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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital at Montefiore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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