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Completed

NCT Number: NCT07216092

Audio-recorded Gut-Hypnotherapy for Sleep and Pain in Pediatric 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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Disorders of Gut-brain Interaction Gastrointestinal Diseases Intestinal Diseases Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital at Montefiore

Mahwah, New Jersey, 07430, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital at Montefiore

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 14, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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