AnxietyVRAINCT06747793
Virtual Reality to Reduce the Anxiety in Critically Ill Patient
A study testing Virtual Reality in people with Anxiety and Intensive Care Unit Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Anxiety and discomfort generated by repeated medical cares and invasive procedures can induce cognitive disorders in critical illness survivors as post-traumatic stress disorder. For this reason, managing patients' anxiety is particularly important in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Intensive Care Unit Syndrome
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2025to Jan 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
- Adult patient
- Oral consent after free and informed information
- Hospitalized in the multipurpose intensive care unit of Rangueil hospital with an estimated length of stay greater than 24 hours
- Conscious (Glasgow Coma Scale > 8) and Richmond Agitation-Sedation Scale (RASS) sedation score between -1 and +1
- Mechanically ventilated or not
- Person affiliated to or beneficiary of a social security system.
Who cannot join
- Patient under legal protection (guardianship or curatorship)
- RASS < -1 or > +1
- Visual or hearing difficulties preventing the use of the VR headset
- Severe psychiatric history (severe depression, psychosis, bipolarity), advanced dementia or mental retardation
- Hemodynamic (Norepinephrine support > 0.5 gamma/kg/min) and/or respiratory instability (invasive mechanical ventilation with FiO2 greater than 80%)
- Presence of a malformation or cervical or facial trauma that does not allow the application of the VR headset
- Pregnancy or breastfeeding
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
University Hospital of Toulouse
Toulouse
Floriane PUEL, MD
Floriane PUEL, MD
About this study
Official title: Evaluation of the Use of Virtual Reality to Reduce Anxiety in Intensive Care Patients
Anxiety and discomfort generated by repeated medical cares and invasive procedures can induce cognitive disorders in critical illness survivors as post-traumatic stress disorder. For this reason, managing patients' anxiety is particularly important in the intensive care unit. Physicians have recently started using immersive virtual reality (VR), based on real-time interaction with an artificial 360° immersive world, as an adjunctive non-invasive and non-pharmacological anxiolysis technique. The purpose of this project is to assess the virtual reality stimulation to reduce anxiety in Intensive Care Unit (ICU) patients.
Read the detailed description
Physicians have recently started using immersive VR as an adjunctive non-invasive and non-pharmacological pain control and anxiolysis technique, but the literature on this topic in the adult ICU is quite sparse. In a pilot study, Gerber et al showed the feasibility and acceptance of VR stimulation as a new non-pharmacological intervention to comfort patients during their stay in the ICU and the results appear promising [11]. In our view, the management of anxiety related to healthcare interventions remains a major global challenge and it will be interesting to assess the use of VR in a chronic daily use in the ICU adult patients. Our study will be conducted in the adult intensive care unit of the University of Toulouse, France. All patients who meet the inclusion criteria will be randomized. There will be two distinct groups: the control group will receive standard ICU care, whereas the intervention group will, in addition to the standard ICU care, will receive relaxing VR stimulation two times a day. The intervention will be performed by trained ICU nurses. Anxiety will be assessed by the Visual Analogue Scale for Anxiety (VAS-A) twice by day (morning and evening), sleep quality with the Richards-Campbell Sleep Questionnaire (RCSQ) every morning, depression, and anxiety with the Hamilton Depression Rating Scale (HDRS) and the Hamilton Anxiety Rating Scale (HAM-A) at 3-months after the inclusion. Each patient's heart rate, blood pressure, respiration rate, SatO2, and physical or neurocognitive side effects were used to evaluate if the VR sessions will have any effect on physiology.
- Conditions
- Anxiety, Intensive Care Unit Syndrome
- Being tested
- Virtual Reality
- Keywords
- Intensive care unit, virtual reality, anxiety, depression, sleep quality
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
The intervention will consist of relaxing virtual reality stimulation, which will be started after obtaining informed consent. Immersive 360-degree videos (nature environments) will be played inside a head-mounted display, with the video sound played inside headphones. Each virtual reality video will last 30 minutes. The stimulation will be provided two times per day, morning and evening, every day until the patient ICU discharge, or the maximum of 7 days will be reached. The intervention group will also receive standard intensive care unit care, same as in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Control group: | No intervention | Standard intensive care unit care without virtual reality stimulation. |
| Interventional group: | Experimental | Standard intensive care unit care and 30 minutes of virtual reality stimulation two times per day. Receives: Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' anxiety level after using virtual reality
Visual Analogue Scale for Anxiety (VAS-A) is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety
Measured: 7 days
Secondary outcomes (6)
Difference in patient anxiety after using virtual reality
Visual Analogue Scale for Anxiety (VAS-A) variations between inclusion and the day 7. The VAS A is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety
Measured: between inclusion and the day 7
Evolution of the psychopathological status: depression
Score to the Hamilton Depression Rating Scale (HDRS) with 16 items from 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 30: 0 no depression / 30: depression maximum
Measured: 3 months
Evolution of the psychopathological status: anxiety
Score to the Hamilton Anxiety Rating Scale (HAM-A) with 14 items rom 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 56: 0 no anxiety /56: anxiety maximum
Measured: 3 months
Evolution of the Sleep quality
Score to the Richards-Campbell Sleep Questionnaire (RCSQ) from 0 to 100 (0: worse sleep /100: best sleep
Measured: every day through study completion, an average of 5 days
Evaluation of the Safety of using vitural reality in intensive care unit
Number of side effects that may occur during a VR session
Measured: every day through study completion, an average of 5 days
Evaluation of the compliance
Number of virtual reality sessions actually performed by the patient in the intervention group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study startFeb 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical interventional trial, randomized, monocentric in the Intensive Care Unit of Toulouse University Hospital.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Floriane PUEL, Dr, Principal investigator, Hôpital Rangueil, CHU de Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747793
- Sponsor's protocol ID
- RC31/23/0617
- Acronym
- VRAI
- Status last verified
- Jan 2025
- First submitted
- 12 Nov 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Virtual Reality to Reduce Anxiety in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06747793
- Acronym / sponsor ID
- VRAI / RC31/23/0617
- Conditions
- Anxiety, Intensive Care Unit Syndrome
- Keywords
- Intensive care unit, virtual reality, anxiety, depression, sleep quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Dec 2024 (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.
