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临床试验/NCT06149429
NCT06149429已完成不适用

The Impact of a Novel Virtual Reality Protocol on Presence and Symptom Severity at the End-of-life.

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Edmonton Symptom Assessment System - Revised (ESAS)

研究概览

简要总结

The purpose of this research is to determine the effect that repeated, personalized virtual reality experiences have on symptom severity, comparing self-reported symptom severity both pre and post each session, and overtime across sessions. Researchers will also determine if this intervention results in a high rating of presence in VR, and if presence is related to the magnitude of the change in symptoms.

详细描述

The purpose of this research is to determine the effect that repeated, personalized virtual reality experiences have on symptom severity, comparing self-reported symptom severity both pre and post each session, and overtime across sessions. The researchers will also determine if this intervention results in a high rating of presence in VR, and if presence is related to the magnitude of the change in symptoms.

H1: Symptom severity will decrease from pre-intervention to post-intervention. H2: The change in symptom severity will be greater in session two than it was in session one.

H3: Presence score will be higher in session two than session one. To recruit 30-40 participants, the researchers will have the clinical team working to help the research team identify eligible participants from existing caseloads. Researchers will include all hospice eligible patients, this includes people who are enrolled in hospice care but also a subset of those who are enrolled in palliative care who qualify for hospice but have refused to or haven't yet transitioned to hospice care. The site serves about 670 (as of May 2023) patients a month. Therefore, it is the researcher's intent to recruit about 3 patents per month, or a total of 30-40 patients (about 5% of the monthly population) over the course of one year.

The intervention that participants will be experiencing is personalized virtual reality experiences. The content of this experience will be determined at the initial visit during which the participant will complete a preference questionnaire which identifies the location they want to "go" to. These experiences will be filmed on the insta360 One R camera by the research coordinator. Each experience will be approximately 20 minutes. To view the videos participants will wear the Oculus Quest 2 virtual reality headset.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who are hospice care eligible as defined by the Medicare Hospice benefit and receive hospice or palliative care from Hospice and Palliative Care Buffalo.

排除标准

  • Their Palliative Performance Score (PPS) is below
  • They are not cognitively intact (display symptoms of delirium or senility, or have a cognitive diagnosis such as Alzheimer's or Dementia) as measured by the Confusion Assessment Method (CAM) (Inouye et al., 1990)
  • They have hearing, vision, or speech impairments that are uncorrected.
  • They have current symptoms of or a history of dizziness, nausea, headaches, migraines, seizures, or motion sickness.
  • They do not speak English.
  • They are not 18 years old.

结局指标

主要结局

Edmonton Symptom Assessment System - Revised (ESAS)

时间窗: Two weeks

End-of-life symptom assessment

次要结局

  • igroup presence questionnaire (IPQ)(Two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Mann

Clinical Professor

State University of New York at Buffalo

研究点 (2)

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