Adult Patients Managed in a Cardiac Critical Care Unit With a Pathology Requiring at Least One Potentially Painful and Anxiety-provoking Invasive ProcedureS'OUVRIRNCT07132710
Reorganization Strategy to Optimize the Use of Virtual Reality
An observational study of Adult Patients Managed in a Cardiac Critical Care Unit With a Pathology Requiring at Least One Potentially Painful and Anxiety-provoking Invasive Procedure, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The benefits of virtual reality (VR) in managing pain and anxiety for critical care patients has never been demonstrated, even if a positive effect has been demonstrated in other populations of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adult Patients Managed in a Cardiac Critical Care Unit With a Pathology Requiring at Least One Potentially Painful and Anxiety-provoking Invasive Procedure
- What is being tested?
- Semi-structured interviews
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: As for the caregivers, the team is currently made up of 42 nurses and 35 care assitants, so our sample will be 12 nurses and 8 care assistants to be representative of the team. As for the patients,10 volunteer from the cardiac critical care unit who meet the eligibility criteria will be selected to ensure the greatest possible diversity of patient profiles.
Who may be able to join
- Volunteer caregivers working in the cardiac critical care unit for at least 6 months.
- Adult patients treated in the unit with a condition requiring at least one potentially painful and anxiety-provoking invasive procedure (e.g., Central Venous Line placement, Arterial Catheter Insertion, ...) allowing the use of the VR mask.
- Patients able to understand the instructions without language barriers, to ensure the validity of the interviews and the quality of the data collected.
Who cannot join
- Staff not volunteering to participate in the study.
- Patients whose condition presents a medical contraindication to the use of VR mask or who present cognitive disorders.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Louis Pradel - Hospices Civils de Lyon
Bron, France, 69500
About this study
Official title: Strategy for Optimizing the Use of Virtual Reality by Reorganizing Practices
The benefits of virtual reality (VR) in managing pain and anxiety for critical care patients has never been demonstrated, even if a positive effect has been demonstrated in other populations of patients. A preliminary survey in 8 critical care units equipped with the VR mask, identified a under-use of masks by critical care teams. Before addressing the question of the effectiveness of the VR mask in a population of critical care patients, we must first identify the barriers and facilitators to its use and propose a new organization in critical care units promoting the use of VR mask by autonomous caregivers. A qualitative study will be conducted with patients and caregivers of a critical care unit to identify the barriers and facilitators to the use of virtual reality masks in the management of pain and anxiety by caregivers.
- Being tested
- Semi-structured interviews
- Keywords
- Patient experience, virtual reality, critical care, job satisfaction, organizational innovation, qualitative study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
Patients and caregivers will be interviewed about the barriers and facilitators to the use of VR masks in the management of pain and anxiety, in order to propose organizational changes that encourage their use.
| Study group | Role | What they receive |
|---|---|---|
| VR mask potential users in critical care | Patients and caregivers of cardiac critical care units likely to use a VR mask for therapeutic purposes Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the barriers and facilitators to the use of virtual reality mask by paramedical staff in the management of invasive care for critical care patients
Patients and caregivers of a cardiac critical care unit will be interviewed (semi-structured interviews) to gather their perceptions on the use of virtual reality mask for pain and anxiety management in invasive care for critical care patients
Measured: Participants will be interviewed once (about one-hour interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Managed in a Cardiac Critical Care Unit With a Pathology Requiring at Least One Potentially Painful and Anxiety-provoking Invasive ProcedureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132710
- Sponsor's protocol ID
- 69HCL24_1241
- Acronym
- S'OUVRIR
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Optimizing the Use of Virtual Reality by Reorganizing Practices
- ClinicalTrials.gov ID
- NCT07132710
- Acronym / sponsor ID
- S'OUVRIR / 69HCL24_1241
- Keywords
- Patient experience, virtual reality, critical care, job satisfaction, organizational innovation, qualitative study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Aug 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.
The benefits of virtual reality (VR) in managing pain and anxiety for critical care patients has never been demonstrated, even if a positive effect has been demonstrated in other populations of patients. A preliminary survey in 8 critical care units equipped with the VR mask, identified a under-use of masks by critical care teams. Before addressing the question of the effectiveness of the VR mask in a population of critical care patients, we must first identify the barriers and facilitators to its use and propose a new organization in critical care units promoting the use of VR mask by autonomous caregivers. A qualitative study will be conducted with patients and caregivers of a critical care unit to identify the barriers and facilitators to the use of virtual reality masks in the management of pain and anxiety by caregivers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR mask potential users in critical care | – | Other: Semi-structured interviewsPatients and caregivers of cardiac critical care units likely to use a VR mask for therapeutic purposes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- As for the caregivers, the team is currently made up of 42 nurses and 35 care assitants, so our sample will be 12 nurses and 8 care assistants to be representative of the team. As for the patients,10 volunteer from the cardiac critical care unit who meet the eligibility criteria will be selected to ensure the greatest possible diversity of patient profiles.
Key inclusion criteria (3 listed)
- Volunteer caregivers working in the cardiac critical care unit for at least 6 months.
- Adult patients treated in the unit with a condition requiring at least one potentially painful and anxiety-provoking invasive procedure (e.g., Central Venous Line placement, Arterial Catheter Insertion, ...) allowing the use of the VR mask.
- Patients able to understand the instructions without language barriers, to ensure the validity of the interviews and the quality of the data collected.
Key exclusion criteria (2 listed)
- Staff not volunteering to participate in the study.
- Patients whose condition presents a medical contraindication to the use of VR mask or who present cognitive disorders.
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 |
|---|---|---|
| Semi-structured interviewsPatients and caregivers will be interviewed about the barriers and facilitators to the use of VR masks in the management of pain and anxiety, in order to propose organizational changes that encourage their use. | Other | VR mask potential users in critical care |
Primary outcome
Identify the barriers and facilitators to the use of virtual reality mask by paramedical staff in the management of invasive care for critical care patients
Time frame: Participants will be interviewed once (about one-hour interview)
Patients and caregivers of a cardiac critical care unit will be interviewed (semi-structured interviews) to gather their perceptions on the use of virtual reality mask for pain and anxiety management in invasive care for critical care patients
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 20 Aug 2025.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Patients Managed in a Cardiac Critical Care Unit With a Pathology Requiring at Least One Potentially Painful and Anxiety-provoking Invasive Procedure, run by Hospices Civils de Lyon 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 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the barriers and facilitators to the use of virtual reality mask by paramedical staff in the management of invasive care for critical care patients (time frame: Participants will be interviewed once (about one-hour interview)). 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 20 Aug 2025.