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

Critically ill patients in the Intensive Care Unit (ICU) face numerous challenges both acutely and in the long term. These patients frequently experience acute pain and anxiety due to intubation and induced comas. Following their ICU discharge, they commonly report decreased well-being and quality of life. Additionally, up to 40% of critically ill patients develop post-intensive care syndrome (PICS), which includes mental, physical, and cognitive sequelae that can persist up to one year after discharge. Heavy sedation and medications necessary to manage pain and anxiety are known risk factors for PICS.

The current standard of care in the ICU includes mobilization and nutrition, pain control, and family engagement and empowerment. Furthermore, no other specific interventions are aimed at improving long-term outcomes and preventing PICS.

Several studies have explored using hypnosis to improve the acute care of ICU patients. For instance, a pain protocol that included hypnosis in burn patients hospitalized in the CHUV (Centre Hospitalier Universitaire Vaudois) resulted in reduced pain intensity, reduced opioid use, reduced anxiety, and better wound outcomes, all while lowering costs. A pilot study involving non-invasive ventilation patients showed that hypnosis could improve comfort, mask tolerance, and anxiety levels. Additionally, studies on relaxation therapy have indicated that electronic relaxation therapy is a promising, safe, and effective non-pharmacological solution to enhance overall comfort in alert and non-delirious ICU patients.

However, despite these efforts, there is a lack of efficient interventions specifically targeting the wellbeing of patients after an ICU stay and the prevention of PICS. Existing interventions, such as follow-up programs, rehabilitation, and psychological follow-up, have shown conflicting results. To date, no studies have specifically assessed the effect of hypnosis on the short and longer-term well-being of critically ill patients leaving the ICU and its possible effect on the prevention of PICS.

The investigators hypothesize that providing a hypnosis session at ICU discharge and followed by subsequent sessions on days 7 and 14 on the ward will improve well-being in the short term and reduce PICS symptoms at 3-months. The primary outcome will be the assessment of well-being at day 28 post-ICU discharge. Secondary outcomes will be anxiety, depression, PTSD, and quality of life at three months.

Hypothesis and primary objective The investigators hypothesize that providing intervention with hypnosis at ICU discharge and subsequent sessions on day 7 and 14 on the ward if the patient remains in the hospital will improve wellbeing at day 28 and reduce PICS symptoms at three months in critically ill patients.

Primary Objective:

The primary objective of this study is to evaluate the effectiveness of a hypnosis intervention in improving well-being at day 28 of an ICU stay.

Scale used for wellbeing:

• ESAS, total 90, each item on a 0-10 scale
• EQ-5D-5L

Secondary Objectives:

1. To assess the impact of a hypnosis intervention to improve PICS at 3 months

* Anxiety and depression: PHQ-9 et GAD-7
* Post-traumatic stress disorder: PDI and IES-R scale
* Quality of life: SF-12, EQ-5D-5L and WHODAS 2.0
* Patient impression of change: PGIC
2. To evaluate patient immediate wellbeing after the hypnosis intervention. • ESAS before after the session in patients who will get the session

Participants in the intervention group will receive a hypnosis session on the day of discharge, a second session seven days post-discharge, and a third session on day 14 if they are still in the hospital. Trained professionals will conduct the hypnosis sessions following a standardized protocol, designed by the study team for critically ill patients.

Other: Hypnosis

Participants in the control group will receive standard post-discharge care, which includes mobilization, nutrition, pain control, and family engagement and empowerment, without any hypnosis 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).

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

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 28 post ICU discharge

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

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

PHQ-9 (Patient Health Questionnaire-9: range 0-27) will be used to assess depressive symptoms at day 28 and 3 months

Time frame: at day 28 and 3 months post ICU discharge

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: 3 months post intensive care unit discharge. Higher score means more PTSD symptoms.

Range: 0-88

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

Part 1) 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. The 5-digit health state is converted (via country-specific value set) to an index value

Part 2) EQ VAS (Visual Analog Scale). Patient rates their health today from 0 to 100.

Higher scores mean better quality of life.

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

Single-item global rating of how much the patient feels their condition has changed since a reference time. Higher scores means improvement.

Scoring / range: 1-7

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