Virtual Reality Music for Aging Adults

Overseen By Harmehr Sekhon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Mary's Research Center, Canada

Disqualifiers: Delirium, Severe dementia, Ophthalmological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 days

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Virtual Reality Music for Aging Adults?

Research shows that virtual reality (VR) music therapy can be enjoyable and relaxing for older adults, potentially reducing feelings of anxiety and depression. In a study with older adults, participants reported feeling more relaxed and adventurous after using VR, and most wanted to try it again, indicating its potential benefits for well-being. ^{1 2 3 4 5}

Is Virtual Reality Music Therapy safe for aging adults?

Research shows that Virtual Reality Music Therapy is generally safe for aging adults, with most participants experiencing no negative side effects like dizziness or discomfort. Studies have found it to be feasible and well-tolerated, with participants often reporting positive experiences. ^{3 4 6 7 8}

How is Virtual Reality Music Therapy different from other treatments for aging adults?

Virtual Reality Music Therapy is unique because it uses immersive 360-degree virtual reality experiences combined with music to engage and relax older adults, potentially improving mood and reducing anxiety without the need for medication. This non-drug approach offers a safe and enjoyable way to enhance well-being, especially for those with limited mobility or cognitive impairments. ^{3 6 9 10 11}

What is the purpose of 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 is for aging adults who are currently hospitalized. It's designed to test if virtual reality (VR) music can improve mental health in older patients in acute care settings.

Inclusion Criteria

I am 60 years old 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

My health is stable enough to participate in a study.

Behavioural issues/delirium that limit participation in the study

I cannot communicate in English or French.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a 15-minute music intervention via virtual reality or headband

2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 days

Treatment Details

Interventions

• Virtual Reality Music

Trial Overview The study compares two groups: one experiencing music through immersive VR and another listening to music without VR. The goal is to see if the VR group shows greater improvements in mental well-being.

Participant Groups

Group I: VR Music- Intervention Experimental Treatment 1 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.

Group II: Music- Active Control Active Control 1 Intervention

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.

Virtual Reality Music is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Virtual Reality Music Therapy for:

• Palliative care symptom distress
• Anxiety reduction
• Pain management

Approved in European Union as VR Music Therapy for:

• Dementia care
• Alzheimer's disease management
• Cognitive rehabilitation

Approved in Canada as Immersive 360 Virtual Reality Music Intervention for:

• Geriatric mental health improvement
• Stress reduction
• Mood enhancement

Who Is Running the Clinical Trial?

St. Mary's Research Center, Canada

Lead Sponsor

Trials

11

Recruited

1,800+

Findings from Research

Immersive virtual reality (IVR) treatments showed comparable improvements in upper limb activity and daily functioning in stroke patients when compared to conventional therapy (CT), indicating its potential as an effective rehabilitation tool.

Non-immersive virtual reality (NIVR) also provided similar benefits to CT for various physical and psychological outcomes, but IVR may offer additional advantages for upper limb training, suggesting that the type of VR used can influence treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Mediated Therapies for Stroke Rehabilitation: A Systematic Review and Meta-Analysis. Mugisha, S., Job, M., Zoppi, M., et al.[2022]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

A study involving 66 older adults (average age 80.5) demonstrated that immersive Virtual Reality (VR) therapy is feasible and safe for individuals with varying cognitive and physical impairments, with no reported negative side effects.

Participants generally found the VR experience enjoyable and relaxing, with 76% expressing a desire to try it again, indicating its potential as a non-pharmacological intervention to improve well-being in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Appel, L., Appel, E., Bogler, O., et al.[2020]

A pilot study involving 23 hospitalized patients in palliative care showed that a two-day virtual reality music therapy (VR-MT) intervention was feasible and well-received, with 17 participants completing the program.

Participants reported high usability and satisfaction, with 53% giving the highest satisfaction rating, indicating that VR-MT could provide positive emotional and physical responses for patients during serious illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Music Therapy in Palliative Care: A Pilot Implementation Trial. Brungardt, A., Wibben, A., Tompkins, AF., et al.[2022]

Virtual reality (VR) shows promise as a safe and beneficial tool for stroke rehabilitation, with studies indicating positive outcomes in areas like upper limb rehabilitation, gait, and balance.

