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

March 19, 2020 updated by: University Hospital, Grenoble
Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;

Study Overview

Status

Unknown

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: immunosuppressor/TNFalpha
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment.
Standard Treatment : immunosuppressor/TNFalpha as in standard practice
Experimental: Hypnosis + Standard Treatment
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment.
8 hypnosis group sessions during 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid term hypnosis efficacy with IBDQ
Time Frame: 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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term hypnosis efficacy with IBDQ
Time Frame: 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)
3 months
Disease acceptance with ICQ-18
Time Frame: 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
3 months and 6 months
Clinical score with Harvey-Bradshaw Index short and mid term
Time Frame: 3 months and 6 months
Evolution of the clinical score short and mid term with Harvey-Bradshaw Index
3 months and 6 months
Vagal tonus with electrocardiogram
Time Frame: 3 months and 6 months
Evolution of the vagal tonus with electrocardiogram short and mid term
3 months and 6 months
Inflammatory status with C Reactive Protein
Time Frame: 3 months and 6 months
Evolution of the C Reactive Protein concentration in the plasma
3 months and 6 months
Stress with Perceived Stress Scale
Time Frame: 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.
3 months and 6 months
Fatigue with Multidimensional Fatigue Inventory
Time Frame: 3 months and 6 months
Evolution of fatigue status short and mid term
3 months and 6 months
Long term hypnosis efficacy
Time Frame: 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.
12 months
Clinical score with Harvey-Bradshaw Index long term
Time Frame: 12 months
Evolution of the clinical score long term with Harvey-Bradshaw Index
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2018

Primary Completion (Anticipated)

November 12, 2021

Study Completion (Anticipated)

November 13, 2021

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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