ElderlyADA-VRSPANCT05759026
Comparison of the Benefits of a Personalized Intervention (Virtual Environment and Device) Compared to Usual Care
A study testing Accompaing cares in people with Elderly, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The medical environment can create stressful and anxiety-provoking situations for patients, especially during painful procedures, particularly in older adults. These stressful environments have a deleterious effect on the quality of care, even putting the patient at risk and the health care team at risk. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Accompaing cares
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2023to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or Women
- Over 60 years old
- Subject affiliated to the Social Security
- Patient receiving 4 identical cares as part of routine care
Who cannot join
- Presence of visual and auditory disorders contraindicating the use of a VR headset;
- Unstabilized epilepsy;
- Acute psychiatric disorders
- Vulnerable population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Management of Pain and Anxiety, Using Virtual Reality, During the Care of Elderly Hospitalized Patients
The medical environment can create stressful and anxiety-provoking situations for patients, especially during painful procedures, particularly in older adults. These stressful environments have a deleterious effect on the quality of care, even putting the patient at risk and the health care team at risk. The search for a solution is therefore imperative. The evolution of new technologies, such as virtual reality (VR), seems to be an answer to this challenge. Through a multidisciplinary research (psychology and medicine), this project proposes to study the factors allowing to improve the management of older adults during their care using VR. More precisely, different individual factors (age, cognitive level, individual preferences...) and different virtual reality universes (relaxation, landscapes...) on different supports (headsets and touch tablet) will be studied in order to understand the roles of these factors on pain and anxiety management during care procedures. This trial is an interventional, randomized, open-label, single-center study of 100 people over 60 years old. The aim of this project is to improve the quality of life of hospitalized patients but also of caregivers in their work environment. It is expected a significant reduction of pain and anxiety during the intervention with a personalized equipment and environment, compared to usual care conditions. The hypotheisis is also that these interventions, aimed at reducing pain and anxiety in patients, will have beneficial effects on the quality of work life of the caregivers performing the care.
Read the detailed description
The management of pain and anxiety, during care, will be proposed to patients hospitalized in the geriatric department of the Cimiez Hospital in Nice. After signing the consent form, the equipment and the different virtual environments will be presented to the patient and he will choose his preferred environment.Each patient will be accompanied during a treatment (either in control condition, or in VR condition with a VR condition with a personalised environment (VREP), or in VR condition with a environment (VRNP) for an average of 15 minutes (including the completion of the (including the completion of scales and questionnaires). Assessments will be carried out just before the treatment and just after the treatment.
After the treatment, the caregiver will also be asked to complete a scale assessing After the treatment, the carer will also be asked to complete a scale assessing the treatment (2 minutes on average to complete this scale).
And at the end of the study, the caregivers who participated in the study will be asked to rate their acceptability of VR using the User Experience Survey.
- Conditions
- Elderly
- Being tested
- Accompaing cares
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accompaing caresOther
After signing the consent form, the patient will be randomised. The ones randomised in VR groups will choose their preferred environment (e.g. landscapes, animals...).
The participant will be managed during 1 care (one care in control condition (no material used), care with the VR headset, one care with the VR set and the prefered environnent of the patient) for an average of 30 minutes (including the completion of the scales and questionnaires).
| Study group | Role | What they receive |
|---|---|---|
| control condition | Experimental | The patient will be randomized so that the kind of intervention will be determined in a random way. Receives: Other: Accompaing cares |
| with VR | Experimental | The patient will be randomized so that the kind of intervention will be determined in a random way. Receives: Other: Accompaing cares |
| with VR personalised | Experimental | The patient will be randomized so that the kind of intervention will be determined in a random way. Receives: Other: Accompaing cares |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) - Pain and Anxiety
The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)
Measured: immediatly before care
Visual Analog Scale (VAS) - Pain and Anxiety
The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)
Measured: immediatly after care
Secondary outcomes (9)
HAD scale (Hospital Anxiety Depression scale)
This scale evaluates the anxiety that a subject presents, only in a given situation. This tool proposes statements to patients who must then indicate whether their current state corresponds to this statement. The patients can answer from 0 to 3 according to their current feeling. This questionnaire includes 7 items allowing to evaluate the anxiety of the patient. Higher score and worse score: 21
Measured: immediately beafore care
HAD scale (Hospital Anxiety Depression scale)
This scale evaluates the anxiety that a subject presents, only in a given situation. This tool proposes statements to patients who must then indicate whether their current state corresponds to this statement. The patients can answer from 0 to 3 according to their current feeling. This questionnaire includes 7 items allowing to evaluate the anxiety of the patient. Higher score and worse score : 21
Measured: immediately after care
Algo Plus Scale
The algoplus scale is a scale assessing pain in five categories of behaviors to be observed: face, gaze, complaints, body and general behavior. Only one behavior in a category needs to be observed to be considered active. Each active category, regardless of the number of behaviors observed, counts as one point. This scale evaluates from 0 (minimum score) to 5 (maximum score). The presence of pain is diagnosed if the total score is greater than or equal to 2
Measured: during care
Heart rate measurment with Oximeter
The heart rate is measured with the number of pulses per minute. This measurement aims to evaluate the changes in the heart rate that may be related to an emotional response (positive or negative) related to the care and / or the intervention implemented (VR and / or tablet).
