Clinical Hypnosis in Pediatric Crohn's Disease



Status:Recruiting
Conditions:Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:12 - 18
Updated:2/24/2019
Start Date:February 14, 2019
End Date:May 2020
Contact:Amanda D Lee, MD
Email:amanda.d.lee@vumc.org
Phone:954-612-5896

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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.


Inclusion Criteria:

- Patients diagnosed with Crohn's disease at least 3 months prior to enrollment

- Inactive, mild, or moderate disease activity by Improve Care Now Physician's Global
Assessment (ICN PGA) at most recent GI clinic visit

- Ages 12-18 years at time of enrollment

- English-speaking and with the normal cognitive development required to understand the
verbal instructions/suggestions provided in the hypnosis session/audio recordings and
to understand and complete the written surveys

- Has daily access to an electronic device (ex. smartphone, computer) that can receive
text messages or e-mail, on which online surveys can be completed, and on which the
participant can access and listen to audio recordings.

Exclusion Criteria:

- Patients diagnosed with Crohn's disease less than 3 months prior to enrollment

- Severe disease activity per ICN PGA at most recent GI clinic visit

- Age < 12 years or > 18 years

- Non-English speaking or having a cognitive disability that precludes understanding the
verbal instructions/suggestions provided in the hypnosis session/audio recordings and
the completion of written surveys

- Lacks daily access to an electronic device (ex. smartphone, computer) that can receive
text messages or e-mail, on which online surveys can be completed, and on which the
participant can access and listen to audio recordings.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 954-612-5896
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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