Virtual Reality Music in Geriatric Inpatients

NCT ID: NCT06519253

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2025-05-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Older Adult Hospitalization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VR Music- Intervention

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.

Group Type EXPERIMENTAL

Virtual reality (VR) music intervention

Intervention Type OTHER

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- Active Control

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.

Group Type ACTIVE_COMPARATOR

Music only control

Intervention Type OTHER

The control group consists of the same musical performances, with the audio only

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual reality (VR) music intervention

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.

Intervention Type OTHER

Music only control

The control group consists of the same musical performances, with the audio only

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.).
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Mary's Research Center, Canada

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Harmehr Sekhon, PhD

Assistant Professor and Associate Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St.Mary's Research Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julia Chabot, MD

Role: CONTACT

(514) 345-3511 ext. 5060

Harmehr Sekhon, PhD

Role: CONTACT

(514) 345-3511 ext. 5060

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julia Chabot

Role: primary

Harmehr Sekhon

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-1020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.