Measured: 2 minutes before the medicale procedure
Heart rate measurment with Oximeter
The heart rate is measured with the number of pulses per minute. This measurement aims to evaluate the changes in the heart rate that may be related to an emotional response (positive or negative) related to the care and / or the intervention implemented (VR and / or tablet).
Measured: 2 minutes after the medicale procedure
Respiratory rate with Oximeter
The respiratory rate is the number of respiratory cycles (inhalation and exhalation) per unit of time, of each individual. This measurement aims to observe changes in the breathing rhythm related to a strong emotion (positive or negative) that could be related to the care and/or the intervention implemented.
Measured: 2 minutes before the medicale procedure
Respiratory rate with Oximeter
The respiratory rate is the number of respiratory cycles (inhalation and exhalation) per unit of time, of each individual. This measurement aims to observe changes in the breathing rhythm related to a strong emotion (positive or negative) that could be related to the care and/or the intervention implemented.
Measured: 2 minutes after the medicale procedure
Digital scale of care completion
After treatment, a numerical scale will be proposed to the caregiver who performed the treatment, in order to evaluate the performance of the treatment (difficulties, observation of the patient: discomfort/pain, quality of treatment). The associate investigator will then ask the caregiver to rate each item from 0 to 10. Worse outcome : 10
Measured: after each care
System Usability Scale (SUS)
To obtain the SUS score, the contributions to the score of each item must first be added together. The contribution to the score of each item ranges from 1 to 5. For items 1, 3, 5, 7, and 9, the contribution to the score is equal to the position on the scale minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the position on the scale.Multiply the sum of the scores by 2.5 to get the overall SU value. SUS scores range from 0 to 100. The higher the score, the greater the acceptability and usability
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start13 Jun 2023
- Primary completion22 May 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759026
- Sponsor's protocol ID
- 22-PP-23
- Acronym
- ADA-VRSPA
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corbel C, Le Cerf F, Capriz F, Vaillant-Ciszewicz AJ, Breaud J, Guerin O, Corveleyn X. Virtual reality for pain and anxiety management during painful procedures in hospitalized older patients: A randomized controlled trial. Contemp Clin Trials. 2026 Oct 15;171:108499. doi: 10.1016/j.cct.2026.108499. Online ahead of print.
PubMed 42880659Corbel C, Le Cerf F, Capriz F, Vaillant-Ciszewicz AJ, Breaud J, Guerin O, Corveleyn X. The management of pain and anxiety using virtual reality during the care of elderly hospitalized patients: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Aug;155:107990. doi: 10.1016/j.cct.2025.107990. Epub 2025 Jun 23.
PubMed 40562303
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Pain and Anxiety, Using Virtual Reality, During the Care of Elderly Hospitalized Patients
- ClinicalTrials.gov ID
- NCT05759026
- Acronym / sponsor ID
- ADA-VRSPA / 22-PP-23
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 8 Mar 2023 (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 medical environment can create stressful and anxiety-provoking situations for patients, especially during painful procedures, particularly in older adults. These stressful environments have a deleterious effect on the quality of care, even putting the patient at risk and the health care team at risk. The search for a solution is therefore imperative. The evolution of new technologies, such as virtual reality (VR), seems to be an answer to this challenge. Through a multidisciplinary research (psychology and medicine), this project proposes to study the factors allowing to improve the management of older adults during their care using VR. More precisely, different individual factors (age, cognitive level, individual preferences...) and different virtual reality universes (relaxation, landscapes...) on different supports (headsets and touch tablet) will be studied in order to understand the roles of these factors on pain and anxiety management during care procedures. This trial is an interventional, randomized, open-label, single-center study of 100 people over 60 years old. The aim of this project is to improve the quality of life of hospitalized patients but also of caregivers in their work environment. It is expected a significant reduction of pain and anxiety during the intervention with a personalized equipment and environment, compared to usual care conditions. The hypotheisis is also that these interventions, aimed at reducing pain and anxiety in patients, will have beneficial effects on the quality of work life of the caregivers performing the care.
