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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2021-11-13

Brief Summary

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

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Detailed Description

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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.

Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective study, monocentric, controlled, randomized, open-label

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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immunosuppressor/TNFalpha

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

Group Type ACTIVE_COMPARATOR

immunosuppressor/TNFalpha

Intervention Type DRUG

Standard Treatment : immunosuppressor/TNFalpha as in standard practice

Hypnosis + Standard Treatment

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

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

8 hypnosis group sessions during 2 months

Interventions

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immunosuppressor/TNFalpha

Standard Treatment : immunosuppressor/TNFalpha as in standard practice

Intervention Type DRUG

Hypnosis

8 hypnosis group sessions during 2 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No