Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06830369

Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit of a French University Hospital: Monocentric, Prospective, Randomized Controlled Trial Using HypnoVR®

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

194

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the effect of immersive virtual reality (IVR) using HypnoVR® on reducing discomfort for patients admitted to a surgical intensive care unit (ICU) following major surgeries such as cardiac, thoracic, or major abdominal operations. The study aims to assess whether this VR program can help ease discomfort related to the ICU environment and care, which often causes psychological effects. It is a prospective, randomized controlled trial enrolling 194 patients in a single hospital setting.

CONDITIONS

Brief 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 a major cardiothoracic or major abdominal surgery
  • Provided written informed consent
  • Admitted to a surgical ICU for postoperative care for at least 48 hours
  • No delirium at inclusion as assessed by RASS and CAM-ICU scales
Not Eligible

You will not qualify if you...

  • Missing informed consent
  • Under 18 years old
  • Participated in another study within the last 30 days
  • Pregnant or breastfeeding
  • Emergency hospitalization
  • Progressive sepsis
  • Transferred from another intensive care unit
  • Short-term life-threatening condition
  • Active psychiatric illness requiring antidepressant, antipsychotic, or anxiolytic treatment
  • Mechanical ventilation for more than 48 hours
  • Known cognitive disorders
  • Uncontrolled epilepsy
  • Visual or auditory problems preventing virtual reality use
  • 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 to 5 days

Participants receive virtual reality sessions with HypnoVR® twice daily after extubation for 2 to 5 days or receive usual health care.

Twice-daily sessions during ICU stay

Follow-up

Duration - 1 month

Participants are assessed for anxiety and depression one month after discharge from intensive care.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

CHRU Amiens

Amiens, France, 80054

Actively Recruiting

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Research Team

C

Colin DEVOS

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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Published Research Related To This Trial

Effect of a virtual reality program on patient comfort in the surgical intensive care unit of a French university hospital: study protocol for a monocentric, prospective, superiority, randomised controlled trial-ZION study.

Pierre Huette, Stéphanie Malaquin, Thomas Lefebvre...

https://pubmed.ncbi.nlm.nih.gov/40675645