About this trial
The goal of this clinical trial is to evaluate the effectiveness of a hypnosis intervention in improving well-being at day 28 of an ICU stay. The main question it aims to answer is :
-Does Hypnosis intervention at ICU discharge and on day 7 and 14 on the wards if the patient remains in the hospital, improve wellbeing at 28 days ?
Researchers will compare discharged ICU patients who received standard post-discharge care to discharged ICU patients who received standard post-discharge care and hypnosis intervention on discharge and 7 and 14days after if they are still in the hospital, to see if hypnosis can improve their wellbeing.
Participants will receive a hypnosis session on the day of ICU discharge, a second session seven days post-discharge and a third session at day 14 if they are still in the hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
On Mechanical Ventilation for at least 2 days
Able to give informed consent as documented by signature
French speaking
Disqualifiers
Refusal of the patient
Patient transferred from another ICU
Patient is planned for a withdrawal of care or is actively dying
Glasgow coma scale (GCS) <15 on ICU discharge
Trial design
Parallel
Treatments tested in this trial
Hypnosis
Other interventionthe hypnosis will be tailored to each patient. Key elements will include relaxation (to mitigate anxiety and stress and help the patient feel more comfortable, secure, and competent), reassociation techniques (to help the patient reconnect with their body, promoting a sense of embodiment and presence), and safe place (to introduce a safe and calming place to instill a sense of control and competence, aiding in emotional stabilization and fostering a sense of safety and well-being).
Treatment groups
Trial outcomes
Primary outcomes
Wellbeing at day 28 post intensive care unit discharge
ESAS scale (Edmonton Symptom Assessment System) with a range from 0 to 100. Higher scores means worse wellbeing.
Secondary outcomes
Immediate wellbeing following a hypnosis session
1\) ESAS scale before and after the hypnosis session performed on Day 1 (ICU discharge), Day 7 and D14 -The ESAS scale (Edmonton Symptom Assessment System) has a range from 0 to 100.
PDI - Peritraumatic distress inventory
PDI (Peritraumatic distress index, range: 13-65)
PHQ-9 - Patient Health Questionnaire-9
PHQ-9 (Patient Health Questionnaire-9: range 0-27) will be used to assess depressive symptoms at day 28 and 3 months
GAD-7 - Generalized Anxiety Disorder-7
GAD-7 (Generalized Anxiety Disorder-7, range 0-21) will be used to assess anxiety symptoms at day 28 and 3 months post ICU discharge
Sponsors and contacts
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COEN Matteo
Lead sponsor
University Hospital, Geneva
Sponsor institution