Virtual RealityRV-SMRNCT06985732
Contribution of Virtual Reality to the Well-being of Elderly Patients Hospitalized in SMR
A study testing Virtual Reality in people with Virtual Reality, run by Centre Médical Porte Verte.
Trial summary
The objective of this clinical trial is to evaluate the effect of using virtual reality on the well-being of elderly patients hospitalized in SMR for 3 weeks. The study also allows to evaluate the effect of VR on apathy, and the autonomy of patients hospitalized in the SMR department for 3 weeks. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People hospitalized in the SMR unit at La Porte Verte Hospital for a minimum of 3 weeks,
- People with preserved or slightly impaired cognitive status with an MMSE ≥ 20,
- People who have been informed and have signed written informed consent
Who cannot join
- People under guardianship or curatorship,
- People with difficulty understanding the VR study and materials,
- People with vision problems that impact the use of VR,
- People with hearing problems that impact the use of VR,
- People with epilepsy,
- People at risk of nausea and dizziness when using the VR headset,
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- People who cannot tolerate the VR headset,
- Not affiliated with a social security scheme.
- People receiving care with reflexology and relaxation massage
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fatima Zohra IZEDAREN contact
About this study
The objective of this clinical trial is to evaluate the effect of using virtual reality on the well-being of elderly patients hospitalized in SMR for 3 weeks. The study also allows to evaluate the effect of VR on apathy, and the autonomy of patients hospitalized in the SMR department for 3 weeks.
Read the detailed description
Patients meeting the inclusion criteria and agreeing to participate in the study will be enrolled and then randomized to either the VR immersion group or the control group. Patients included in the protocol will not undergo any changes to their care. Patients in the experimental group will receive 12 virtual reality sessions in addition to their usual care.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Use of virtual reality to elicit positive emotions and improve the well-being of elderly patients hospitalized in SMR
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Not described Receives: Other: Virtual Reality |
| contrrol arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO-5
measure well-being. The score is between 0-100 a high score means better wellness
Measured: 4 times throughout of study at baseline and after each VR session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Médical Porte Verte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985732
- Sponsor's protocol ID
- 2025-A00983-46
- Acronym
- RV-SMR
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Virtual Reality to the Well-being of Elderly Patients Hospitalized in SMR
- ClinicalTrials.gov ID
- NCT06985732
- Acronym / sponsor ID
- RV-SMR / 2025-A00983-46
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Médical Porte VerteUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 May 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 objective of this clinical trial is to evaluate the effect of using virtual reality on the well-being of elderly patients hospitalized in SMR for 3 weeks. The study also allows to evaluate the effect of VR on apathy, and the autonomy of patients hospitalized in the SMR department for 3 weeks.
Detailed description
Patients meeting the inclusion criteria and agreeing to participate in the study will be enrolled and then randomized to either the VR immersion group or the control group. Patients included in the protocol will not undergo any changes to their care. Patients in the experimental group will receive 12 virtual reality sessions in addition to their usual care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Other: Virtual Reality |
| contrrol arm | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- People hospitalized in the SMR unit at La Porte Verte Hospital for a minimum of 3 weeks,
- People with preserved or slightly impaired cognitive status with an MMSE ≥ 20,
- People who have been informed and have signed written informed consent
Key exclusion criteria (9 listed)
- People under guardianship or curatorship,
- People with difficulty understanding the VR study and materials,
- People with vision problems that impact the use of VR,
- People with hearing problems that impact the use of VR,
- People with epilepsy,
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 RealityUse of virtual reality to elicit positive emotions and improve the well-being of elderly patients hospitalized in SMR | Other | VR group |
Primary outcome
WHO-5
Time frame: 4 times throughout of study at baseline and after each VR session
measure well-being. The score is between 0-100 a high score means better wellness
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 28 May 2025.
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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.
Fatima Zohra IZEDAREN contact
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Virtual Reality, run by Centre Médical Porte Verte.
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 9 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 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Baptiste ISABET (0634227138 ext. 0033, Baptiste.ISABET@lpv.univi.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO-5 (time frame: 4 times throughout of study at baseline and after each VR session). 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 28 May 2025.