Virtual Reality Music in Geriatric Inpatients
NCT Number: NCT06519253
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Older Adult|Hospitalization
Interventions: OTHER: Virtual reality (VR) music intervention|OTHER: Music only control
Sponsor: St. Mary's Research Center, Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-22
Completion Date: 2025-05-22
Locations: St.Mary's Research Centre, Montréal, Quebec, H3T 0A2, Canada

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.

Primary Outcome Measures: 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: 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: 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