- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623932
Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease (HYPNOCROHN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Crohn disease is defined as an inflammatory chronic disease of the bowel characterize by intermittent flare-ups and remission periods.
Crohn disease is due to genetic and environmental factors such as stress. Stress is an important aggravation factor of the disease symptoms which can stop a remission period and induce a relapse into a flare-up period.
Hypnosis is a non-medicinal technic which already show efficacy in the treatment of functional digestive troubles. These diseases are bio/psycho/social models such as Crohn disease.
Hypnosis can reduce visceral pain sensibility, reduce stress and reduce pro-inflammatory cytokines liberation into intestinal mucosa.
Though, only few data are available on hypnosis interest in the treatment of Crohn disease and inflammatory bowel diseases as it is often isolated clinical case report.
One study on patients with rectocolitis in remission period has been done recently and show that hypnosis increased the duration of the remission period.
The principal objective of this study is to evaluate hypnosis efficacy in term of quality of life for patients with Crohn disease during remission.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bruno BONAZ, PU-PH
- Phone Number: 04 76 76 55 97
- Email: BBonaz@chu-grenoble.fr
Study Contact Backup
- Name: Nicolas GONNET
- Email: NGonnet@chu-grenoble.fr
Study Locations
-
-
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Grenoble, France, 38000
- Recruiting
- University Hospital
-
Contact:
- Bruno BONAZ
- Email: BBonaz@chu-grenoble.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patient with ileal or colic Crohn disease
- stable treatment for Crohn disease
- clinical and biologic remission (normal C reactive protein and fecal calprotectin < 100 µg/g)
- patient living in Grenoble area
- informed consent form
- social security affiliation
Exclusion Criteria:
- Person under legal protection (articles L1121-5 and L1121-8 of Public health code)
- Person in exclusion period of another study
- Hypnosis contraindication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: immunosuppressor/TNFalpha
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment.
|
Standard Treatment : immunosuppressor/TNFalpha as in standard practice
|
Experimental: Hypnosis + Standard Treatment
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment.
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8 hypnosis group sessions during 2 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mid term hypnosis efficacy with IBDQ
Time Frame: 6 months
|
Efficacy evaluation of hypnosis 6 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short term hypnosis efficacy with IBDQ
Time Frame: 3 months
|
Efficacy evaluation of hypnosis 3 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
|
3 months
|
Disease acceptance with ICQ-18
Time Frame: 3 months and 6 months
|
Impact of hypnosis on the disease acceptance short and mid term with the Evolution of the Illness Cognition Questionnaire for chronic disease
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3 months and 6 months
|
Clinical score with Harvey-Bradshaw Index short and mid term
Time Frame: 3 months and 6 months
|
Evolution of the clinical score short and mid term with Harvey-Bradshaw Index
|
3 months and 6 months
|
Vagal tonus with electrocardiogram
Time Frame: 3 months and 6 months
|
Evolution of the vagal tonus with electrocardiogram short and mid term
|
3 months and 6 months
|
Inflammatory status with C Reactive Protein
Time Frame: 3 months and 6 months
|
Evolution of the C Reactive Protein concentration in the plasma
|
3 months and 6 months
|
Stress with Perceived Stress Scale
Time Frame: 3 months and 6 months
|
Evolution of stress status short and mid term with Perceived Stress Scale which goes from 10 to 50.
Lower values represent better outcome.
|
3 months and 6 months
|
Fatigue with Multidimensional Fatigue Inventory
Time Frame: 3 months and 6 months
|
Evolution of fatigue status short and mid term
|
3 months and 6 months
|
Long term hypnosis efficacy
Time Frame: 12 months
|
Efficacy evaluation of hypnosis 12 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ) which goes from 32 to 224.
Higher values represent better outcome.
|
12 months
|
Clinical score with Harvey-Bradshaw Index long term
Time Frame: 12 months
|
Evolution of the clinical score long term with Harvey-Bradshaw Index
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC17.298
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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