VR + Music for Aging

Overseen By Olivier Beauchet, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Disqualifiers: Acute pathology, Neurocognitive disorder, 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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR. Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI and in patients attending the geriatric outpatient clinic, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you are not participating in another experimental clinical study.

What data supports the idea that VR + Music for Aging is an effective treatment?

The available research shows that VR and music therapy can help reduce anxiety and improve mood in breast cancer patients during chemotherapy. VR was found to be more effective than music therapy alone in reducing anxiety, depression, and fatigue. Additionally, a study on palliative care patients found that VR-based music therapy was feasible, usable, and well-received, with many participants reporting positive emotional and physical responses. These findings suggest that VR + Music for Aging could be an effective treatment for improving emotional well-being. ^{1 2 3 4 5}

What safety data exists for VR and music therapy treatments?

The studies indicate that VR and music therapy interventions are generally feasible, usable, and acceptable across various patient groups, including those in palliative care, breast cancer patients, and hospitalized children. Participants reported favorable emotional and physical responses, with high usability and acceptability scores. No specific safety concerns were highlighted, suggesting these interventions are safe for use in these contexts. ^{1 4 6 7 8}

Is the treatment Music and Virtual Reality a promising treatment for aging?

Yes, Music and Virtual Reality is a promising treatment. It has been shown to be enjoyable and helpful for patients, improving their mood and reducing anxiety. It is especially useful for people in palliative care and those undergoing chemotherapy, making them feel better emotionally and physically. ^{1 4 9 10 11}

Eligibility Criteria

This trial is for inpatients aged 60 or older at the IUGM's URFI without acute illnesses, severe cognitive impairments, major visual/hearing issues, or balance disorders. Participants must consent to the study.

Inclusion Criteria

I am currently admitted at the URFI of the IUGM.

I am 60 years old or older.

I haven't been sick with another illness in the week before and two days during the procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants will listen to and watch a concert of musicians playing classical music through a VR headset or listen to the concert through headphones

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in emotions, quality of life, anxiety, affect, and well-being after the intervention

6 months

Treatment Details

Interventions

• Music and Virtual Reality

Trial Overview The trial tests a new intervention using VR headsets and music aimed at improving mental health, well-being, quality of life and reducing anxiety in geriatric patients.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

participants will listen to and watch a concert of musicians playing classical music through a VR headset

Group II: Control Active Control 1 Intervention

participants will simply listen to the concert through headphones

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

Approved in Canada as Music and Virtual Reality Therapy for:

• Anxiety reduction
• Improvement of mental health
• Enhancement of well-being and quality of life in geriatric patients

Approved in European Union as Music Therapy and Virtual Reality for:

• Palliative care
• Alzheimer's disease management
• Cognitive rehabilitation
• Pain management

Approved in United States as Virtual Reality and Music Therapy for:

• Pain management
• Anxiety reduction
• Improvement of mental health in hospitalized patients

Who Is Running the Clinical Trial?

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Lead Sponsor

Trials

15

Recruited

24,400+

Findings from Research

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]

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]

In a study involving 20 stroke survivors, multiuser virtual reality (MU VR) therapy led to significantly greater arm movement (414.6m) compared to single-user (SU VR) therapy (327.0m), indicating that MU VR may enhance physical engagement during rehabilitation.

Participants showed high compliance with both therapy modes (99% for MU and 89% for SU), and overall motor recovery, as measured by the Fugl-Meyer Assessment, improved significantly across all participants, suggesting that MU VR can effectively extend clinical therapy into home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Thielbar, KO., Triandafilou, KM., Barry, AJ., 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]

A 6-session trial with 25 aged care residents showed that group-based immersive virtual reality (VR) significantly reduced depressive symptoms and apathy, while improving participants' pleasure and alertness.

The VR sessions were well-tolerated with minimal side effects, indicating that this innovative approach could be a feasible option for enhancing the emotional well-being of cognitively diverse residents in aged care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Group-Based Multiple Virtual Reality Sessions to Reduce Behavioral and Psychological Symptoms in Persons Living in Residential Aged Care. Brimelow, RE., Thangavelu, K., Beattie, R., et al.[2022]

In a study involving 19 hospitalized children and adolescents with chronic illnesses, those receiving virtual reality treatment reported significantly higher perceived efficacy and acceptability compared to traditional cognitive-behavioral therapy.

The virtual reality program was well-received, showing high scores in immersion and feasibility, suggesting that technology-based treatments can enhance motivation and engagement in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Emotional Well-being in Hospitalized Children and Adolescents With Virtual Reality: Usability and Acceptability of a Randomized Controlled Trial. Flujas-Contreras, JM., Ruiz-Castañeda, D., Gómez, I.[2021]

In a study of 275 patients undergoing third-molar extraction, both music therapy and virtual reality (VR) significantly reduced anxiety levels compared to a control group, with music therapy showing a greater reduction in anxiety scores.

Patients who received music therapy experienced lower pain intensity after surgery compared to the control group, and both music and VR interventions led to significant decreases in blood pressure and heart rate, indicating improved physiological responses during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of virtual reality and music therapy on anxiety and perioperative pain in surgical extraction of impacted third molars. Sorribes De Ramón, LA., Ferrández Martínez, AF., García Carricondo, AR., et al.[2023]

The study developed an auditory-visual interactive virtual reality environment specifically designed to treat cynophobia (fear of dogs), utilizing 3D sound to enhance the experience.

Testing with 10 participants revealed that the virtual environment effectively generated fear reactions, indicating its potential as a promising treatment tool for cynophobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory-visual virtual reality as a diagnostic and therapeutic tool for cynophobia. Suied, C., Drettakis, G., Warusfel, O., et al.[2016]

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]

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]

References

1. 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]

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

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

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

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. [2020]

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

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

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

Feasibility of Group-Based Multiple Virtual Reality Sessions to Reduce Behavioral and Psychological Symptoms in Persons Living in Residential Aged Care. [2022]

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

Promoting Emotional Well-being in Hospitalized Children and Adolescents With Virtual Reality: Usability and Acceptability of a Randomized Controlled Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effect of virtual reality and music therapy on anxiety and perioperative pain in surgical extraction of impacted third molars. [2023]

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

Auditory-visual virtual reality as a diagnostic and therapeutic tool for cynophobia. [2016]

9. 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]

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

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

11. 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]