CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Clinical Hypnosisbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03809195
NCT03809195N/ACompleted

Clinical Hypnosis in Pediatric Crohn's Disease

Vanderbilt University Medical Center·interventional·Posted Jan 18, 2019·Updated May 28, 2020

In Brief

A clinical study evaluating Clinical Hypnosis for Pediatric Crohns Disease. Completed, enrolled 40 participants across 1 site.

Detailed 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 therapies to reduce symptoms and improve quality of life, and a biopsychosocial approach is essential in their care. The addition of hypnosis may improve outcomes through influence on stress, inflammation, coping, symptom perception, and quality of life. The investigators hypothesize that pediatric patients with CD participating in a clinical hypnosis intervention as an adjunct to standard of care will report improved quality of life compared to a waitlist control group. The specific aims of the study are as follows: (1) To implement hypnosis as an adjunctive therapy in adolescents with CD. (2) To evaluate the impact of hypnosis in CD on measures of quality of life. (3) To evaluate the impact of hypnosis in CD on pain, depression, anxiety, sleep, and coping.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 18, 2019
Enrollment StartFeb 14, 2019
Primary CompletionSep 30, 2019
Study CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.5 years ago

Interventions

Clinical Hypnosisbehavioral

See information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily.