Virtual Reality for Improving Symptoms in Palliative Care (VRPC)

May 3, 2024 updated by: Patricia Valcke, Western University, Canada
The objective of this study is to determine whether VR can ameliorate symptoms for palliative care patients within a hospice setting. We also aim to verify the efficacy with a larger sample size than previously shown, as well as extend the population to include non-cancer patients receiving Hospice care. We will further attempt to delineate whether there is a sustainability of symptomatic improvement one week after VR experiences.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Potential candidates will be provided with our assent and consent information form and the study will be explained to them in detail prior to gaining consent. As per standard practice at The Hospice of Windsor & Essex County, palliative care ESAS symptoms will be measured at baseline during the week prior to the VR experience. The mean of these pre-VR scores will be calculated as a baseline, optimally 3 separate ESAS scores in the preceding week. ESAS symptoms and expectations/satisfaction will then be measured immediately before and after the VR experience. An average set of ESAS scores will then be calculated in the same manner for one week post VR as per baseline pre-VR scores above.

We expect to find a decrease in Palliative Care symptoms after the intervention of a VR experience.

Study Type

Interventional

Enrollment (Estimated)

15

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • at least 18 years or older
  • admitted to Hospice for Specialty Palliative Care

Exclusion Criteria:

  • Palliative Performance Scale (PPS) ≤ 20%
  • severe cognitive impairment leading to inability to provide ESAS scores for 5 key symptoms measured in this study
  • severe visual and/or hearing impairment preventing use of VR (glasses and hearing aids may be worn during VR sessions and do not exclude participation)
  • absolute inability to sit
  • paralysis of an upper limb
  • participant dies before VR experience

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: VR experience
Participants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience.
Device: Virtual Reality
The intervention is a Virtual Reality experience within a selected application using an Oculus Quest 2 ©, as previously in the relevant intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VR experience effect on pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
Time Frame: ESAS scores measured immediately before VR experience will be compared to ESAS scores measured immediately after VR experience
The primary outcome of this study will be a significant difference in change of ESAS score for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) immediately before and after a VR experience.
ESAS scores measured immediately before VR experience will be compared to ESAS scores measured immediately after VR experience

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VR experience longitudinal effect (one week later) on baseline pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
Time Frame: Baseline average ESAS scores measured one week prior to the VR experience will be compared to the average of ESAS scores one week following the VR experience.
The first secondary outcome of this study will be a significant difference between the mean of the 1-week pre-VR and the mean of the 1-week post-VR ESAS scores for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being). For more objective evaluation of pain and distress we will also be measuring vitals immediately before and immediately after each VR experience.
Baseline average ESAS scores measured one week prior to the VR experience will be compared to the average of ESAS scores one week following the VR experience.
VR experience effect on Mean Arterial Pressure (MAP) (part of vital signs) as indicator for Pain and/or Distress
Time Frame: MAP measured immediately before and immediately after each VR experience.
For more objective evaluation of pain and distress, the investigators will be measuring blood pressure to compare the Mean Arterial Pressure (MAP; mmHg) immediately before and immediately after each VR experience.
MAP measured immediately before and immediately after each VR experience.
VR experience effect on Heart Rate (HR) (part of vital signs) as indicator for Pain and/or Distress
Time Frame: HR measured immediately before and immediately after each VR experience.
For more objective evaluation of pain and distress, the investigators will be measuring Heart Rate (HR; beats per minute [bpm]) immediately before and immediately after each VR experience.
HR measured immediately before and immediately after each VR experience.
VR experience effect on Respiratory Rate (RR) (part of vital signs) as indicator for Pain and/or Distress
Time Frame: RR measured immediately before and immediately after each VR experience.
For more objective evaluation of pain and distress, the investigators will be measuring Respiratory Rate (RR; breaths per minute [brpm]) immediately before and immediately after each VR experience.
RR measured immediately before and immediately after each VR experience.

Collaborators and Investigators

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

Sponsor

Western University, Canada

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)

August 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Windsor Essex Hospice VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently, there is no plan to make individual participant data (IPD) available to other researchers.

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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