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NCT07216092 · ClinicalTrials.gov registry record · NA
Audio-recorded Gut-Hypnotherapy for Sleep and Pain in Pediatric Abdominal Pain Disorders
A NA study of Irritable Bowel Syndrome and Disorders of Gut-brain Interaction, sponsored by Children's Hospital at Montefiore.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT07216092: Completed NA study of Irritable Bowel Syndrome and Disorders of Gut-brain Interaction, sponsored by Children's Hospital at Montefiore.
NCT07216092 is a NA study of Irritable Bowel Syndrome and Disorders of Gut-brain Interaction that has completed, run by Children's Hospital at Montefiore. The registered enrollment target is 46 participants, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216092, a NA study of Irritable Bowel Syndrome and Disorders of Gut-brain Interaction, has completed, sponsored by Children's Hospital at Montefiore.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Gut-directed Hypnotherapy
Study Locations (1)
New Jersey
- Children's Hospital at Montefiore - Mahwah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2024-11-25 |
| Phase | NA |
What the finished NCT07216092 record still lists
NCT07216092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Gut-directed Hypnotherapy is the first listed.
NCT07216092 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT07216092 about?
NCT07216092 is a clinical study titled "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...
What is the current status of trial NCT07216092?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2023-03-01. Estimated completion is 2024-11-25.
What conditions does trial NCT07216092 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome, Disorders of Gut-brain Interaction.
What interventions are being tested in trial NCT07216092?
The interventions under investigation include: Gut-directed Hypnotherapy (OTHER).
Who is sponsoring clinical trial NCT07216092?
This trial is sponsored by Children's Hospital at Montefiore, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216092 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07216092's enrollment target sits among peer trials
46 35th of 47 higher than 13 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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