Virtual Reality at End-of-life

Sponsor

State University of New York at Buffalo (Other)

Overall Status

Recruiting

CT.gov ID

NCT06149429

Collaborator

State University of New York - Upstate Medical University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
End of Life Pain Nausea Fatigue Well-Being, Psychological Depression Dyspnea Appetite Loss Anxiety	Behavioral: Personalized virtual reality experience	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group open pilot, pre- post-intervention studySingle group open pilot, pre- post-intervention study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 7, 2023

Anticipated Primary Completion Date :

Nov 6, 2024

Anticipated Study Completion Date :

Nov 6, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Edmonton Symptom Assessment System - Revised (ESAS) [Two weeks]
End-of-life symptom assessment

Secondary Outcome Measures

igroup presence questionnaire (IPQ) [Two weeks]
Presence during virtual reality experience

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.