跳至主要内容
临床试验/NCT06519253
NCT06519253招募中不适用

Virtual Reality Based Music Intervention in an Acute Geriatric Setting

St. Mary's Research Center, Canada2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Tolerability of the music VR program

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.).

结局指标

主要结局

Tolerability of the music VR program

时间窗: 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.

Feasibility of the music VR program

时间窗: 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

Acceptability of the music VR program

时间窗: 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.

次要结局

  • Preliminary efficacy of the VR based music intervention in improving pain(2 days)
  • Preliminary efficacy of the VR based music intervention in improving positive emotions(2 Days)

研究者

发起方
St. Mary's Research Center, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Harmehr Sekhon, PhD

Assistant Professor and Associate Scientist

St. Mary's Research Center, Canada

研究点 (2)

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