Crohn Disease
Conditions
Brief summary
Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;
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.
Interventions
DRUGimmunosuppressor/TNFalpha
Standard Treatment : immunosuppressor/TNFalpha as in standard practice
BEHAVIORALHypnosis
8 hypnosis group sessions during 2 months
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective study, monocentric, controlled, randomized, open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mid term hypnosis efficacy with IBDQ | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease acceptance with ICQ-18 | 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 |
| Stress with Perceived Stress Scale | 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. |
| Clinical score with Harvey-Bradshaw Index short and mid term | 3 months and 6 months | Evolution of the clinical score short and mid term with Harvey-Bradshaw Index |
| Vagal tonus with electrocardiogram | 3 months and 6 months | Evolution of the vagal tonus with electrocardiogram short and mid term |
| Short term hypnosis efficacy with IBDQ | 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) |
| Fatigue with Multidimensional Fatigue Inventory | 3 months and 6 months | Evolution of fatigue status short and mid term |
| Long term hypnosis efficacy | 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. |
| Clinical score with Harvey-Bradshaw Index long term | 12 months | Evolution of the clinical score long term with Harvey-Bradshaw Index |
| Inflammatory status with C Reactive Protein | 3 months and 6 months | Evolution of the C Reactive Protein concentration in the plasma |
Countries
France
Contacts
Primary ContactBruno BONAZ, PU-PH
Backup ContactNicolas GONNET
Outcome results
None listed