Clinical trial NCT03623932: Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
Official title: Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective study, monocentric, controlled, randomized, open-label
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mid term hypnosis efficacy with IBDQ
timeFrame: 6 months
Secondary outcomes:
measure: Short term hypnosis efficacy with IBDQ
timeFrame: 3 months
measure: Disease acceptance with ICQ-18
timeFrame: 3 months and 6 months
measure: Clinical score with Harvey-Bradshaw Index short and mid term
timeFrame: 3 months and 6 months
measure: Vagal tonus with electrocardiogram
timeFrame: 3 months and 6 months
measure: Inflammatory status with C Reactive Protein
timeFrame: 3 months and 6 months
measure: Stress with Perceived Stress Scale
timeFrame: 3 months and 6 months
measure: Fatigue with Multidimensional Fatigue Inventory
timeFrame: 3 months and 6 months
measure: Long term hypnosis efficacy
timeFrame: 12 months
measure: Clinical score with Harvey-Bradshaw Index long term
timeFrame: 12 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
References: