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

NCT06830369 | Recruiting

• 1 other identifier: PI2024_843_0082
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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

Immersive Virtual Reality; Discomfort; IPREA; Intensive Care Unit; Delirium

Keywords

Immersive virtual reality; discomfort; IPREA; intensive care unit; delirium

Outcome Measures

Primary Outcomes (1)

• IPREA questionnaire value

  The primary endpoint will be the 18-item IPREA questionnaire on the day of ICU discharge from intensive care. Each item of the questionnaire includes factors such as noise, light, bed, sleep, thirst, hunger, cold, heat, pain, medical device, intimacy, anxiety, isolation, visiting hours, phone, information, breath and depression. It represents a valid French questionnaire on self-perceived discomfort in intensive care, which is the only discomfort assessment instrument validated for use in the ICU.

  at the day of ICU-discharge from intensive care, within 5 days

Secondary Outcomes (6)

• Intensity of discomfort symptoms

  at the day of ICU-discharge from intensive care, within 5 days

• Delirium incidence

  daily until ICU discharge (within 5 days)

• Cumulative opioid consumption (morphine or oxycodone)

  At ICU discharge day (within 5 days)

• Length of stay (in days)

  At ICU discharge day (within 5 days)

• Anxiety and depression at 1 month

  at 1 month after discharge from intensive care

Study Arms (2)

standard group

ACTIVE COMPARATOR

Other: usual health care

intervention group

EXPERIMENTAL

Device: HypnoVR

Interventions

HypnoVR 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.

intervention group

usual health care OTHER

usual health care

standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Missing informed consent
• Patient strictly under 18 years old
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHRU Amiens

Amiens, 80054, France

RECRUITING

Related Publications (1)

• Huette P, Malaquin S, Lefebvre T, Devos C, Ibrahima A, Daumin C, Coupez A, Josse E, Besserve P, Haye G, Bayart G, Guilbart M, Gibert L, Beyls C, Dupont H, Meynier J, Diouf M, Mahjoub Y, Abou-Arab O. 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. BMJ Open. 2025 Jul 17;15(7):e101243. doi: 10.1136/bmjopen-2025-101243.

  PMID: 40675645 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Colin DEVOS

CONTACT

33+322087899; Devos.colin@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)