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Clinical Trials/NCT05197894
NCT05197894RecruitingNot Applicable

Virtual Reality for Improving Symptoms in Palliative Care

Western University, Canada2 sites in 1 country15 target enrollmentStarted: August 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
15
Locations
2
Primary Endpoint
VR experience effect on pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 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 Respiratory Rate (RR) (part of vital signs) as indicator for Pain and/or Distress(RR measured immediately before and immediately after each VR experience.)

Investigators

Sponsor
Western University, Canada
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Patricia Valcke

Adjunct Professor, Specialist Palliative Care Consultant, Western University, Schulich School of Medicine and Dentistry

Western University, Canada

Study Sites (2)

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