Detailed description
The management of pain and anxiety, during care, will be proposed to patients hospitalized in the geriatric department of the Cimiez Hospital in Nice. After signing the consent form, the equipment and the different virtual environments will be presented to the patient and he will choose his preferred environment.Each patient will be accompanied during a treatment (either in control condition, or in VR condition with a VR condition with a personalised environment (VREP), or in VR condition with a environment (VRNP) for an average of 15 minutes (including the completion of the (including the completion of scales and questionnaires). Assessments will be carried out just before the treatment and just after the treatment.
After the treatment, the caregiver will also be asked to complete a scale assessing After the treatment, the carer will also be asked to complete a scale assessing the treatment (2 minutes on average to complete this scale).
And at the end of the study, the caregivers who participated in the study will be asked to rate their acceptability of VR using the User Experience Survey.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control condition | Experimental | Other: Accompaing caresThe patient will be randomized so that the kind of intervention will be determined in a random way. |
| with VR | Experimental | Other: Accompaing caresThe patient will be randomized so that the kind of intervention will be determined in a random way. |
| with VR personalised | Experimental | Other: Accompaing caresThe patient will be randomized so that the kind of intervention will be determined in a random way. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or Women
- Over 60 years old
- Subject affiliated to the Social Security
- Patient receiving 4 identical cares as part of routine care
Key exclusion criteria (4 listed)
- Presence of visual and auditory disorders contraindicating the use of a VR headset;
- Unstabilized epilepsy;
- Acute psychiatric disorders
- Vulnerable population
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 |
|---|---|---|
| Accompaing caresAfter signing the consent form, the patient will be randomised. The ones randomised in VR groups will choose their preferred environment (e.g. landscapes, animals...). The participant will be managed during 1 care (one care in control condition (no material used), care with the VR headset, one care with the VR set and the prefered environnent of the patient) for an average of 30 minutes (including the completion of the scales and questionnaires). | Other | control condition, with VR, with VR personalised |
Primary outcome
Visual Analog Scale (VAS) - Pain and Anxiety
Time frame: immediatly before care
The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)
Visual Analog Scale (VAS) - Pain and Anxiety
Time frame: immediatly after care
The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)
9 secondary outcomes
HAD scale (Hospital Anxiety Depression scale)
Time frame: immediately beafore care
HAD scale (Hospital Anxiety Depression scale)
Time frame: immediately after care
Algo Plus Scale
Time frame: during care
Heart rate measurment with Oximeter
Time frame: 2 minutes before the medicale procedure
Heart rate measurment with Oximeter
Time frame: 2 minutes after the medicale procedure
Respiratory rate with Oximeter
Time frame: 2 minutes before the medicale procedure
Respiratory rate with Oximeter
Time frame: 2 minutes after the medicale procedure
Digital scale of care completion
Time frame: after each care
System Usability Scale (SUS)
Time frame: at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 42880659Corbel C, Le Cerf F, Capriz F, Vaillant-Ciszewicz AJ, Breaud J, Guerin O, Corveleyn X. Virtual reality for pain and anxiety management during painful procedures in hospitalized older patients: A randomized controlled trial. Contemp Clin Trials. 2026 Oct 15;171:108499. doi: 10.1016/j.cct.2026.108499. Online ahead of print.
- Derived from this study: PubMed 40562303Corbel C, Le Cerf F, Capriz F, Vaillant-Ciszewicz AJ, Breaud J, Guerin O, Corveleyn X. The management of pain and anxiety using virtual reality during the care of elderly hospitalized patients: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Aug;155:107990. doi: 10.1016/j.cct.2025.107990. Epub 2025 Jun 23.
- 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. This study is not recruiting at the moment.
Olivier GUERIN principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accompaing cares in people with Elderly, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) - Pain and Anxiety (time frame: immediatly before care). The study lists 2 primary outcomes in all. 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 NCT05759026, which also lists 2 linked publications.
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 9 Feb 2026.