Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
HYPNOCROHN
1 other identifier
interventional
40
1 country
1
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;
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
November 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2021
CompletedMarch 23, 2020
March 1, 2020
3 years
July 4, 2018
March 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
6 months
Secondary Outcomes (9)
Short term hypnosis efficacy with IBDQ
3 months
Disease acceptance with ICQ-18
3 months and 6 months
Clinical score with Harvey-Bradshaw Index short and mid term
3 months and 6 months
Vagal tonus with electrocardiogram
3 months and 6 months
Inflammatory status with C Reactive Protein
3 months and 6 months
- +4 more secondary outcomes
Study Arms (2)
immunosuppressor/TNFalpha
ACTIVE COMPARATORStandard treatment with immunosuppressor and/or anti-TNFalpha treatment.
Hypnosis + Standard Treatment
EXPERIMENTALStandard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment.
Interventions
Standard Treatment : immunosuppressor/TNFalpha as in standard practice
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Person under legal protection (articles L1121-5 and L1121-8 of Public health code)
- Hypnosis contraindication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Grenoble, 38000, France
Related Publications (1)
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2018
First Posted
August 9, 2018
Study Start
November 13, 2018
Primary Completion
November 12, 2021
Study Completion
November 13, 2021
Last Updated
March 23, 2020
Record last verified: 2020-03