Audio-recorded Gut-Hypnotherapy for Sleep and Pain in Pediatric Abdominal Pain Disorders

NCT07216092 | Completed

• 1 other identifier: 2022-14317
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Children with irritable bowel syndrome (IBS) and functional abdominal pain- not otherwise specified (FAP-NOS) have higher rates of poor sleep quality. This can be associated with worse abdominal pain and quality of life, but few treatments target sleep. Gut-directed hypnotherapy (GDH) has been shown to reduce abdominal pain and has been hypothesized to improve sleep, but this has not been studied. This study investigates the use of a home-based audio program of GDH as a feasibility intervention for children and whether it can also help with sleep quality. Children aged 8-18 with IBS or FAP-NOS were enrolled from three children's hospitals. Participants in one group completed 6 weeks of GDH sessions at home. Sleep, abdominal pain, and daily functioning were tracked through online surveys. Participants in the control group continued their usual medical care first, and then crossed over into the GDH program.

Conditions

Irritable Bowel Syndrome; Disorders of Gut-brain Interaction

Keywords

gut-directed hypnotherapy; disorders of gut-brain interaction; irritable bowel syndrome; sleep-related impairment; sleep disturbance

Outcome Measures

Primary Outcomes (2)

• Feasibility of adherence and satisfaction to hypnotherapy treatment protocol

  Feasibility was measured through treatment adherence and participant satisfaction. Adherence was measured by number of pre-audio surveys completed and self-reported number of audios completed per week. A 5-point likert scale was used to determine enrolled participant satisfaction with hypnotherapy at the end of the intervention.

  This was assessed throughout the 6 week course by completion of daily abdominal pain surveys and at the end of the 6 week hypnotherapy course.

• Treatment effect size for Sleep Quality as measured by PROMIS Questionnaire for sleep-related impairment and sleep disturbance

  Patient- reported outcomes measurement information system (PROMIS) sleep related impairment and sleep disturbance surveys were used to measure sleep quality. This scale produces T-scores ranging from about 25-75, normalized to a population mean of 50 and a standard devision of 10. For this measure, a higher T-score indicates a greater severity of sleep related impairment or sleep disturbance.

  enrollment to the end of the 3-month follow up period

Secondary Outcomes (3)

• Abdominal pain

  enrollment to the end of the 3-month follow up period

• Functional disability

  enrollment to the end of the 3-month follow up period

• Anxiety

  enrollment to the end of the 3-month follow up period

Study Arms (2)

Gut-directed hypnotherapy

EXPERIMENTAL

6-week series of audio-recorded sessions of gut-directed hypnotherapy

Other: Gut-directed Hypnotherapy

Standard Medical Therapy

NO INTERVENTION

This group continued their usual medical care for 6 weeks

Interventions

Gut-directed Hypnotherapy OTHER

Gut-directed hypnotherapy is an evidence-based treatment that combines hypnosis with therapeutic suggestions that target the gut-brain connection. Through relaxation, imagery, and suggestions, patients learn to better control their pain.

Gut-directed hypnotherapy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English speaking
• ages 8 to 18 years
• met Rome IV criteria for FAP-NOS or IBS
• abdominal pain severity \>3/10 in the past 2 weeks
• minimum of 1 day of pain in the past 2 weeks
• mild SRI and/or SD as determined by the PROMIS 4- question short-form questionnaires
• stable medication regimen or dietary therapy for \>2 weeks prior to enrollment

You may not qualify if:

• disability that could hinder their understanding of the audio material
• previous experience with guided imagery for treatment of abdominal pain
• psychiatric disorder with psychotic elements such as dissociative symptoms
• other chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or eosinophilic esophagitis
• other chronic inflammatory conditions
• previous gastrointestinal surgery
• a diagnosis of a sleep disorder such as narcolepsy or sleep apnea.

Sponsors & Collaborators

• Children's Hospital at Montefiore: lead

Study Sites (1)

Children's Hospital at Montefiore

Mahwah, New Jersey, 07430, United States

Location

Related Publications (14)

• van Tilburg MA, Chitkara DK, Palsson OS, Turner M, Blois-Martin N, Ulshen M, Whitehead WE. Audio-recorded guided imagery treatment reduces functional abdominal pain in children: a pilot study. Pediatrics. 2009 Nov;124(5):e890-7. doi: 10.1542/peds.2009-0028. Epub 2009 Oct 12.

  PMID: 19822590 BACKGROUND

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  PMID: 40444524 BACKGROUND

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  PMID: 26046714 BACKGROUND

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  PMID: 35074550 BACKGROUND

• Rutten JMTM, Vlieger AM, Frankenhuis C, George EK, Groeneweg M, Norbruis OF, Tjon A Ten W, van Wering HM, Dijkgraaf MGW, Merkus MP, Benninga MA. 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. JAMA Pediatr. 2017 May 1;171(5):470-477. doi: 10.1001/jamapediatrics.2017.0091.

  PMID: 28346581 BACKGROUND

• Vasant DH, Hasan SS, Cruickshanks P, Whorwell PJ. Gut-focused hypnotherapy for children and adolescents with irritable bowel syndrome. Frontline Gastroenterol. 2020 Nov 23;12(7):570-577. doi: 10.1136/flgastro-2020-101679. eCollection 2021.

  PMID: 34917314 BACKGROUND

• Gulewitsch MD, Muller J, Hautzinger M, Schlarb AA. Brief hypnotherapeutic-behavioral intervention for functional abdominal pain and irritable bowel syndrome in childhood: a randomized controlled trial. Eur J Pediatr. 2013 Aug;172(8):1043-51. doi: 10.1007/s00431-013-1990-y. Epub 2013 Apr 9.

  PMID: 23568514 BACKGROUND

• Santucci NR, Velasco-Benitez CA, Velasco-Suarez DA, King C, Byars K, Dye T, Li J, Saps M. Youth With Functional Abdominal Pain Disorders Have More Sleep Disturbances. A School-Based Study. Neurogastroenterol Motil. 2025 Apr;37(4):e14992. doi: 10.1111/nmo.14992. Epub 2024 Dec 31.

  PMID: 39737536 BACKGROUND

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  PMID: 15174794 BACKGROUND

• Huntley ED, Campo JV, Dahl RE, Lewin DS. Sleep characteristics of youth with functional abdominal pain and a healthy comparison group. J Pediatr Psychol. 2007 Sep;32(8):938-49. doi: 10.1093/jpepsy/jsm032. Epub 2007 Jul 12.

  PMID: 17627965 BACKGROUND

• Patel A, Hasak S, Cassell B, Ciorba MA, Vivio EE, Kumar M, Gyawali CP, Sayuk GS. Effects of disturbed sleep on gastrointestinal and somatic pain symptoms in irritable bowel syndrome. Aliment Pharmacol Ther. 2016 Aug;44(3):246-58. doi: 10.1111/apt.13677. Epub 2016 May 30.

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  PMID: 23067390 BACKGROUND

• Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack I, Nurko S, Saps M, Shulman RJ, Szajewska H, van Tilburg MAL, Enck P. Paediatric functional abdominal pain disorders. Nat Rev Dis Primers. 2020 Nov 5;6(1):89. doi: 10.1038/s41572-020-00222-5.

  PMID: 33154368 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Parasomnias

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Rachel Borlack

  Montefiore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 14, 2025
• Study Start: March 1, 2023
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)