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NCT07216092
Audio-recorded Gut-Hypnotherapy for Sleep and Pain in Pediatric Abdominal Pain Disorders
NA trial testing Gut-directed Hypnotherapy in Irritable Bowel Syndrome in 46 participants. Completed in 25 November 2024.
25 November 2024
Quick facts
| Lead sponsor | Children's Hospital at Montefiore |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 March 2023 |
| Primary completion | 25 November 2024 |
| Estimated completion | 25 November 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gut-directed Hypnotherapy
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
- Disorders of Gut-brain Interaction — all drugs for Disorders of Gut-brain Interaction →
Sponsor
Children's Hospital at Montefiore
Who can join
Adults 8 to 18, any sex, with Irritable Bowel Syndrome or Disorders of Gut-brain Interaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07216092
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Currently open trials in the same condition.
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Other Children's Hospital at Montefiore trials
Trials by the same sponsor.
- NCT06564662 — Rapid-Response EEG in Children With Suspected Status Epilepticus · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07216092 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital at Montefiore
- Last refreshed: 14 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07216092.
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