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

Sponsor
Centre Hospitalier Universitaire, Amiens
Study ID
NCT06830369
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • usual health care — OTHER
    usual health care

Study Details

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.

Key Dates

First listed
Feb 17, 2025
Start date
Sep 12, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: standard group
  • Experimental: intervention group

Primary Outcome Measure

IPREA questionnaire value [ Time Frame: at the day of ICU-discharge from intensive care, within 5 days ]

Central Contacts

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