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

Introduction: Family members who care for elderly people experience high levels of chronic stress because of the intensive assistance they provide permanently to those who are losing their autonomy. Often considered a burden, this stress causes serious consequences to their health and worsens their quality of life (QoL). Reducing caregivers' chronic stress via self-hypnosis protocols may be an effective treatment. The objective is to evaluate the feasibility and acceptance of self-hypnosis protocols taught by hypnotherapy-trained nurses to reduce the chronic stress of in-family caregivers.

Methods and analysis: This study is a prospective, monocentric, non-blinded, parallel, pilot, randomised waitlist-controlled trial that will be conducted at the University Hospital of Reunion Island. Sixty participants will be randomly allocated to one of two groups: a self-hypnosis group (intervention) or a waitlist control group. After an 8-week training programme, intervention participants will practice self-hypnosis for ten minutes/day over 8 weeks and subsequently be followed up for 16 weeks thereafter. The primary outcome is to assess the feasibility of a 16-week self-hypnosis protocol for in-family caregivers. Secondary outcomes include the evaluation of the effects of practising self-hypnosis among in-family caregivers of elderly people concerning their stress levels, sleep disorders, levels of fatigue, and QoL at 2, 4 and 8 months on an exploratory basis.

Ethics and dissemination: Ethics approval was obtained from the Institutional Ethics Committee CPP Ile de France VI-Groupe Hospitalier Pitié Salpêtrière on 14 April 2021 (ID RCB: 2021-A00009-32). All participants will receive information about the trial in verbal and written forms. They will give an oral consent which is notified in a dedicated research file prior before enrolment. Results will be published in peer-reviewed journals as well as presented and disseminated at conferences.

Trial registration number: NCT04909970.