Virtual Reality Music in Geriatric Inpatients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorSt. Mary's Research Center, Canada
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality (VR) music intervention
Other interventionThe 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 only control
Other interventionThe control group consists of the same musical performances, with the audio only
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: VR Music- InterventionExperimental treatment 1 intervention
Group B: Music- Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 Days2
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.
Time frame
2 days3
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.
Time frame
2 DaysSecondary outcomes
1
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
Time frame
2 Days2
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
Time frame
2 daysOther outcomes
1
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)
Time frame
2 Days2
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)
Time frame
2 Days3
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)
Time frame
2 DaysSponsors and contacts
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Source ClinicalTrials.gov