However, the overall quality of evidence is weak to moderate, with only three randomized controlled trials showing statistical significance, highlighting the need for more rigorous research to fully assess VR's effectiveness in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality in stroke rehabilitation: still more virtual than real. Crosbie, JH., Lennon, S., Basford, JR., et al.[2016]

A systematic review of 7 randomized controlled trials involving 265 older adults found that Virtual Reality (VR) training significantly improved balance and gait, as measured by the Timed Up and Go (TUG) test, with a strong effect size (Cohen's d = -0.91).

However, VR training did not show a significant impact on the Falls Efficacy Scale (FES), indicating that while balance may improve, the fear of falling may not be adequately addressed, suggesting the need for further research to refine VR training protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based balance and gait in older adults with fear of movement: A systematic review and meta-analysis. Percy, D., Phillips, T., Torres, F., et al.[2023]

The immersive virtual reality system (IVRS) was found to be safe for use among older adults, with 93.6% of participants reporting no symptoms of cybersickness and no falls or pain associated with its use.

Participants expressed high satisfaction with the IVRS after a 10-minute experience, indicating that it is a feasible option for cognitive-sensory-motor training in both fallers and nonfallers among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Tasks with Motor and Cognitive Components: A Feasibility Study of Adults and Older Adult Fallers and Nonfallers. Bacha, JMR., Pereira, GAF., Silva, IBAN., et al.[2023]

In a study involving 90 breast cancer patients, both virtual reality (VR) and music therapy (MT) were found to effectively reduce psychological distress during chemotherapy, improving mood and alleviating anxiety.

VR was shown to be more effective than MT in specifically reducing anxiety, depression, and fatigue, highlighting its potential as a powerful tool for enhancing treatment tolerance and quality of life in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy. Chirico, A., Maiorano, P., Indovina, P., et al.[2021]

The article presents a classification system for motor-cognitive interventions that utilize various digital devices, emphasizing the importance of immersive technologies like virtual reality (VR) and augmented reality (AR) in enhancing user experience and motivation for older adults.

It proposes a taxonomy of digital devices based on their level of immersiveness and human-computer interaction, highlighting the potential applications of these technologies in rehabilitation, telemedicine, and motor-cognitive training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining physical and virtual worlds for motor-cognitive training interventions: Position paper with guidelines on technology classification in movement-related research. Šlosar, L., Voelcker-Rehage, C., Paravlić, AH., et al.[2023]

A study involving 50 older adults showed that using a virtual reality (VR) environment with nature-based content significantly improved mood states, particularly feelings of 'good' and 'calm' mood, especially among participants with physical disabilities.

The research suggests that VR can be a safe and effective noninvasive method to enhance the well-being of older adults, particularly when they have limited access to real natural environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Nature-Based Virtual Reality Environment for Improving Mood States and Cognitive Engagement in Older Adults: A Mixed-Method Feasibility Study. Kalantari, S., Bill Xu, T., Mostafavi, A., et al.[2022]

Virtual reality (VR) shows promise for identifying and rehabilitating cognitive disorders in the elderly, with applications in improving navigational skills and daily living activities for patients with conditions like dementia and Parkinson's Disease.

While VR offers versatile and safer assessments, its complexity and potential side effects, such as nausea and disorientation, may pose challenges for elderly users, and current studies are limited in size and blinding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Not just fun and games: applications of virtual reality in the identification and rehabilitation of cognitive disorders of the elderly. Cherniack, EP.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Computer-Mediated Therapies for Stroke Rehabilitation: A Systematic Review and Meta-Analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Music Therapy in Palliative Care: A Pilot Implementation Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Virtual reality in stroke rehabilitation: still more virtual than real. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based balance and gait in older adults with fear of movement: A systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Immersive Virtual Tasks with Motor and Cognitive Components: A Feasibility Study of Adults and Older Adult Fallers and Nonfallers. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Combining physical and virtual worlds for motor-cognitive training interventions: Position paper with guidelines on technology classification in movement-related research. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Using a Nature-Based Virtual Reality Environment for Improving Mood States and Cognitive Engagement in Older Adults: A Mixed-Method Feasibility Study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Not just fun and games: applications of virtual reality in the identification and rehabilitation of cognitive disorders of the elderly. [2022]