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

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04909970
Collaborator
(none)
60
2
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Self-hypnosis
  • Other: Control (Waiting list)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
waiting listwaiting list
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Self hypnosis

Self-hypnosis program associated to usual practice of stress management

Other: Self-hypnosis
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).

Other: Control (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

Outcome Measures

Primary Outcome Measures

  1. 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]

    Stress will be evaluated by the Perceived Stress Scale (PSS) min score = 10 and max score = 50 score < 27 : stress management by the person

Secondary Outcome Measures

  1. 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]

    The burden will be evaluated by the Zarit scale min score = 0 and max score =88 score>60 = serious burden

  2. 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]

    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

  3. 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]

    The level of fatigue will be evaluated by the Pichot scale

  4. 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]

    Quality of life will be evaluated by the SF-12 scale Score calculated with a software

  5. Comparison between the 2 groups the care consumption between inclusion and the end of self-hypnosis practice [week 16 after enrollment]

    The care consumption will collected on a patient diary.

  6. Observance of self-hypnosis sessions at home [week 8 after enrollment]

    Duration and localization of the session will be collected on a patient diary.

  7. Observance of self-hypnosis sessions at home [week 16 after enrollment]

    Duration and localization of the session will be collected on a patient diary.

  8. Observance of self-hypnosis sessions at home [week 32 after enrollment]

    Duration of the session will be collected on a patient diary.

  9. Observance of self-hypnosis sessions at home [week 32 after enrollment]

    Localization of the session will be collected on a patient diary.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Danielle Reynaud, CHU de La Réunion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT04909970
Other Study ID Numbers:
  • 2021/CHU/02
First Posted:
Jun 2, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de la Réunion

Study Results

No Results Posted as of Mar 31, 2022