Immersive Virtual RealityZIONNCT06830369
Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit
A study testing HypnoVR and usual health care in people with Immersive Virtual Reality and Discomfort, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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...). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immersive Virtual Reality, Discomfort, IPREA
- What is being tested?
- HypnoVR and usual health care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Absence of delirium at inclusion (RASS and CAM-ICU scale)
- Pregnancy
Show all 18Show fewer
- 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
Who cannot join
- Missing informed consent
- Patient strictly under 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens, 80054
Colin Devos, 33+322087899, Devos.colin@chu-amiens.fr
Osama ABOU ARAB, MD, PhD
About this study
Official title: 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, Randomized Controlled Trial, With Blinded End-point (PROBE), ZION Study
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
- Being tested
- HypnoVR, usual health care
- Keywords
- Immersive virtual reality, discomfort, IPREA, intensive care unit, delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoVRDevice
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 careOther
usual health care
| Study group | Role | What they receive |
|---|---|---|
| standard group | Active comparator | Not described Receives: Other: usual health care |
| intervention group | Experimental | Not described Receives: Device: HypnoVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the day of ICU-discharge from intensive care, within 5 days
Secondary outcomes (6)
Intensity of discomfort symptoms
The intensity of the following discomfort symptoms assessed on the day of discharge from intensive care (within 5 days) : anxiety, pain, dyspnea, thirst and sleep deprivation. The intensity of these discomforts will be assessed using a NRS ranging from 0 to 10 (0 = no discomfort; 10 = worst possible symptom).
Measured: at the day of ICU-discharge from intensive care, within 5 days
Delirium incidence
The incidence of delirium measured using the CAM-ICU and RASS scale, daily until discharge from intensive care.
RASS is the Richmond agitation \& sedation scale (RASS) The RASS score ranges from a score of -5, where a patient is deemed "unarousable", to a score of +4, where a patient is "violent and immediate danger to staff". If the RASS score is too low (less than -3), meaning that the patient is too drowsy or sedated, then the CAM-ICU cannot be performed .
CAM-ICU is : The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool specifically designed to assess for delirium in the context of ICU patients, including those on mechanical ventilation.
The final CAM-ICU- score is positive for delirium or negative for delirium.
Measured: daily until ICU discharge (within 5 days)
Cumulative opioid consumption (morphine or oxycodone)
Cumulative opioid consumption (morphine or oxycodone) expressed in milligrams at discharge from intensive care,
Measured: At ICU discharge day (within 5 days)
Length of stay (in days)
Length of stay is defined in days between admission to intensive care and discharge from the hospital.
Measured: At ICU discharge day (within 5 days)
Anxiety and depression at 1 month
Anxiety and depression at 1 month (V2 follow-up visit) after discharge from intensive care using the HAD scale.
HAD scale is : Hospital Anxiety and Depression Scale (HADS) is a 14-item scale, with seven items relating to anxiety and seven relating to depression.
Scores are :
0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Measured: at 1 month after discharge from intensive care
Patient experience score
Patient experience of device use on discharge from intensive care, using a numeric scale from 1 to 5.
- Dissatisfied / did not wish to repeat the experience
- Not very satisfied with the experience
- Moderately satisfied with the experience
- Satisfied with the experience
- Very satisfied / Would like to repeat the experience
Measured: At ICU discharge day (within 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start12 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immersive Virtual RealityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830369
- Sponsor's protocol ID
- PI2024_843_0082
- Acronym
- ZION
- Status last verified
- Nov 2025
- First submitted
- 11 Feb 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40675645
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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, Randomized Controlled Trial, With Blinded End-point (PROBE), ZION Study
- ClinicalTrials.gov ID
- NCT06830369
- Acronym / sponsor ID
- ZION / PI2024_843_0082
- Conditions
- Immersive Virtual Reality, Discomfort, IPREA, Intensive Care Unit, Delirium
- Keywords
- Immersive virtual reality, discomfort, IPREA, intensive care unit, delirium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Active comparator | Other: usual health care |
| intervention group | Experimental | Device: HypnoVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- Absence of delirium at inclusion (RASS and CAM-ICU scale)
Key exclusion criteria (2 listed)
- Missing informed consent
- Patient strictly under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnoVRIn 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. | Device | intervention group |
| usual health careusual health care | Other | standard group |
Primary outcome
IPREA questionnaire value
Time frame: at the day of ICU-discharge from intensive care, within 5 days
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.
6 secondary outcomes
Intensity of discomfort symptoms
Time frame: at the day of ICU-discharge from intensive care, within 5 days
Delirium incidence
Time frame: daily until ICU discharge (within 5 days)
Cumulative opioid consumption (morphine or oxycodone)
Time frame: At ICU discharge day (within 5 days)
Length of stay (in days)
Time frame: At ICU discharge day (within 5 days)
Anxiety and depression at 1 month
Time frame: at 1 month after discharge from intensive care
Patient experience score
Time frame: At ICU discharge day (within 5 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 40675645Huette 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HypnoVR and usual health care in people with Immersive Virtual Reality and Discomfort, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin DEVOS (33+322087899, Devos.colin@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPREA questionnaire value (time frame: at the day of ICU-discharge from intensive care, within 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.