Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

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

Study details
    Immersive Virtual Reality
    Discomfort
    IPREA
    Intensive Care Unit
    Delirium

NCT06830369

Centre Hospitalier Universitaire, Amiens

1 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.