Virtual Reality Music in Geriatric Inpatients

NCT06519253 | Recruiting

• 1 other identifier: 2024-1020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. However, VR based music intervention to improve older adults' mental health has not been studied in acute in-patient settings.

Conditions

Older Adult; Hospitalization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Preliminary efficacy of the VR based music intervention in improving positive emotions

  2 Days

• Preliminary efficacy of the VR based music intervention in improving pain

  2 days

Other Outcomes (3)

• preliminary efficacy of the VR based music intervention in improving mental well-being

  2 Days

• preliminary efficacy of the VR based music intervention in improving symptoms of anxiety

  2 Days

• preliminary efficacy of the VR based music intervention in improving symptoms of depression.

  2 Days

Study Arms (2)

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.

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.

Other: Music only control

Interventions

Virtual reality (VR) music intervention 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.

VR Music- Intervention

Music only control OTHER

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

Music- Active Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

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

Study Sites (1)

St.Mary's Research Centre

Montreal, Quebec, H3T 0A2, Canada

RECRUITING

Central Study Contacts

Julia Chabot, MD

CONTACT

(514) 345-3511; Julia.chabot@mcgill.ca

Harmehr Sekhon, PhD

CONTACT

(514) 345-3511; harmehr.sekhon@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Associate Scientist

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: July 25, 2024
• Study Start: May 22, 2024
• Primary Completion: November 22, 2024
• Study Completion: May 22, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)