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

Children's Hospital at Montefiore

Status

Completed

Conditions

Irritable Bowel Syndrome

Disorders of Gut-brain Interaction

Treatments

Other: Gut-directed Hypnotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07216092

2022-14317

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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.