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Clinical Trials/NCT04909970
NCT04909970CompletedNot Applicable

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

Centre Hospitalier Universitaire de la Réunion1 site in 1 country14 target enrollmentStarted: April 10, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Self hypnosis

Experimental

Self-hypnosis program associated to usual practice of stress management

Intervention: Self-hypnosis (Other)

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).

Intervention: Control (Waiting list) (Other)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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 quality of life 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 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 sleep quality between inclusion and the end of selfhypnosis 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)
  • Comparison of the variation of perceived stress between inclusion and the end of self-hypnosis practice between the 2 groups of participant(week 16 after enrollment)
  • Observance of self-hypnosis sessions at home(week 32 after enrollment)
  • Observance of self-hypnosis sessions at home(week 8 after enrollment)
  • Observance of self-hypnosis sessions at home(week 16 after enrollment)

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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