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

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
immunosuppressor/TNFalpha
Hypnosis
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Crohn Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

immunosuppressor/TNFalpha

Hypnosis + Standard Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mid term hypnosis efficacy with IBDQ
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

Short term hypnosis efficacy with IBDQ
Efficacy evaluation of hypnosis 3 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
Disease acceptance with ICQ-18
Impact of hypnosis on the disease acceptance short and mid term with the Evolution of the Illness Cognition Questionnaire for chronic disease
Clinical score with Harvey-Bradshaw Index short and mid term
Evolution of the clinical score short and mid term with Harvey-Bradshaw Index
Vagal tonus with electrocardiogram
Evolution of the vagal tonus with electrocardiogram short and mid term
Inflammatory status with C Reactive Protein
Evolution of the C Reactive Protein concentration in the plasma
Stress with Perceived Stress Scale
Evolution of stress status short and mid term with Perceived Stress Scale which goes from 10 to 50. Lower values represent better outcome.
Fatigue with Multidimensional Fatigue Inventory
Evolution of fatigue status short and mid term
Long term hypnosis efficacy
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.
Clinical score with Harvey-Bradshaw Index long term
Evolution of the clinical score long term with Harvey-Bradshaw Index

Full Information

First Posted
July 4, 2018
Last Updated
March 19, 2020
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03623932
Brief Title
Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
Acronym
HYPNOCROHN
Official Title
Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
November 12, 2021 (Anticipated)
Study Completion Date
November 13, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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;
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective study, monocentric, controlled, randomized, open-label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
immunosuppressor/TNFalpha
Arm Type
Active Comparator
Arm Description
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment.
Arm Title
Hypnosis + Standard Treatment
Arm Type
Experimental
Arm Description
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment.
Intervention Type
Drug
Intervention Name(s)
immunosuppressor/TNFalpha
Intervention Description
Standard Treatment : immunosuppressor/TNFalpha as in standard practice
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
8 hypnosis group sessions during 2 months
Primary Outcome Measure Information:
Title
Mid term hypnosis efficacy with IBDQ
Description
Efficacy evaluation of hypnosis 6 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Short term hypnosis efficacy with IBDQ
Description
Efficacy evaluation of hypnosis 3 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
3 months
Title
Disease acceptance with ICQ-18
Description
Impact of hypnosis on the disease acceptance short and mid term with the Evolution of the Illness Cognition Questionnaire for chronic disease
Time Frame
3 months and 6 months
Title
Clinical score with Harvey-Bradshaw Index short and mid term
Description
Evolution of the clinical score short and mid term with Harvey-Bradshaw Index
Time Frame
3 months and 6 months
Title
Vagal tonus with electrocardiogram
Description
Evolution of the vagal tonus with electrocardiogram short and mid term
Time Frame
3 months and 6 months
Title
Inflammatory status with C Reactive Protein
Description
Evolution of the C Reactive Protein concentration in the plasma
Time Frame
3 months and 6 months
Title
Stress with Perceived Stress Scale
Description
Evolution of stress status short and mid term with Perceived Stress Scale which goes from 10 to 50. Lower values represent better outcome.
Time Frame
3 months and 6 months
Title
Fatigue with Multidimensional Fatigue Inventory
Description
Evolution of fatigue status short and mid term
Time Frame
3 months and 6 months
Title
Long term hypnosis efficacy
Description
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.
Time Frame
12 months
Title
Clinical score with Harvey-Bradshaw Index long term
Description
Evolution of the clinical score long term with Harvey-Bradshaw Index
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno BONAZ, PU-PH
Phone
04 76 76 55 97
Email
BBonaz@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GONNET
Email
NGonnet@chu-grenoble.fr
Facility Information:
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno BONAZ
Email
BBonaz@chu-grenoble.fr

12. IPD Sharing Statement

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

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