AgingNCT06296199
Music, Virtual Reality for Patients in IUGM
A study testing VR and Music only in people with Aging and Disorder, Neurologic, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.
Trial summary
Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Disorder, Neurologic
- What is being tested?
- VR and Music only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 23 Oct 2024
- 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
- be hospitalized at the URFI of the IUGM, or being a patients attending the geriatric outpatient clinic
- be 60 years of age or older,
- not have an acute intercurrent pathology in the week preceding the procedure and during the two days of the procedure,
- have no psycho-behavioural disorders,
- no major neurocognitive disorder at a severe stage,
- no severe visual or hearing impairment,
- no vestibular balance disorders,
- give written consent to participate in the study.
Who cannot join
- Participate in another concurrent experimental clinical study, to avoid interference with our study.
- Do not understand written or spoken French or English. The participants are French and/or English speakers, and the questionnaires are only available in these 2 languages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music, Virtual Reality and Mental Health of Inpatients in the Intensive Functional Rehabilitation Unit and Patients in the IUGM Geriatric Outpatient Clinic: Pilot Clinical Trial
Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.
Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI and in patients attending the geriatric outpatient clinic, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.
- Conditions
- Aging, Disorder, Neurologic
- Being tested
- VR, Music only
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VROther
The participant will be seated comfortably in an armchair. The intervention will last 15 minutes. It will take place once.
This group's intervention will be to watch and listen with VR headphones to a concert by a group of musicians playing music.
Music onlyOther
The participant will be seated comfortably in an armchair. The intervention will last 15 minutes. It will take place once.
This group's intervention will be to listen with conventional headphones to a concert by a group of musicians playing music.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | participants will listen to and watch a concert of musicians playing classical music through a VR headset Receives: Other: VR |
| Control | Active comparator | participants will simply listen to the concert through headphones Receives: Other: Music only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability
To determine if investigator is able to recruit 80 patients in 6 months, with a consent rate of 80% or more and less than 20% of withdrawal
Measured: 6 months
Secondary outcomes (5)
Emotions variation
To quantify and compare variations in Visual Analog Mood Scales (VAMS) score between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones).
This scale examines 8 emotions represented by ideogrammatic icons. It contains 2 positive emotions (happy and energetic) and 6 negative emotions (scared, confused, sad, angry, tired, tense). Each emotion is linked to a neutral face by a line. Participants will be asked to place a mark on the line at the point that represents the intensity of the emotion they are feeling. The distance in millimetres from the neutral face corresponds to the score (e.g., the further away from the neutral face, the greater the emotion). A higher positive emotion score means the participant feels better, and a higher negative emotion score means the patient feels worse.
Measured: 1 day
Affect variation
To quantify and compare variations in scores on Positive and negative Affect schedule (PANAS) between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones).
This positive and negative affectivity scale is a questionnaire designed to measure the valence and activation (i.e. intensity) of a person's affects. It comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20. Scores range from 10 to 50 for the negative affect score and from 10 to 50 for the positive affect score, respectively, with a low score representing the lowest levels of negative affect, and a high score representing high levels of positive affect. A high negative affect score reveals psychological distress involving a variety of unpleasant emotions, while a low score reflects calm and serenity.
Measured: 1 day
Well-Being Variation
To quantify and compare variations in scores on Warwick Edinburgh mental well-being scale measuring well-being between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones).
This scale is made up of 14 positively worded items and produces scores ranging from 14 (i.e. no well-being) to 70 (i.e. complete well-being).
Measured: 1 day
Quality of life variation
To quantify and compare variations in scores on Eq-5D scale measuring quality of life between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones).
This test is a standardized measure of health status developed by the EuroQol group to provide a simple, generic measure of health for clinical and economic evaluation. It provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of two parts: (1) a five-question questionnaire with a score per question ranging from 1 (i.e. no problem) to 5 (i.e. a more serious problem), (2) and a visual analog scale indicating how good or bad the participant's health is. This scale is numbered from 0 (i.e. the worst health the participant can imagine) to 100 (i.e. the best health the participant can imagine).
Measured: 1 day
Anxiety variation
To quantify and compare variations in scores on General Anxiety Disorder - 7 scale measuring anxiety between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones).
This is a 7-item scale (each item is rated on a Likert scale ranging from "not at all" to "almost every day"). The maximum score is 21, and the higher the score, the greater the anxiety.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 May 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Olivier Beauchet, Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296199
- Sponsor's protocol ID
- 2024-2064
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2024
- Last updated
- 11 Feb 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music, Virtual Reality and Mental Health of Inpatients in the Intensive Functional Rehabilitation Unit and Patients in the IUGM Geriatric Outpatient Clinic: Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06296199
- Acronym / sponsor ID
- 2024-2064
- Conditions
- Aging, Disorder, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 6 Mar 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.
Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.
Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI and in patients attending the geriatric outpatient clinic, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: VRparticipants will listen to and watch a concert of musicians playing classical music through a VR headset |
| Control | Active comparator | Other: Music onlyparticipants will simply listen to the concert through headphones |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- be hospitalized at the URFI of the IUGM, or being a patients attending the geriatric outpatient clinic
- be 60 years of age or older,
- not have an acute intercurrent pathology in the week preceding the procedure and during the two days of the procedure,
- have no psycho-behavioural disorders,
- no major neurocognitive disorder at a severe stage,
Key exclusion criteria (2 listed)
- Participate in another concurrent experimental clinical study, to avoid interference with our study.
- Do not understand written or spoken French or English. The participants are French and/or English speakers, and the questionnaires are only available in these 2 languages.
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 |
|---|---|---|
| VRThe participant will be seated comfortably in an armchair. The intervention will last 15 minutes. It will take place once. This group's intervention will be to watch and listen with VR headphones to a concert by a group of musicians playing music. | Other | Intervention |
| Music onlyThe participant will be seated comfortably in an armchair. The intervention will last 15 minutes. It will take place once. This group's intervention will be to listen with conventional headphones to a concert by a group of musicians playing music. | Other | Control |
Primary outcome
Feasability
Time frame: 6 months
To determine if investigator is able to recruit 80 patients in 6 months, with a consent rate of 80% or more and less than 20% of withdrawal
5 secondary outcomes
Emotions variation
Time frame: 1 day
Affect variation
Time frame: 1 day
Well-Being Variation
Time frame: 1 day
Quality of life variation
Time frame: 1 day
Anxiety variation
Time frame: 1 day
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 11 Feb 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. 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?
A study testing VR and Music only in people with Aging and Disorder, Neurologic, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal 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 8 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: finished, as of the sponsor's last update on 11 Feb 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 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?
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?
Feasability (time frame: 6 months). 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 11 Feb 2025.