Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease (HYPNOCROHN)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Crohn Disease

Treatments: Drug: immunosuppressor/TNFalpha; Behavioral: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03623932

38RC17.298

Details and patient eligibility

About

Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

immunosuppressor/TNFalpha

Active Comparator group

Description:

Standard treatment with immunosuppressor and/or anti-TNFalpha treatment.

Treatment:

Drug: immunosuppressor/TNFalpha

Hypnosis + Standard Treatment

Experimental group

Description:

Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment.

Treatment:

Behavioral: Hypnosis