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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06149429
Other study ID # STUDY00007462
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 7, 2023
Est. completion date November 6, 2024

Study information

Verified date November 2023
Source State University of New York at Buffalo
Contact Catherine M Mann, EdD
Phone 716-829-6036
Email cmmann@buffalo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. We 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.


Description:

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. We 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, we will have our clinical team working to help the research team identify eligible participants from their caseloads. We will be including 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 6, 2024
Est. primary completion date November 6, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Healthy volunteers are not applicable to this study as they study focuses on pain and symptom management at end-of-life through the virtual reality experience. Inclusion Criteria: - 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. Exclusion Criteria: - Their Palliative Performance Score (PPS) is below 30. - 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.

Study Design


Intervention

Behavioral:
Personalized virtual reality experience
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.

Locations

Country Name City State
United States Hospice and Palliative Care Buffalo Cheektowaga New York

Sponsors (2)

Lead Sponsor Collaborator
State University of New York at Buffalo State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Edmonton Symptom Assessment System - Revised (ESAS) End-of-life symptom assessment Two weeks
Secondary igroup presence questionnaire (IPQ) Presence during virtual reality experience Two weeks
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