Virtual Reality for Improving Symptoms in Palliative Care

NCT05197894 | Recruiting

• 1 other identifier: Windsor Essex Hospice VR
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer and Non-cancer Hospice Patients

Keywords

virtual reality; palliative care; Edmonton symptom assessment scale; Hospice; depression; anxiety; pain; shortness of breath; well-being

Outcome Measures

Primary Outcomes (1)

• VR experience effect on pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)

  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 Outcomes (4)

• VR experience longitudinal effect (one week later) on baseline pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)

  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

  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

  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

  RR measured immediately before and immediately after each VR experience.

Study Arms (1)

VR experience

EXPERIMENTAL

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

Interventions

Virtual Reality DEVICE

The intervention is a Virtual Reality experience within a selected application using an Oculus Quest 2 ©, as previously in the relevant intervention arm.

VR experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

The Hospice of Windsor and Essex County

Windsor, Ontario, N8T1B5, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms; Depression; Anxiety Disorders; Pain; Dyspnea

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Central Study Contacts

Patricia Valcke, MD

CONTACT

(519) 974-7100; pvalcke@thehospice.ca

Natan Veinberg, MD

CONTACT

(519)991-7050; nveinberg2021@meds.uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor, Specialist Palliative Care Consultant, Western University, Schulich School of Medicine and Dentistry

Model Details: ESAS scores for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) and qualitative question(s) will be asked verbally by one of the investigators and recorded on an ipad directly into the Qualtrics form, before and after the VR session. Vital signs (blood pressure, heart rate, respiratory rate) will also be measured before and after the VR session. 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 using Oculus Quest 2 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.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 20, 2022
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)