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

Crohn Disease Clinical Trial

— HYPNOCROHN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623932
• Other study ID #: 38RC17.298
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: November 13, 2021

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: Bruno BONAZ, PU-PH
• Phone: 04 76 76 55 97
• Email: BBonaz[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 13, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• immunosuppressor/TNFalpha
Standard Treatment : immunosuppressor/TNFalpha as in standard practice

Behavioral:
• Hypnosis
8 hypnosis group sessions during 2 months

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	3 months
Secondary	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	3 months and 6 months
Secondary	Clinical score with Harvey-Bradshaw Index short and mid term	Evolution of the clinical score short and mid term with Harvey-Bradshaw Index	3 months and 6 months
Secondary	Vagal tonus with electrocardiogram	Evolution of the vagal tonus with electrocardiogram short and mid term	3 months and 6 months
Secondary	Inflammatory status with C Reactive Protein	Evolution of the C Reactive Protein concentration in the plasma	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	Fatigue with Multidimensional Fatigue Inventory	Evolution of fatigue status short and mid term	3 months and 6 months
Secondary	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.	12 months
Secondary	Clinical score with Harvey-Bradshaw Index long term	Evolution of the clinical score long term with Harvey-Bradshaw Index	12 months