Clinical trial NCT06519253: Virtual Reality Music in Geriatric Inpatients
Official title: Virtual Reality Based Music Intervention in an Acute Geriatric Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older Adult
Hospitalization
Lead sponsor: St. Mary's Research Center, Canada
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Feasibility of the music VR program
timeFrame: 2 Days
measure: Tolerability of the music VR program
timeFrame: 2 days
measure: Acceptability of the music VR program
timeFrame: 2 Days
Secondary outcomes:
measure: Preliminary efficacy of the VR based music intervention in improving positive emotions
timeFrame: 2 Days
measure: Preliminary efficacy of the VR based music intervention in improving pain
timeFrame: 2 days
Other outcomes:
measure: preliminary efficacy of the VR based music intervention in improving mental well-being
timeFrame: 2 Days
measure: preliminary efficacy of the VR based music intervention in improving symptoms of anxiety
timeFrame: 2 Days
measure: preliminary efficacy of the VR based music intervention in improving symptoms of depression.
timeFrame: 2 Days
Locations:
city: Montréal
country: Canada
facility: St.Mary's Research Centre
state: Quebec
Study officials:
References: