Virtual Reality Music in Geriatric Inpatients

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.

Study Overview

• Status: Recruiting
• Conditions: Hospitalization; Older Adult
• Intervention / Treatment: Other: Virtual reality (VR) music intervention; Other: Music only control

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Chabot, MD; Phone Number: 5060 (514) 345-3511; Email: Julia.chabot@mcgill.ca
• Study Contact Backup: Name: Harmehr Sekhon, PhD; Phone Number: 5060 (514) 345-3511; Email: harmehr.sekhon@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 0A2
      • Recruiting
      • St.Mary's Research Centre
      • Contact: Julia Chabot; Email: julia.chabot@mcgill.ca
      • Contact: Harmehr Sekhon; Email: harmehr.sekhon@mcgill.ca
      • Principal Investigator: Harmehr Sekhon, PhD
      • Principal Investigator: Julia Chabot, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: Music only control; The control group consists of the same musical performances, with the audio only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	2 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
preliminary efficacy of the VR based music intervention in improving mental well-being	Compared to the non-VR group, the VR based music group will have a greater improvement in well-being, anxiety and depression using the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)	2 Days
preliminary efficacy of the VR based music intervention in improving symptoms of anxiety	Compared to the non-VR group, the VR based music group will have a greater improvement in anxiety using the Generalized Anxiety Disorder-7 scale (GAD-7)	2 Days
preliminary efficacy of the VR based music intervention in improving symptoms of depression.	Compared to the non-VR group, the VR based music group will have a greater improvement in depression using the Geriatric Depression Scale (GDS-4)	2 Days

Collaborators and Investigators

• Sponsor: St. Mary's Research Center, Canada

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Estimated): November 22, 2024
• Study Completion (Estimated): May 22, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-1020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No