics, Isala Clinics, Zwolle, the Netherlands.
authors.forename: Obbe F
authors.initials: OF
authors.lastname: Norbruis
authors.affiliation: Department of Pediatrics, Maxima Medical Center, Veldhoven, the Netherlands.
authors.forename: Walther
authors.initials: W
authors.lastname: Tjon A Ten
authors.affiliation: Department of Pediatrics, Amphia Hospital, Breda, the Netherlands.
authors.forename: Herbert M
authors.initials: HM
authors.lastname: van Wering
authors.affiliation: Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Marcel G W
authors.initials: MGW
authors.lastname: Dijkgraaf
authors.affiliation: Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Maruschka P
authors.initials: MP
authors.lastname: Merkus
authors.affiliation: Department of Pediatric Gastroenterology, Emma Children's Hospital and Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Benninga
mesh_terms: D015746:Abdominal Pain / Q000628:therapy*; D000293:Adolescent; D002648:Child; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006990:Hypnosis / Q000379:methods*; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D008297:Male; D009426:Netherlands; D010147:Pain Measurement; D012648:Self Care / Q000379:methods*; D016896:Treatment Outcome