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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Intensive Care Syndrome (PICS)
• Intervention / Treatment: Other: Hypnosis

Detailed 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-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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Wozniak, Medical Doctor; Phone Number: +41; Email: hannah-wozniak@hug.ch
• Study Contact Backup: Name: Jennifer B. C. S Muradbegovic, Doctor; Phone Number: +41 79 55 36255; Email: jennifer.cau@hug.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • University Hospital of Geneva
    • Contact: Hannah Wozniak, Medical Doctor; Phone Number: +41; Email: hannah-wozniak@hug.ch
    • Contact: Jennifer Muradbegovic, Doctor; Phone Number: +41 79 55 36255; Email: jennifer.cau@hug.ch
  • Neuchâtel, Switzerland
    • Not yet recruiting
    • Hôpitaux Neuchâtelois
    • Contact: Marie-Eve Brunner, Medical Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• On Mechanical Ventilation for at least 2 days
• 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 traumatic brain injury
• Patient is in jail
• Patient hospitalized for more than 28 days in the ICU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis group; 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; 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).
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28 post intensive care unit discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (Day of discharge from ICU), day 7, day 14
PDI - Peritraumatic distress inventory	PDI (Peritraumatic distress index, range: 13-65)	day 28 post ICU discharge
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	Day 28 post intensive care unit discharge and 3 months post intensive care
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	at day 28 and 3 months post ICU discharge
IES-R (Impact of event Scale)	Range: 0-88	3 months post intensive care unit discharge. Higher score means more PTSD symptoms.
EQ-5D-5L (Quality of life)	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.	Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
PGIC - Patient Global Impression of Change	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	Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge

Collaborators and Investigators

• Sponsor: COEN Matteo
• Investigators: Principal Investigator: Hannah Wozniak, Medical Doctor, University Hospital, Geneva; Principal Investigator: Matteo Coen, MD, PHD, University Hospital, Geneva

Publications and helpful links

General Publications

• Schmidt B, Schneider J, Deffner T, Rosendahl J. Hypnotic suggestions of safety improve well-being in non-invasively ventilated patients in the intensive care unit. Intensive Care Med. 2021 Apr;47(4):485-486. doi: 10.1007/s00134-021-06364-8. Epub 2021 Feb 16. No abstract available.
• Spiegel D, Cardena E. New uses of hypnosis in the treatment of posttraumatic stress disorder. J Clin Psychiatry. 1990 Oct;51 Suppl:39-43; discussion 44-6.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hypnosis; randomized controlled trail; post intensive care syndrome
• Additional Relevant MeSH Terms: postintensive care syndrome; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis
• Other Study ID Numbers: 2025-00369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No