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Search / Trial NCT06830369

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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Feb 11, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Immersive Virtual Reality Discomfort Iprea Intensive Care Unit Delirium

ClinConnect Summary

This clinical trial is studying whether using immersive virtual reality (IVR) can help reduce discomfort for patients recovering in a surgical intensive care unit (ICU) after major surgeries, such as heart or abdominal operations. Patients often experience discomfort due to the environment in the ICU, like bright lights, loud noises, and the stress of recovery, which can affect their mental wellbeing. In this trial, 194 patients will be divided into two groups: one group will use IVR for relaxation twice a day during their ICU stay, while the other group will receive standard care without IVR. Researchers will evaluate how well the IVR helps with discomfort and other symptoms when patients leave the ICU.

To be eligible for this study, participants must be at least 18 years old, scheduled for major surgery, and able to provide consent. They should stay in the surgical ICU for at least 48 hours after their operation and not have any serious mental health issues or cognitive disorders. Participants can expect to spend a few days in the ICU, where they will either experience the virtual reality program or receive regular postoperative care. The trial will help researchers understand if virtual reality can improve comfort and overall recovery for patients in intensive care.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients over 18 years old
  • scheduled for a major surgery (cardiothoracic surgery or a major abdominal surgery)
  • Written informed consent from patient or next of kin.
  • 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

About Centre Hospitalier Universitaire, Amiens

The Centre Hospitalier Universitaire (CHU) Amiens is a leading academic medical center in France dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, CHU Amiens integrates patient care, education, and research to enhance treatment outcomes and improve patient quality of life. The institution is committed to ethical standards and regulatory compliance in its clinical research endeavors, aiming to contribute significantly to the medical community and the development of new therapeutic approaches. By fostering partnerships with various stakeholders, CHU Amiens strives to translate scientific discoveries into practical applications that benefit patients and healthcare systems alike.

Locations

Amiens, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported