StressPOSSAIDNCT04909970
Impact of a Self-hyPnOsis Practice on Chronic StresS Among Caregivers of Elderly People With Loss of Autonomy at Home
A study testing Self-hypnosis in people with Stress, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Self-hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteReunion
- Study dates
- 10 Apr 2025to 27 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Stress
- Being tested
- Self-hypnosis, Control (Waiting list)
- Keywords
- Family caregivers, Aged persons, homebound persons, Chronic stress, Self-hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosisOther
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
| Study group | Role | What they receive |
|---|---|---|
| Self hypnosis | Experimental | Self-hypnosis program associated to usual practice of stress management Receives: 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). Receives: Other: Control (Waiting list) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The burden will be evaluated by the Zarit scale min score = 0 and max score =88 score>60 = serious burden
Measured: 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
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
Measured: 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
The level of fatigue will be evaluated by the Pichot scale
Measured: 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
Quality of life will be evaluated by the SF-12 scale Score calculated with a software
Measured: week 16 after enrollment
Comparison between the 2 groups the care consumption between inclusion and the end of self-hypnosis practice
The care consumption will collected on a patient diary.
Measured: week 16 after enrollment
Observance of self-hypnosis sessions at home
Duration and localization of the session will be collected on a patient diary.
Measured: week 8 after enrollment
Observance of self-hypnosis sessions at home
Duration and localization of the session will be collected on a patient diary.
Measured: week 16 after enrollment
Observance of self-hypnosis sessions at home
Duration of the session will be collected on a patient diary.
Measured: week 32 after enrollment
Observance of self-hypnosis sessions at home
Localization of the session will be collected on a patient diary.
Measured: week 32 after enrollment
Comparison of the variation of perceived stress between inclusion and the end of self-hypnosis practice between the 2 groups of participant
Stress will be evaluated by the Perceived Stress Scale (PSS) min score = 10 and max score = 50 score < 27 : stress management by the person
Measured: week 16 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start10 Apr 2025
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- waiting list
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Reynaud, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909970
- Sponsor's protocol ID
- 2021/CHU/02
- Acronym
- POSSAID
- Status last verified
- Mar 2026
- First submitted
- 3 May 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36585135
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04909970
- Acronym / sponsor ID
- POSSAID / 2021/CHU/02
- Conditions
- Stress
- Keywords
- Family caregivers, Aged persons, homebound persons, Chronic stress, Self-hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- waiting list
| Arm | Type | Receives |
|---|---|---|
| Self hypnosis | Experimental | Other: Self-hypnosisSelf-hypnosis program associated to usual practice of stress management |
| control group (waiting list) | Other | Other: Control (Waiting list)Usual practice of stress management. This group will practice self-hypnosis after the intervention group has practiced self-hypnosis (waiting list). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-hypnosisSelf-hypnosis training during 8 weeks and one daily self-hypnosis session during 8 weeks | Other | Self hypnosis |
| 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 | Other | control group (waiting list) |
Primary outcome
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.
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.
10 secondary outcomes
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
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
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
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
Comparison between the 2 groups the care consumption between inclusion and the end of self-hypnosis practice
Time frame: week 16 after enrollment
Observance of self-hypnosis sessions at home
Time frame: week 8 after enrollment
Observance of self-hypnosis sessions at home
Time frame: week 16 after enrollment
Observance of self-hypnosis sessions at home
Time frame: week 32 after enrollment
Observance of self-hypnosis sessions at home
Time frame: week 32 after enrollment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 36585135Reynaud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Reynaud principal investigator
CHU de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnosis in people with Stress, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: week 16 after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.