Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-12

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Admission to a surgical intensive care unit (ICU) following major surgery is associated with a number of discomforts, not only related to the disease itself, but also to the care provided or the ICU environment itself (lights, sounds, pain, sleep deprivation, thirst...). This discomfort is real, and can be associated with psychological consequences. The investigators hypothesized that the use of immersive virtual reality (IVR) with HypnoVR® is feasible and can help reduce discomfort in intensive care.The ZION trial is a prospective, monocentric trial, randomizing 194 patients admitted in a surgical intensive care unit after a major surgery. The inclusion criterion are patients admitted in a surgical intensive care for at least 48 hours following major surgery (cardiac, thoracic or major abdominal surgery). Patients will be allocated to the intervention group (n=97) or the control group (n=97). In the intervention group, patients will receive IVR using HypnoVR®, twice a day, during the ICU stay (2 to 5 days). In the control group, postoperative care will be conducted according to standard cares without IVR. The primary endpoint will be the 18-items IPREA questionnaire on the day of ICU discharge. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnea, thirst and sleep deprivation), incidence of delirium, cumulative morphine consumption at ICU discharge, length of ICU stay, and anxiety or depression at 1 month after discharge from intensive care and patient experience of device use.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementing Virtual Reality in the Operating Room

NCT06333639

General Surgery Orthopedic Procedures

COMPLETED

Virtual Reality to Reduce the Anxiety in Critically Ill Patient

NCT06747793

Anxiety Intensive Care Unit Syndrome

NOT_YET_RECRUITING NA

Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery

NCT07013695

Orthopedic Procedure Anesthesia Sedation

RECRUITING NA

Effect of Virtual Reality Combined With Cycloergometer Versus Conventional Cycloergometer on Distance Covered for Intensive Care Unit Non-sedated Participants

NCT05952180

Intensive Care Unit

COMPLETED NA

Reorganization Strategy to Optimize the Use of Virtual Reality

NCT07132710

Adult Patients Managed in a Cardiac Critical Care Unit With a Pathology Requiring at Least One Potentially Painful and Anxiety-provoking Invasive Procedure

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immersive Virtual Reality Discomfort IPREA Intensive Care Unit Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard group

Group Type ACTIVE_COMPARATOR

usual health care

Intervention Type OTHER

usual health care

intervention group

Group Type EXPERIMENTAL

HypnoVR

Intervention Type DEVICE

In the intervention group, after extubation, patients will receive IVR with HypnoVR®, twice-a-day over two to five days. The product consists of HypnoVR® virtual reality software and HypnoVR® Compagnon remote control software. HypnoVR® is a CE-marked class 1 medical device, developed and marketed by HypnoVR SAS, an ISO 13484:2016 and ISO 27001:2017 certified company. The device works with a virtual reality headset, a personal audio device and a mobile terminal. The investigators will only use sessions of 10 to 20 minutes. For each type of session, a visual universe, a musical atmosphere and a male or female voice are defined. Typically, the scenarios include 3 phases: preparation, hypnosis and return. We will use the following sessions: anxiety, pain, rehabilitation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HypnoVR

In the intervention group, after extubation, patients will receive IVR with HypnoVR®, twice-a-day over two to five days. The product consists of HypnoVR® virtual reality software and HypnoVR® Compagnon remote control software. HypnoVR® is a CE-marked class 1 medical device, developed and marketed by HypnoVR SAS, an ISO 13484:2016 and ISO 27001:2017 certified company. The device works with a virtual reality headset, a personal audio device and a mobile terminal. The investigators will only use sessions of 10 to 20 minutes. For each type of session, a visual universe, a musical atmosphere and a male or female voice are defined. Typically, the scenarios include 3 phases: preparation, hypnosis and return. We will use the following sessions: anxiety, pain, rehabilitation.

Intervention Type DEVICE

usual health care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients over 18 years old
* scheduled for a major surgery (cardiothoracic surgery or a major abdominal surgery)
* Written informed consent from patient.
* Admitted in a surgical ICU for a postoperative care for at least 48 hours.
* Absence of delirium at inclusion (RASS and CAM-ICU scale)

Exclusion Criteria

* Missing informed consent
* Patient strictly under 18 years old
* Inclusion in other study within the last 30 days
* Pregnancy
* Emergency hospitalization
* Progressive sepsis
* Patient transferred from another intensive care unit
* Short-term life-threatening condition
* Active psychiatric illness requiring antidepressant, antipsychotic or anxiolytic treatment
* Mechanical ventilation \> 48 hours
* Patient known to have cognitive disorders.
* Unbalanced epilepsy
* Visual problems (absence of binocular vision, blindness) and/or auditory problems (deafness) preventing the use of virtual reality
* Pregnant or breast-feeding women
* Patients under guardianship or deprived of their liberty
* Patients not registered with the national social security system

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No