Older AdultNCT06519253
Virtual Reality Music in Geriatric Inpatients
A study testing Virtual reality (VR) music intervention in people with Older Adult and Hospitalization, run by St. Mary's Research Center, Canada at 1 site in Canada.
Trial summary
Older adults, especially those in acute care require accessible non-pharmacological interventions, such as music to improve their mental health. Immersive 360 virtual reality (VR), is an innovative technology that has been found to be feasible, safe, and enjoyable by older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older Adult, Hospitalization
- What is being tested?
- Virtual reality (VR) music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 22 May 2024to 22 May 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
- Age of 60 years or older;
- Medical stability to participate in the trial as determined by treating physician (defined as stable vital signs, absence of new medical events and deteriorating signs),
- Admitted to the GAU (5 north) at St. Mary's hospital.
Who cannot join
- Medical instability which limits ability to participate in the study (unstable vital signs, delirium, new medical events, deteriorating signs),
- Unablility to communicate in English or French,
- Behavioural issues/delirium that limit participation in the study,
- Those who have very severe dementia (using the Reisberg stage 7 which is defined by very limited communication ability, and dependence for all self-care
- Those without sufficient auditory acuity to undergo assessment and participate in the intervention, which affects their ability to communicate their consent for this study and to listen to music
- Ophthalmological conditions which affects their ability to participate in the immersive VR (recent eye surgery, severe macular degeneration, severe glaucoma, epilepsy and seizures, etc.).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St.Mary's Research Centre
Montreal, Quebec, H3T 0A2
Julia Chabot, julia.chabot@mcgill.ca
Harmehr Sekhon, harmehr.sekhon@mcgill.ca
About this study
Official title: Virtual Reality Based Music Intervention in an Acute Geriatric Setting
Older adults, especially those in acute care require accessible non-pharmacological interventions, such as music to improve their mental health. Immersive 360 virtual reality (VR), is an innovative technology that has been found to be feasible, safe, and enjoyable by older adults. However, VR based music intervention to improve older adults' mental health has not been studied in acute in-patient settings.
- Conditions
- Older Adult, Hospitalization
- Being tested
- Virtual reality (VR) music intervention, Music only control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality (VR) music interventionOther
The VR music intervention consists of musical performance which were already recorded. This is accessible classic music. During the intervention, the participants will be able to see the musicians (and the stage, empty auditorium, etc.) and hear the music.
Music only controlOther
The control group consists of the same musical performances, with the audio only
| Study group | Role | What they receive |
|---|---|---|
| VR Music- Intervention | Experimental | Treatment Group: music intervention via virtual reality (VR)
The music intervention aims to reproduce the experience of a musical performance. During the intervention, the participants will wear a VR headset which will give them an immersive experience of attending a virtual performance. During the intervention, the participants will be able to see the musicians (and the stage, empty auditorium, etc.) and hear the music.
The participants in the VR intervention will be seated during the 15 minutes of intervention and the research assistant will stay at their side during the entire intervention. There will be no hand-help components to the VR intervention. Should the participant express any discomfort or have any questions/concerns with the intervention, the research assistant will be available and able to answer/assist the participants. Receives: Other: Virtual reality (VR) music intervention |
| Music- Active Control | Active comparator | The participants in the active control group will listen, via a headband, the same music as the VR music intervention group.
These participants will therefore not have an "immersive" experience as they will only hear the music (i.e they will not be able to see the musicians playing).
The participants in the music intervention via headband will remain seated during the 15 minutes of the intervention. During the intervention, the research assistant will stay at their side. Should the participant express any discomfort or have any questions/concerns with the intervention, the research assistant will be available and able to answer/assist the participants. Receives: Other: Music only control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the music VR program
The recruitment goals will be met (n=30) within 6 months, attrition will be ≤ 20% for follow-up. Intervention drop-out will be ≤30% (i.e. fail to attend 50% of the intervention), and VR participants will have <1 major technical issues
Measured: 2 Days
Tolerability of the music VR program
The intervention will be acceptable and well-tolerated according to the Simulator Sickness Questionnaire (SSQ). The SSQ questionnaire consists of 16 symptoms including fatigue, headache and nausea which are rated from 0 (none) to 4 (severe). Cut-off for tolerability is < 10 over 64 years of age.
Measured: 2 days
Acceptability of the music VR program
Participants randomized to VR will be willing to use VR again compared to the non-VR group. This means that they will have higher presences, according to the Slater-Usoh-Steed Presence Questionnaire (SUS) score 0-100, i.e. a significantly higher SUS score compared to the non-VR group. The intervention will be acceptable to patients and won't have an impact on the clinical load of the clinical team.
