Virtual Reality at End-of-life

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149429
• Other study ID #: STUDY00007462
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Appetite Loss
• Death
• Depression
• Dyspnea
• End of Life
• Fatigue
• Nausea
• Pain

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