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Completed

NCT Number: NCT04909970

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de La Réunion

Saint-Pierre, Reunion

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-hypnosis

Other

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

Control (Waiting list)

Other

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

Primary outcomes

  1. 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.

  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.

    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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  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

    Time frame: 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

    Time frame: week 16 after enrollment

    The care consumption will collected on a patient diary.

  6. 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.

  7. 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.

  8. Observance of self-hypnosis sessions at home

    Time frame: week 32 after enrollment

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

  9. Observance of self-hypnosis sessions at home

    Time frame: week 32 after enrollment

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

  10. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study 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

Acronym: POSSAID

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2021
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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