NCT04909970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
3.9 years until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2025

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

May 3, 2021

Last Update Submit

March 11, 2026

Conditions

Keywords

Family caregiversAged personshomebound personsChronic stressSelf-hypnosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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 Outcomes (10)

  • Comparison of the variation in caregiver burden between inclusion and the end of self-hypnosis practice between the 2 groups of participant

    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

    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

    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

    week 16 after enrollment

  • Comparison between the 2 groups the care consumption between inclusion and the end of self-hypnosis practice

    week 16 after enrollment

  • +5 more secondary outcomes

Study Arms (2)

Self hypnosis

EXPERIMENTAL

Self-hypnosis program associated to usual practice of stress management

Other: Self-hypnosis

control group (waiting list)

OTHER

Usual practice of stress management. This group will practice self-hypnosis after the intervention group has practiced self-hypnosis (waiting list).

Other: Control (Waiting list)

Interventions

Self-hypnosis training during 8 weeks and one daily self-hypnosis session during 8 weeks

Self hypnosis

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

control group (waiting list)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de La Réunion

Saint-Pierre, Reunion

Location

Related Publications (1)

  • Reynaud D, Bruneau L. Feasibility and acceptance of self-hypnosis to reduce chronic stress levels on family in-home caregivers of elderly people: protocol for the POSSAID pilot, randomised, wait-list controlled trial. BMJ Open. 2022 Dec 30;12(12):e066749. doi: 10.1136/bmjopen-2022-066749.

MeSH Terms

Interventions

HypnosisWaiting Lists

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Danielle Reynaud

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: waiting list
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

June 2, 2021

Study Start

April 10, 2025

Primary Completion

November 27, 2025

Study Completion

November 27, 2025

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations