Virtual Reality for Improving Symptoms in Palliative Care

Not Applicable

Recruiting

• Conditions: Cancer and Non-cancer Hospice Patients
• Interventions: Device: Virtual Reality

• Registration Number: NCT05197894
• Lead Sponsor: Western University, Canada

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.

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 Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-20
• Study Start: 2023-08-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VR experience	Virtual Reality	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	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.
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.	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.

Trial Locations

Locations (1)

The Hospice of Windsor and Essex County; 🇨🇦 Windsor, Ontario, Canada