NCT05760014

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2024

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

February 24, 2023

Last Update Submit

December 18, 2025

Conditions

Keywords

hypnosisperceived stressplace of safetycase control study

Outcome Measures

Primary Outcomes (1)

  • STAI questionnaire dimension STAI completed at discharge.

    STAI-ETAT

    At discharge, an average 10 days

Secondary Outcomes (6)

  • The STAI ETAT (the current emotional state) questionnaire

    at baseline and at discharge, an average 10 days

  • The STAI-TRAIT (the usual emotional state ) questionnaire

    at baseline and at discharge, an average 10 days

  • patient opinion questionnaire

    At discharge, an average 10 days

  • The difference in STAI STATUS score between the questionnaire completed post-hypnotic treatment and the questionnaire at admission

    At discharge, an average 10 days

  • The ordinal severity scale correlated with the STAI ETAT questionnaire score;

    At discharge, an average 10 days

  • +1 more secondary outcomes

Study Arms (2)

CAS patients

CAS patients with a conventional follow-up who will benefit from the hypnosis technique known as "Place of Safety" on their admission to conventional hospitalization.

TEMOINS patients

TEMOINS patients with conventional follow-up who will not benefit from the medical hypnosis technique.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalised for their chronic illness

You may qualify if:

  • Patients hospitalised in the internal medicine department of the Lille University Hospital
  • Age\>= 18 years
  • Patients having expressed their non opposition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

service de médecine interne CHU Lille

Lille, France

Location

Study Officials

  • Mereym-Maud FAHRAT, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 8, 2023

Study Start

March 28, 2023

Primary Completion

February 9, 2024

Study Completion

February 9, 2024

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations