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

October 9, 2025 updated by: Lily Barash, Children's Hospital at Montefiore

The Role of Audio-recorded Gut-hypnotherapy on Sleep Disturbance, Sleep-related Impairment and Abdominal Pain in Pediatric Functional Abdominal Pain Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Mahwah, New Jersey, United States, 07430
        • Children's Hospital at Montefiore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gut-directed hypnotherapy
6-week series of audio-recorded sessions of gut-directed hypnotherapy
Other: 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.
No Intervention: Standard Medical Therapy
This group continued their usual medical care for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of adherence and satisfaction to hypnotherapy treatment protocol
Time Frame: 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.
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
Time Frame: enrollment to the end of the 3-month follow up period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain
Time Frame: enrollment to the end of the 3-month follow up period
Defined as pain severity and frequency. Assessed using numerical modified abdominal pain index. Frequency and intensity scores were multiplied to yield a combined score with possible range of 0 to 50. Daily abdominal pain was assessed using Faces pain Scale- reviewed, rating pain from 0-10.
enrollment to the end of the 3-month follow up period
Functional disability
Time Frame: enrollment to the end of the 3-month follow up period
Disability is assessed and defined by the Functional Disability Inventory tool. This is a numerical tool, resulting in a total score that ranges from 0 to 60. A higher total score indicates greater degree of functional disability.
enrollment to the end of the 3-month follow up period
Anxiety
Time Frame: enrollment to the end of the 3-month follow up period
Patient- reported outcomes measurement information system (PROMIS) emotional distress-- anxiety was used to measure anxiety. 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 anxiety symptoms.
enrollment to the end of the 3-month follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital at Montefiore

Investigators

  • Principal Investigator: Rachel Borlack, Montefiore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

November 25, 2024

Study Completion (Actual)

November 25, 2024

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

October 9, 2025

First Posted (Estimated)

October 14, 2025

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 9, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-14317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is a small sample size, this will risk privacy and confidentiality for participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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