Clinical trial NCT04909970: Impact of a Self-hyPnOsis Practice on Chronic StresS Among Caregivers of Elderly People With Loss of Autonomy at Home
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Keywords: Family caregivers
Aged persons
homebound persons
Chronic stress
Self-hypnosis
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: waiting list
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: week 16 after enrollment
measure: 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.
timeFrame: 6 months after the first enrollment
Secondary outcomes:
measure: Comparison of the variation in caregiver burden between inclusion and the end of self-hypnosis practice between the 2 groups of participant
timeFrame: week 16 after enrollment
measure: Comparison of the variation in caregiver sleep quality between inclusion and the end of selfhypnosis practice between the 2 groups of participant
timeFrame: week 16 after enrollment
measure: Comparison of the variation in caregiver fatigue level between inclusion and the end of self-hypnosis practice between the 2 groups of participant
timeFrame: week 16 after enrollment
measure: Comparison of the variation in caregiver quality of life between inclusion and the end of self-hypnosis practice between the 2 groups of participant
timeFrame: week 16 after enrollment
measure: Comparison between the 2 groups the care consumption between inclusion and the end of self-hypnosis practice
timeFrame: week 16 after enrollment
measure: Observance of self-hypnosis sessions at home
timeFrame: week 8 after enrollment
measure: Observance of self-hypnosis sessions at home
timeFrame: week 16 after enrollment
measure: Observance of self-hypnosis sessions at home
timeFrame: week 32 after enrollment
measure: Observance of self-hypnosis sessions at home
timeFrame: week 32 after enrollment
measure: Comparison of the variation of perceived stress between inclusion and the end of self-hypnosis practice between the 2 groups of participant
timeFrame: week 16 after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: CHU de La Réunion
name: Danielle Reynaud
role: PRINCIPAL_INVESTIGATOR
References: