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

NCT ID: NCT07216092

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-11-25

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.

Detailed Description

Children with pain-predominant disorders of gut-brain interaction (DGBI) including irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) frequently experience sleep-related impairment, which is linked to increased pain severity, functional disability, and health care utilization. Gut-directed hypnotherapy (GDH) is an evidence-based treatment for pediatric DGBI that has been hypothesized to improve sleep, although this has not been studied. This pilot randomized controlled trial evaluates the feasibility of implementing a 6-week, audio-guided GDH program at home and explores effect sizes for sleep, abdominal pain, quality of life, and anxiety outcomes. Children ages 8-18 meeting Rome IV criteria for IBS or FAP-NOS and at least mild sleep disturbance or sleep impairment were recruited virtually from three pediatric gastroenterology centers. Participants were randomized to either standard medical therapy (SMT) or GDH; SMT participants crossed over to GDH after 6 weeks. Primary outcomes were feasibility as measured by adherence, interest, and satisfaction and sleep effect size. Secondary exploratory aims included abdominal pain, functional disability, and anxiety.

Conditions

Irritable Bowel Syndrome; Disorders of Gut-brain Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gut-directed hypnotherapy

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

Group Type: EXPERIMENTAL

Gut-directed Hypnotherapy

Intervention Type: 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.

Standard Medical Therapy

This group continued their usual medical care for 6 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gut-directed Hypnotherapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital at Montefiore

OTHER

Sponsor Role: lead

Responsible Party

Lily Barash

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Borlack

Role: PRINCIPAL_INVESTIGATOR

Montefiore

Locations

Children's Hospital at Montefiore

Mahwah, New Jersey, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19822590 (View on PubMed)

Groen J, Gordon M, Chogle A, Benninga M, Borlack R, Borrelli O, Darbari A, Dolinsek J, Khlevner J, Di Lorenzo C, Person H, Sanghavi R, Snyder J, Thapar N, Vlieger A, Sinopoulou V, Tabbers M, Saps M. ESPGHAN/NASPGHAN guidelines for treatment of irritable bowel syndrome and functional abdominal pain-not otherwise specified in children aged 4-18 years. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):442-471. doi: 10.1002/jpn3.70070. Epub 2025 May 30.

Reference Type: BACKGROUND

PMID: 40444524 (View on PubMed)

Palsson OS, van Tilburg M. Hypnosis and Guided Imagery Treatment for Gastrointestinal Disorders: Experience With Scripted Protocols Developed at the University of North Carolina. Am J Clin Hypn. 2015 Jul;58(1):5-21. doi: 10.1080/00029157.2015.1012705.

Reference Type: BACKGROUND

PMID: 26046714 (View on PubMed)

Mamoune S, Mener E, Chapron A, Poimboeuf J. Hypnotherapy and insomnia: A narrative review of the literature. Complement Ther Med. 2022 May;65:102805. doi: 10.1016/j.ctim.2022.102805. Epub 2022 Jan 21.

Reference Type: BACKGROUND

PMID: 35074550 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28346581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34917314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23568514 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39737536 (View on PubMed)

Haim A, Pillar G, Pecht A, Lerner A, Tov N, Jaffe M, Hardoff D. Sleep patterns in children and adolescents with functional recurrent abdominal pain: objective versus subjective assessment. Acta Paediatr. 2004 May;93(5):677-80.

Reference Type: BACKGROUND

PMID: 15174794 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17627965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27240555 (View on PubMed)

Murphy LK, Palermo TM, Tham SW, Stone AL, Han GT, Bruehl S, Garber J, Walker LS. Comorbid Sleep Disturbance in Adolescents with Functional Abdominal Pain. Behav Sleep Med. 2021 Jul-Aug;19(4):471-480. doi: 10.1080/15402002.2020.1781634. Epub 2020 Jun 23.

Reference Type: BACKGROUND

PMID: 32573267 (View on PubMed)

Schurman JV, Friesen CA, Dai H, Danda CE, Hyman PE, Cocjin JT. Sleep problems and functional disability in children with functional gastrointestinal disorders: an examination of the potential mediating effects of physical and emotional symptoms. BMC Gastroenterol. 2012 Oct 15;12:142. doi: 10.1186/1471-230X-12-142.

Reference Type: BACKGROUND

PMID: 23067390 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33154368 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-14317

Identifier Type: -

Identifier Source: org_study_id