Virtual Reality at End-of-life

November 20, 2023 updated by: Catherine Mann, State University of New York at Buffalo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Arm Open Pilot
Pre- Post-intervention design. 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edmonton Symptom Assessment System - Revised (ESAS)
Time Frame: Two weeks
End-of-life symptom assessment
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
igroup presence questionnaire (IPQ)
Time Frame: Two weeks
Presence during virtual reality experience
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

State University of New York - Upstate Medical University

Investigators

  • Principal Investigator: Catherine Mann, EdD, SUNY Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Estimated)

November 6, 2024

Study Completion (Estimated)

November 6, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the sensitive nature of the study population at end-of-life and small sample size we feel that it poses undue risk for harm due to potential for anonymity being compromised.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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