Hypnosis to Improve Well-beings of Critically Ill Patients and Prevent Post-intensive Care Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCOEN Matteo

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hypnosis

    Other intervention

    the 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

150 Participants
are divided into 2 treatment groups
Group A: Hypnosis groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 28 post intensive care unit discharge

Secondary outcomes

1

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.

Time frame
Day 1 (Day of discharge from ICU), day 7, day 14
2

PDI - Peritraumatic distress inventory

PDI (Peritraumatic distress index, range: 13-65)

Time frame
day 28 post ICU discharge
3

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

Time frame
Day 28 post intensive care unit discharge and 3 months post intensive care
4

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

Time frame
at day 28 and 3 months post ICU discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

COEN Matteo

Lead sponsor

University Hospital, Geneva

Sponsor institution