Clinical Hypnosis in Pediatric Crohn's Disease
Condition: Pediatric Crohns Disease
MeSH terms: Crohn Disease
Study type: Interventional

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.
    


Intervention name(s): Clinical Hypnosis
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention group versus control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypnosis; inflammatory bowel disease; mind-body; brain-gut; hypnotherapy; quality of life; psychosocial