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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623932
Recruitment Status : Unknown
Verified March 2020 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : August 9, 2018
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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;

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: immunosuppressor/TNFalpha Behavioral: Hypnosis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective study, monocentric, controlled, randomized, open-label
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : November 12, 2021
Estimated Study Completion Date : November 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: immunosuppressor/TNFalpha
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment.
 Drug: immunosuppressor/TNFalpha
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.
 Behavioral: Hypnosis
8 hypnosis group sessions during 2 months


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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. 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

  4. Vagal tonus with electrocardiogram [ Time Frame: 3 months and 6 months ]
    Evolution of the vagal tonus with electrocardiogram short and mid term

  5. Inflammatory status with C Reactive Protein [ Time Frame: 3 months and 6 months ]
    Evolution of the C Reactive Protein concentration in the plasma

  6. 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.

  7. Fatigue with Multidimensional Fatigue Inventory [ Time Frame: 3 months and 6 months ]
    Evolution of fatigue status short and mid term

  8. 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.

  9. Clinical score with Harvey-Bradshaw Index long term [ Time Frame: 12 months ]
    Evolution of the clinical score long term with Harvey-Bradshaw Index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623932


Contacts
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Contact: Bruno BONAZ, PU-PH 04 76 76 55 97 BBonaz@chu-grenoble.fr
Contact: Nicolas GONNET NGonnet@chu-grenoble.fr

Locations
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France
University Hospital Recruiting
Grenoble, France, 38000
Contact: Bruno BONAZ       BBonaz@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03623932    
Other Study ID Numbers: 38RC17.298
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases