NCT07254299

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

November 14, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

post intensive care syndromerandomized controlled trailhypnosis

Outcome Measures

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.

    Day 28 post intensive care unit discharge

Secondary Outcomes (7)

  • Immediate wellbeing following a hypnosis session

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

  • PDI - Peritraumatic distress inventory

    day 28 post ICU discharge

  • PHQ-9 - Patient Health Questionnaire-9

    Day 28 post intensive care unit discharge and 3 months post intensive care

  • GAD-7 - Generalized Anxiety Disorder-7

    at day 28 and 3 months post ICU discharge

  • IES-R (Impact of event Scale)

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

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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).

Hypnosis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On Mechanical Ventilation for at least 2 days
  • Able to give informed consent as documented by signature
  • French speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Geneva

Geneva, 1205, Switzerland

RECRUITING

Hôpitaux Neuchâtelois

Neuchâtel, Switzerland

NOT YET RECRUITING

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

postintensive care syndrome

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hannah Wozniak, Medical Doctor

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR
  • Matteo Coen, MD, PHD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Wozniak, Medical Doctor

CONTACT

Jennifer B. C. S Muradbegovic, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med. PD. PhD

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 28, 2025

Study Start

March 16, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations