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NCT03809195 · ClinicalTrials.gov registry record · NA
Clinical Hypnosis in Pediatric Crohn's Disease
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03809195: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT03809195 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03809195, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced quality of life. Regardless of disease activity, persistent pain and psychiatric comorbidities both have a negative impact on quality of life. Alongside standard pharmacologic and nutritional therapies, clinical hypnosis is a complementary therapy that may improve physical and psychosocial outcomes in these patients. Clinical hypnosis consists of guiding the patient into a relaxed and focused state and providing therapeutic suggestions to induce desired physiologic and psychologic change. Children and adolescents are excellent candidates for hypnosis by virtue of their vivid imaginations. Hypnosis is effective in management of functional abdominal pain, irritable bowel syndrome, anxiety, chronic pain, and distress related to medical procedures. To date, there are no clinical trials that evaluate the effects of hypnosis in pediatric patients with IBD, but there is strong conceptual support for its role in improving pain and psychological distress in these patients. In addition to genetic, environmental, and microbial influences, a growing body of evidence supports the role of a dysregulated brain-gut axis and chronic stress in IBD. Animal and human studies demonstrate the effect of stress on the immune system and gastrointestinal tract. Studies show that the benefits of hypnosis may extend to its role in increasing vagal tone and regulating the immune system via the brain-gut axis. Adults with UC receiving a hypnosis intervention demonstrated improved remission and decreased inflammatory markers. Case series suggest that children with inflammatory bowel disease benefit from hypnosis, and it can be safely and easily delivered via audio recordings. Patients with IBD are interested in integrative therap
Primary Outcome
Pediatric inflammatory bowel disease-specific health-related quality of life measure. "IMPACT" is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items)
Interventions
- BEHAVIORAL Clinical Hypnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2020-05-01 |
| Phase | NA |
What the finished NCT03809195 record still lists
NCT03809195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Clinical Hypnosis is the first listed.
NCT03809195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03809195 about?
NCT03809195 is a clinical study titled "Clinical Hypnosis in Pediatric Crohn's Disease". Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced quality of life. Regardless ...
What is the current status of trial NCT03809195?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-02-14. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03809195?
The interventions under investigation include: Clinical Hypnosis (BEHAVIORAL).
Who is sponsoring clinical trial NCT03809195?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03809195's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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