Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03809195
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2019-01-03
Brief Title:
Clinical Hypnosis in Pediatric Crohns Disease
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Clinical Hypnosis in Pediatric Crohns Disease
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HypnoCrohns
Brief Summary:
Inflammatory bowel disease IBD which includes Crohns 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None