Clinical trial NCT05197894: Virtual Reality for Improving Symptoms in Palliative Care
Official title: Virtual Reality for Improving Symptoms in Palliative Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: VR experience effect on pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
timeFrame: ESAS scores measured immediately before VR experience will be compared to ESAS scores measured immediately after VR experience
Secondary outcomes:
measure: VR experience longitudinal effect (one week later) on baseline pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
timeFrame: 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.
measure: VR experience effect on Mean Arterial Pressure (MAP) (part of vital signs) as indicator for Pain and/or Distress
timeFrame: MAP measured immediately before and immediately after each VR experience.
measure: VR experience effect on Heart Rate (HR) (part of vital signs) as indicator for Pain and/or Distress
timeFrame: HR measured immediately before and immediately after each VR experience.
measure: VR experience effect on Respiratory Rate (RR) (part of vital signs) as indicator for Pain and/or Distress
timeFrame: RR measured immediately before and immediately after each VR experience.
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: The Hospice of Windsor and Essex County
state: Ontario
Study officials:
References: