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NCT Number: NCT06519253

Virtual Reality Music in Geriatric Inpatients

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.

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Key information

Conditions

Older Adult Hospitalization

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Mary's Research Centre

Montreal, Quebec, H3T 0A2, Canada

Location status: Recruiting

Location contact

Harmehr Sekhon

CONTACT

[email protected]

Harmehr Sekhon, PhD

PRINCIPAL_INVESTIGATOR

Julia Chabot

CONTACT

[email protected]

Julia Chabot, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Virtual reality (VR) music intervention

Other

The 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

The control group consists of the same musical performances, with the audio only

Primary outcomes

  1. Feasibility of the music VR program

    Time frame: 2 Days

    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. Tolerability of the music VR program

    Time frame: 2 days

    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.

  3. Acceptability of the music VR program

    Time frame: 2 Days

    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.

Secondary outcomes

  1. Preliminary efficacy of the VR based music intervention in improving positive emotions

    Time frame: 2 Days

    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. Preliminary efficacy of the VR based music intervention in improving pain

    Time frame: 2 days

    Compared to the non-VR group, the VR based music group will have a greater improvement in pain, using the Visual Analog Pain Scale

Other outcomes

  1. preliminary efficacy of the VR based music intervention in improving mental well-being

    Time frame: 2 Days

    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. preliminary efficacy of the VR based music intervention in improving symptoms of anxiety

    Time frame: 2 Days

    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)

  3. preliminary efficacy of the VR based music intervention in improving symptoms of depression.

    Time frame: 2 Days

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Harmehr Sekhon, PhD

CONTACT

[email protected]

(514) 345-3511 ext. 5060

Julia Chabot, MD

CONTACT

[email protected]

(514) 345-3511 ext. 5060

Sponsors and collaborators

Lead sponsor

St. Mary's Research Center, Canada

Other

Registry information

Official study title

Virtual Reality Based Music Intervention in an Acute Geriatric Setting

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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