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

COEN Matteo

Status: Begins enrollment this month

Conditions: Post Intensive Care Syndrome (PICS)

Treatments: Other: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT07254299

2025-00369

Details and patient eligibility

About

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.

Full description

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- and 6- 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 and six 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 and six 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 and 6 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

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• On Mechanical Ventilation for at least 48 hours
• Able to give informed consent as documented by signature
• French speaking

Exclusion criteria

• 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
• Patient presenting with delirium (detected by CAM-ICU) on ICU discharge
• Patient hospitalized for brain injury
• Patient is in jail
• Patients already enrolled in the ongoing Nutriphyt trial
• Patient hospitalized for more than 28 days in the ICU

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

Hypnosis group

Experimental group

Description:

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.

Treatment:

Other: Hypnosis

Control group

No Intervention group

Description:

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.