Measured: 2 Days
Secondary outcomes (2)
Preliminary efficacy of the VR based music intervention in improving positive emotions
Compared to the non-VR group, the VR based music group will have a greater improvement in positive emotions using the Visual Analog Mood
Measured: 2 Days
Preliminary efficacy of the VR based music intervention in improving pain
Compared to the non-VR group, the VR based music group will have a greater improvement in pain, using the Visual Analog Pain Scale
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start22 May 2024
- Primary completion22 Nov 2024 (estimated)
- Study completion22 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies 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
- Model description
- Our study proposes a feasibility open-label RCT of a novel VR based music intervention in an acute geriatric inpatient GAU setting to assess feasibility and efficacy in improving positive emotions, pain, mental wellbeing, symptoms of anxiety and depression in older adults.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Mary's Research Center, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harmehr Sekhon, PhD, St. Mary's Research Center, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519253
- Sponsor's protocol ID
- 2024-1020
- Status last verified
- Jul 2024
- First submitted
- 22 May 2024
- Last updated
- 25 Jul 2024
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Based Music Intervention in an Acute Geriatric Setting
- ClinicalTrials.gov ID
- NCT06519253
- Acronym / sponsor ID
- 2024-1020
- Conditions
- Older Adult, Hospitalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Mary's Research Center, CanadaUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 22 Nov 2024 (estimated)
- Study completion
- 22 May 2025 (estimated)
- First posted
- 25 Jul 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.
Older adults, especially those in acute care require accessible non-pharmacological interventions, such as music to improve their mental health. Immersive 360 virtual reality (VR), is an innovative technology that has been found to be feasible, safe, and enjoyable by older adults. However, VR based music intervention to improve older adults' mental health has not been studied in acute in-patient settings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our study proposes a feasibility open-label RCT of a novel VR based music intervention in an acute geriatric inpatient GAU setting to assess feasibility and efficacy in improving positive emotions, pain, mental wellbeing, symptoms of anxiety and depression in older adults.
| Arm | Type | Receives |
|---|---|---|
| VR Music- Intervention | Experimental | Other: Virtual reality (VR) music interventionTreatment Group: music intervention via virtual reality (VR) The music intervention aims to reproduce the experience of a musical performance. During the intervention, the participants will wear a VR headset which will give them an immersive experience of attending a virtual performance. During the intervention, the participants will be able to see the musicians (and the stage, empty auditorium, etc.) and hear the music. The participants in the VR intervention will be seated during the 15 minutes of intervention and the research assistant will stay at their side during the entire intervention. There will be no hand-help components to the VR intervention. Should the participant express any discomfort or have any questions/concerns with the intervention, the research assistant will be available and able to answer/assist the participants. |
| Music- Active Control | Active comparator | Other: Music only controlThe participants in the active control group will listen, via a headband, the same music as the VR music intervention group. These participants will therefore not have an "immersive" experience as they will only hear the music (i.e they will not be able to see the musicians playing). The participants in the music intervention via headband will remain seated during the 15 minutes of the intervention. During the intervention, the research assistant will stay at their side. Should the participant express any discomfort or have any questions/concerns with the intervention, the research assistant will be available and able to answer/assist the participants. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 60 years or older;
- Medical stability to participate in the trial as determined by treating physician (defined as stable vital signs, absence of new medical events and deteriorating signs),
- Admitted to the GAU (5 north) at St. Mary's hospital.
Key exclusion criteria (6 listed)
- Medical instability which limits ability to participate in the study (unstable vital signs, delirium, new medical events, deteriorating signs),
- Unablility to communicate in English or French,
- Behavioural issues/delirium that limit participation in the study,
- Those who have very severe dementia (using the Reisberg stage 7 which is defined by very limited communication ability, and dependence for all self-care
- Those without sufficient auditory acuity to undergo assessment and participate in the intervention, which affects their ability to communicate their consent for this study and to listen to music
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 reality (VR) music interventionThe VR music intervention consists of musical performance which were already recorded. This is accessible classic music. During the intervention, the participants will be able to see the musicians (and the stage, empty auditorium, etc.) and hear the music. | Other | VR Music- Intervention |
| Music only controlThe control group consists of the same musical performances, with the audio only | Other | Music- Active Control |
Primary outcome
Feasibility of the music VR program
Time frame: 2 Days
The recruitment goals will be met (n=30) within 6 months, attrition will be ≤ 20% for follow-up. Intervention drop-out will be ≤30% (i.e. fail to attend 50% of the intervention), and VR participants will have <1 major technical issues
Tolerability of the music VR program
Time frame: 2 days
The intervention will be acceptable and well-tolerated according to the Simulator Sickness Questionnaire (SSQ). The SSQ questionnaire consists of 16 symptoms including fatigue, headache and nausea which are rated from 0 (none) to 4 (severe). Cut-off for tolerability is < 10 over 64 years of age.
Acceptability of the music VR program
Time frame: 2 Days
Participants randomized to VR will be willing to use VR again compared to the non-VR group. This means that they will have higher presences, according to the Slater-Usoh-Steed Presence Questionnaire (SUS) score 0-100, i.e. a significantly higher SUS score compared to the non-VR group. The intervention will be acceptable to patients and won't have an impact on the clinical load of the clinical team.
2 secondary outcomes
Preliminary efficacy of the VR based music intervention in improving positive emotions
Time frame: 2 Days
Preliminary efficacy of the VR based music intervention in improving pain
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- 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.
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 (VR) music intervention in people with Older Adult and Hospitalization, run by St. Mary's Research Center, Canada at 1 site in Canada.
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 6 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Chabot, MD ((514) 345-3511 ext. 5060, Julia.chabot@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the music VR program (time frame: 2 Days). The study lists 3 primary outcomes in all. 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 25 Jul 2024.