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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03623932
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Grenoble
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: immunosuppressor/TNFalpha

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

Experimental: Hypnosis + Standard Treatment

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

Interventions

Drug: - immunosuppressor/TNFalpha

Standard Treatment : immunosuppressor/TNFalpha as in standard practice

Behavioral: - Hypnosis

8 hypnosis group sessions during 2 months

Contact a Trial Team

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International Sites

University Hospital, Grenoble, France

Status

Recruiting

Address

University Hospital

Grenoble, , 38000

Site Contact

Bruno BONAZ

BBonaz@chu-grenoble.fr

04 76 76 55 97

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