Anxiety and discomfort generated by repeated medical cares and invasive procedures can induce cognitive disorders in critical illness survivors as post-traumatic stress disorder. For this reason, managing patients' anxiety is particularly important in the intensive care unit. Physicians have recently started using immersive virtual reality (VR), based on real-time interaction with an artificial 360° immersive world, as an adjunctive non-invasive and non-pharmacological anxiolysis technique. The purpose of this project is to assess the virtual reality stimulation to reduce anxiety in Intensive Care Unit (ICU) patients.
Detailed description
Physicians have recently started using immersive VR as an adjunctive non-invasive and non-pharmacological pain control and anxiolysis technique, but the literature on this topic in the adult ICU is quite sparse. In a pilot study, Gerber et al showed the feasibility and acceptance of VR stimulation as a new non-pharmacological intervention to comfort patients during their stay in the ICU and the results appear promising [11]. In our view, the management of anxiety related to healthcare interventions remains a major global challenge and it will be interesting to assess the use of VR in a chronic daily use in the ICU adult patients. Our study will be conducted in the adult intensive care unit of the University of Toulouse, France. All patients who meet the inclusion criteria will be randomized. There will be two distinct groups: the control group will receive standard ICU care, whereas the intervention group will, in addition to the standard ICU care, will receive relaxing VR stimulation two times a day. The intervention will be performed by trained ICU nurses. Anxiety will be assessed by the Visual Analogue Scale for Anxiety (VAS-A) twice by day (morning and evening), sleep quality with the Richards-Campbell Sleep Questionnaire (RCSQ) every morning, depression, and anxiety with the Hamilton Depression Rating Scale (HDRS) and the Hamilton Anxiety Rating Scale (HAM-A) at 3-months after the inclusion. Each patient's heart rate, blood pressure, respiration rate, SatO2, and physical or neurocognitive side effects were used to evaluate if the VR sessions will have any effect on physiology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical interventional trial, randomized, monocentric in the Intensive Care Unit of Toulouse University Hospital.
| Arm | Type | Receives |
|---|---|---|
| Control group: | No intervention | –Standard intensive care unit care without virtual reality stimulation. |
| Interventional group: | Experimental | Other: Virtual RealityStandard intensive care unit care and 30 minutes of virtual reality stimulation two times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient
- Oral consent after free and informed information
- Hospitalized in the multipurpose intensive care unit of Rangueil hospital with an estimated length of stay greater than 24 hours
- Conscious (Glasgow Coma Scale > 8) and Richmond Agitation-Sedation Scale (RASS) sedation score between -1 and +1
- Mechanically ventilated or not
Key exclusion criteria (7 listed)
- Patient under legal protection (guardianship or curatorship)
- RASS < -1 or > +1
- Visual or hearing difficulties preventing the use of the VR headset
- Severe psychiatric history (severe depression, psychosis, bipolarity), advanced dementia or mental retardation
- Hemodynamic (Norepinephrine support > 0.5 gamma/kg/min) and/or respiratory instability (invasive mechanical ventilation with FiO2 greater than 80%)
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 |
|---|---|---|
| Virtual RealityThe intervention will consist of relaxing virtual reality stimulation, which will be started after obtaining informed consent. Immersive 360-degree videos (nature environments) will be played inside a head-mounted display, with the video sound played inside headphones. Each virtual reality video will last 30 minutes. The stimulation will be provided two times per day, morning and evening, every day until the patient ICU discharge, or the maximum of 7 days will be reached. The intervention group will also receive standard intensive care unit care, same as in the control group. | Other | Interventional group: |
Primary outcome
Patients' anxiety level after using virtual reality
Time frame: 7 days
Visual Analogue Scale for Anxiety (VAS-A) is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety
6 secondary outcomes
Difference in patient anxiety after using virtual reality
Time frame: between inclusion and the day 7
Evolution of the psychopathological status: depression
Time frame: 3 months
Evolution of the psychopathological status: anxiety
Time frame: 3 months
Evolution of the Sleep quality
Time frame: every day through study completion, an average of 5 days
Evaluation of the Safety of using vitural reality in intensive care unit
Time frame: every day through study completion, an average of 5 days
Evaluation of the compliance
Time frame: 3 months
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 27 Jan 2025.
- 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.
Floriane PUEL, Dr principal investigator
Hôpital Rangueil, CHU de Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Anxiety and Intensive Care Unit Syndrome, run by University Hospital, Toulouse 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Jan 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 Floriane PUEL, Dr (05 61 32 22 25, puel.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' anxiety level after using virtual reality (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2025.