Post Intensive Care Syndrome (PICS)HypnoPICSNCT07254299
Hypnosis to Improve Well-beings of Critically Ill Patients and Prevent Post-intensive Care Syndrome
A study testing Hypnosis in people with Post Intensive Care Syndrome (PICS), run by COEN Matteo at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome (PICS)
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 16 Mar 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On Mechanical Ventilation for at least 2 days
- Able to give informed consent as documented by signature
- French speaking
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital of Geneva
Geneva, 1205
Hannah Wozniak, Medical Doctor, +41, hannah-wozniak@hug.ch
Jennifer Muradbegovic, Doctor, +41 79 55 36255, jennifer.cau@hug.ch
- Not yet recruiting
Hôpitaux Neuchâtelois
Neuchâtel
Marie-Eve Brunner, Medical Doctor
About this study
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 ?
Read more
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.
Read the 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:
- 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
- To evaluate patient immediate wellbeing after the hypnosis intervention. • ESAS before after the session in patients who will get the session
- Conditions
- Post Intensive Care Syndrome (PICS)
- Being tested
- Hypnosis
- Keywords
- post intensive care syndrome, randomized controlled trail, hypnosis
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis group | Experimental | 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. Receives: Other: Hypnosis |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28 post intensive care unit discharge
Secondary outcomes (7)
Immediate wellbeing following a hypnosis session
- 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.
Measured: Day 1 (Day of discharge from ICU), day 7, day 14
PDI - Peritraumatic distress inventory
PDI (Peritraumatic distress index, range: 13-65)
Measured: 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
Measured: 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
Measured: at day 28 and 3 months post ICU discharge
IES-R (Impact of event Scale)
Range: 0-88
Measured: 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.
Measured: 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
Measured: Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start16 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care Syndrome (PICS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- COEN Matteo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, COEN Matteo, University Hospital, Geneva
- Investigators
- Hannah Wozniak, Medical Doctor, Principal investigator, University Hospital, GenevaMatteo Coen, MD, PHD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254299
- Sponsor's protocol ID
- 2025-00369
- Other IDs
- 2025
- Acronym
- HypnoPICS
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33590259Spiegel 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.
PubMed 2211565
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis to Improve Well-beings of Critically Ill Patients and Prevent Post-intensive Care Syndrome
- ClinicalTrials.gov ID
- NCT07254299
- Acronym / sponsor ID
- HypnoPICS / 2025-00369
- Conditions
- Post Intensive Care Syndrome (PICS)
- Keywords
- post intensive care syndrome, randomized controlled trail, hypnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- COEN MatteoUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- To evaluate patient immediate wellbeing after the hypnosis intervention. • ESAS before after the session in patients who will get the session
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis group | Experimental | Other: HypnosisParticipants 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On Mechanical Ventilation for at least 2 days
- Able to give informed consent as documented by signature
- French speaking
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosisthe 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). | Other | Hypnosis group |
Primary outcome
Wellbeing at day 28 post intensive care unit discharge
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.
7 secondary outcomes
Immediate wellbeing following a hypnosis session
Time frame: Day 1 (Day of discharge from ICU), day 7, day 14
PDI - Peritraumatic distress inventory
Time frame: day 28 post ICU discharge
PHQ-9 - Patient Health Questionnaire-9
Time frame: Day 28 post intensive care unit discharge and 3 months post intensive care
GAD-7 - Generalized Anxiety Disorder-7
Time frame: at day 28 and 3 months post ICU discharge
IES-R (Impact of event Scale)
Time frame: 3 months post intensive care unit discharge. Higher score means more PTSD symptoms.
EQ-5D-5L (Quality of life)
Time frame: Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
PGIC - Patient Global Impression of Change
Time frame: Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 33590259Schmidt 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.
- Results publication: PubMed 2211565Spiegel 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah Wozniak, Medical Doctor principal investigator
University Hospital, Geneva
Matteo Coen, MD, PHD principal investigator
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Post Intensive Care Syndrome (PICS), run by COEN Matteo at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Wozniak, Medical Doctor (+41, hannah-wozniak@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wellbeing at day 28 post intensive care unit discharge (time frame: Day 28 post intensive care unit discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07254299, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.