Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06830369

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-18

194

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old
  • Scheduled for major cardiothoracic or major abdominal surgery
  • Written informed consent from patient
  • Admitted to a surgical ICU for postoperative care for at least 48 hours
  • No delirium at inclusion (assessed by RASS and CAM-ICU scales)
Not Eligible

You will not qualify if you...

  • Missing informed consent
  • Patients under 18 years old
  • Participation in another study within the last 30 days
  • Pregnancy or breastfeeding
  • Emergency hospitalization
  • Progressive sepsis
  • Transfer from another intensive care unit
  • Short-term life-threatening condition
  • Active psychiatric illness requiring antidepressant, antipsychotic, or anxiolytic treatment
  • Mechanical ventilation longer than 48 hours
  • Known cognitive disorders
  • Uncontrolled epilepsy
  • Visual or auditory problems preventing use of virtual reality
  • Patients under guardianship or deprived of liberty
  • Not registered with the national social security system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHRU Amiens

Amiens, France, 80054

Actively Recruiting

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Research Team

C

Colin DEVOS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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