Clinical Hypnosis in Pediatric Crohn's Disease (HypnoCrohns)

Vanderbilt University Medical Center

Status: Completed

Conditions: Pediatric Crohns Disease

Treatments: Behavioral: Clinical Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03809195

181436

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Hypnosis Intervention

Experimental group

Description:

The intervention is clinical hypnosis--a single in-person session followed by instructions to listen to audio recordings at home. The sessions consist of the provider's voice guiding the participant into a relaxed and focused state and providing therapeutic suggestions--for example, to replace discomfort with a more pleasant sensation, to ease anxiety, and to increase energy.

Treatment:

Behavioral: Clinical Hypnosis

Waitlist Control

No Intervention group

Description:

This group will serve as a control comparison and be offered the intervention after control data collection is complete.