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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05760014
Other study ID # 2022_0670
Secondary ID 2022-A02406-37
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2023
Est. completion date December 2023

Study information

Verified date March 2023
Source University Hospital, Lille
Contact Meryem-Maud FARHAT, MD
Phone 0320445962
Email meryem.farhat@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with chronic diseases, especially rare diseases with uncertain diagnoses, have a representation of their disease and an experience of their hospitalization that is sometimes traumatic, distressing and painful. Patients hospitalized can benefit from non-medicinal techniques, such as medical hypnosis, which could improve the perceived stress in these patients and thus optimize the hospitalization experience. The aim of this study is to evaluate the impact of medical hypnosis in reducing stress and improving the experience of hospitalization comparing two groups : a group (cases) benefiting from an hypnotic technic " the place of safety " and a control group without intervention during hospitalization


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients hospitalised in the internal medicine department of the Lille University Hospital - Age>= 18 years - Patients having expressed their non opposition Exclusion Criteria: - Not covered by the social security system - Person unable to receive informed information - Persons deprived of liberty - Persons under legal protection (guardianship / curatorship) - Psychotic and/or dementia disorders - Pregnant and breastfeeding women

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Outcome

Type Measure Description Time frame Safety issue
Primary STAI questionnaire dimension STAI completed at discharge. STAI-ETAT At discharge, an average 10 days
Secondary The STAI ETAT (the current emotional state) questionnaire State Trait Anxiety Inventory Etat - Trait (40 questions - each item has a score from 1 to 4 (4 being the highest level of anxiety)) at baseline and at discharge, an average 10 days
Secondary The STAI-TRAIT (the usual emotional state ) questionnaire State-Trait Anxiety Inventory (STAI-TRAIT) SCORE: 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety at baseline and at discharge, an average 10 days
Secondary patient opinion questionnaire At discharge, an average 10 days
Secondary The difference in STAI STATUS score between the questionnaire completed post-hypnotic treatment and the questionnaire at admission At discharge, an average 10 days
Secondary The ordinal severity scale correlated with the STAI ETAT questionnaire score; At discharge, an average 10 days
Secondary Self-rated stress scale correlated with the STAI ETAT questionnaire score. At discharge, an average 10 days
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