Impact of a Self-hyPnOsis Practice on Chronic StresS Among Caregivers of Elderly People With Loss of Autonomy at Home (POSSAID)

Impact of a Self-hyPnOsis Practice on Chronic StresS Among Caregivers of Elderly People With Loss of Autonomy at Home: a Randomized Controlled Pilot Study With a Waiting List

In France, stress particularly affects family caregivers because of the intensive help they provide on a permanent basis to people losing their autonomy at home. This care work is often considered as a "burden" and has all the characteristics of a chronic daily stress factor. The prevalence of stress among caregivers is high and the level of stress varies according to the type of care provided to seniors at home.

This chronic stress has harmful effects on the health of family caregivers (depression, fatigue, insomnia, onset of chronic diseases, early mortality). It can be detrimental to their well-being and quality of life.

However, ageing well at home for older people is based on this essential pillar: the caregivers. They must remain in good physical and psychological health. Reducing their daily stress is becoming a public health challenge and a national priority.

Currently, the management of caregiver stress is based on several measures and devices. Non-conventional care practices such as Mindfulness-Based Stress Reduction, meditation, relaxation and yoga are offered to family caregivers. Initial results of studies on the effect of these complementary medicines show an improvement in psychological stress. However, research in this field is relatively recent. The conclusions must therefore be approached with caution. Moreover, no medium or long-term evaluation has been found in the scientific literature.

Self-hypnosis is becoming a common practice in healthcare. It has demonstrated its effectiveness in reducing pain and anxiety in both adults and children. In addition, other recent scientific evidence supports the effectiveness of hypnosis in stress management. In France, no study on caregiver stress and its management by self-hypnosis has been identified in the literature. The hypothesis is that the stress level of caregivers of elderly people at home could be reduced through daily self-hypnosis practice at home.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-Pierre, Reunion
        • CHU de la réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Stress > or = 3 evaluated by the analogic visual scale of CHAMOUX
  • Caregiver at home for a person uper than 60 years old with a loss of autonomy and followed in geriatrics or in polyvalent medicine
  • Daily help in at least one of the 3 spheres of the elderly activity
  • Person providing care services for more than 2 years with the elderly
  • Person who can read and write
  • Person affiliated to a social security scheme
  • Person who gives his oral express consent
  • Person who lives in Reunion Island

Exclusion Criteria:

  • Person with serious chronic disorder (cancer for example)
  • Person with a contraindication to hypnosis (cognitive and psychiatric disorders or alcohol dependence)
  • Person under specific treatment preventing them from performing the intervention consistently
  • Person who has already practiced hypnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self hypnosis
Self-hypnosis program associated to usual practice of stress management
Self-hypnosis training during 8 weeks and one daily self-hypnosis session during 8 weeks
Other: control group (waiting list)
Usual practice of stress management. This group will practice self-hypnosis after the intervention group has practiced self-hypnosis (waiting list).
Usual practice during the first 16 weeks. At the end of study, the participant will practice Self-hypnosis training during 8 weeks and one daily self-hypnosis session during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the feasibility of a practice of self-hypnosis on reducing the stress of carers caring for the elderly at home compared to a control group with waiting list.
Time Frame: week 16 after enrollment

Membership of program participants : number of session of self-hypnosis realized compared to proposed session.

It will be considered sufficient if 80% of the participants carry out 2 individual sessions and 1 collective hypnosis session during the training and practice 80% of the self-hypnosis sessions at home.

week 16 after enrollment
Assessment of the feasibility of a practice of self-hypnosis on reducing the stress of carers caring for the elderly at home compared to a control group with waiting list.
Time Frame: 6 months after the first enrollment
number of patients recruited over 6 months Recruitment will be deemed acceptable if 60 participants are recruited over 6 months.
6 months after the first enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the variation in caregiver burden between inclusion and the end of self-hypnosis practice between the 2 groups of participant
Time Frame: week 16 after enrollment
The burden will be evaluated by the Zarit scale min score = 0 and max score =88 score>60 = serious burden
week 16 after enrollment
Comparison of the variation in caregiver sleep quality between inclusion and the end of selfhypnosis practice between the 2 groups of participant
Time Frame: week 16 after enrollment
The quality of sleep will be evaluated by the Pittsburgh Sleep Quality Index (PSQI) min score = 0 and max score = 32 score = 32 : extreme fatigue
week 16 after enrollment
Comparison of the variation in caregiver fatigue level between inclusion and the end of self-hypnosis practice between the 2 groups of participant
Time Frame: week 16 after enrollment
The level of fatigue will be evaluated by the Pichot scale
week 16 after enrollment
Comparison of the variation in caregiver quality of life between inclusion and the end of self-hypnosis practice between the 2 groups of participant
Time Frame: week 16 after enrollment
Quality of life will be evaluated by the SF-12 scale Score calculated with a software
week 16 after enrollment
Comparison between the 2 groups the care consumption between inclusion and the end of self-hypnosis practice
Time Frame: week 16 after enrollment
The care consumption will collected on a patient diary.
week 16 after enrollment
Observance of self-hypnosis sessions at home
Time Frame: week 8 after enrollment
Duration and localization of the session will be collected on a patient diary.
week 8 after enrollment
Observance of self-hypnosis sessions at home
Time Frame: week 16 after enrollment
Duration and localization of the session will be collected on a patient diary.
week 16 after enrollment
Observance of self-hypnosis sessions at home
Time Frame: week 32 after enrollment
Duration of the session will be collected on a patient diary.
week 32 after enrollment
Observance of self-hypnosis sessions at home
Time Frame: week 32 after enrollment
Localization of the session will be collected on a patient diary.
week 32 after enrollment
Comparison of the variation of perceived stress between inclusion and the end of self-hypnosis practice between the 2 groups of participant
Time Frame: week 16 after enrollment
Stress will be evaluated by the Perceived Stress Scale (PSS) min score = 10 and max score = 50 score < 27 : stress management by the person
week 16 after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Danielle Reynaud, CHU de la réunion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Actual)

November 27, 2025

Study Completion (Actual)

November 27, 2025

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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