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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03623932
• Date of registration: 04/07/2018
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Grenoble
• Public title: Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease HYPNOCROHN
• Scientific title: Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
• Date of first enrolment: November 13, 2018
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03623932
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Bruno BONAZ

• Name: Bruno BONAZ, PU-PH

Key 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: immunosuppressor/TNFalpha

Behavioral: Hypnosis

Primary Outcome(s)

Mid term hypnosis efficacy with IBDQ [Time Frame: 6 months]

Secondary Outcome(s)

Disease acceptance with ICQ-18 [Time Frame: 3 months and 6 months]

Stress with Perceived Stress Scale [Time Frame: 3 months and 6 months]

Vagal tonus with electrocardiogram [Time Frame: 3 months and 6 months]

Long term hypnosis efficacy [Time Frame: 12 months]

Clinical score with Harvey-Bradshaw Index long term [Time Frame: 12 months]

Inflammatory status with C Reactive Protein [Time Frame: 3 months and 6 months]

Short term hypnosis efficacy with IBDQ [Time Frame: 3 months]

Fatigue with Multidimensional Fatigue Inventory [Time Frame: 3 months and 6 months]

Clinical score with Harvey-Bradshaw Index short and mid term [Time Frame: 3 months and 6 months]

Secondary ID(s)

38RC17.298

Source(s) of Monetary Support

Please refer to primary and secondary sponsors