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Clinical Trials/NCT06149429
NCT06149429
Completed
Not Applicable

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

State University of New York at Buffalo1 site in 1 country9 target enrollmentOctober 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End of Life
Sponsor
State University of New York at Buffalo
Enrollment
9
Locations
1
Primary Endpoint
Edmonton Symptom Assessment System - Revised (ESAS)
Status
Completed
Last Updated
last year

Overview

Brief 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. 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.

Detailed 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. 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.

Registry
clinicaltrials.gov
Start Date
October 23, 2023
End Date
July 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Mann

Clinical Professor

State University of New York at Buffalo

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Edmonton Symptom Assessment System - Revised (ESAS)

Time Frame: Two weeks

End-of-life symptom assessment

Secondary Outcomes

  • igroup presence questionnaire (IPQ)(Two weeks)

Study Sites (1)

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