Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care
Primary Purpose
Cancer, Heart Failure, Copd
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Palliative Care, Virtual Reality, Pain, Anxiety
Eligibility Criteria
Inclusion Criteria:
- Enrolled on the palliative care program and admitted to Riverview Health Centre Palliative Care unit
- Using 2 or more doses above their regular scheduled dose of opioids and/or benzodiazepines
- Reading/understanding fluency in English
Exclusion Criteria:
- Patients who cannot wear the headset due to a structural cause (i.e. head and neck malignancy making wearing headset uncomfortable
- Patients who are legally blind
- Participants who cannot tolerate the HMD and VR due to simulator sickness will have to be withdrawn from the study by the investigator.
Sites / Locations
- Riverview Health CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Virtual Reality
Arm Description
As this is a within subject design, participants will act as their own control. Participants will have access to their baseline opioids and benzodiazepines for pain and anxiety. Every second day they will have access to virtual reality as an adjunct to their opioids and benzodiazepines to manage their symptoms
Outcomes
Primary Outcome Measures
Opioid and Benzodiazepine use
Number of additional doses of opioids and benzodiazepines used on standard of care days will be compared to additional doses of opioids and benzodiazepines used on standard of care and virtual reality days
Secondary Outcome Measures
Patient perception of benefit
Patient will be asked to complete a Visual Analogue Scale for pain (scale from 0 to 10, 0 being no pain and 10 being worse pain imaginable) and and/or Visual Analogue Scale for anxiety (scale from 0 to 10, 0 being no anxiety/calm and 10 being extremely anxious/fearful) immediately prior to virtual reality use and immediately after use. The two values will be compared
Full Information
NCT ID
NCT04138095
First Posted
October 22, 2019
Last Updated
March 8, 2021
Sponsor
Riverview Health Centre
Collaborators
Centre for Aging and Brain Health Innovation, Riverview Health Centre Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04138095
Brief Title
Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care
Official Title
Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riverview Health Centre
Collaborators
Centre for Aging and Brain Health Innovation, Riverview Health Centre Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Virtual reality has been shown to be an effective way to treat pain and anxiety in various different settings. Palliative care is an area of medicine that often deals with patients suffering from pain and anxiety. The medication used to manage these symptoms are often opioids and benzodiazepines due to their rapid onset however they do have a significant side effect burden on patients. Very few studies have looked at the effect of virtual reality in this patient population. The goal of this study is to measure if virtual reality can decrease the required amount of medication used in managing pain and anxiety in palliative care. The secondary outcome will look at perceived benefit by patients
Detailed Description
Virtual reality has been available for many years and is starting to gain traction in clinical setting in varied fields with multiple applications. Some of the primary clinical settings that virtual reality has shown benefit are in pain attenuation and mental health, particularly anxiety. Palliative Care is a field of medicine that most patients have both pain and anxiety to a certain degree. The medications used to manage this (opioids, benzodiazepines) are used but not without side effects to the patient as well as cost to the medical system. So far, there are very few studies looking at the effect of virtual reality on symptom burden in palliative care. The primary outcome of this study would be to look at virtual reality's role in decreasing breakthrough opioids use for pain and benzodiazepine use for anxiety by decreasing symptoms experienced by patients by providing them with an immersive computer generated experience. The secondary outcome of this study will be patient's perception of symptoms with the use of virtual reality.
Virtual reality has been shown to be effective in many areas of medicine, particularly in pain management and mental health. Studies utilizing VR in pain management have commonly been done with burn victims, as burns are thought to be among the most painful injuries people sustain. Using a within subject design where the patient is his/her own control, these studies have shown an observable benefit in decreasing pain as well as cutting down on the opioid doses required to get analgesia in patients requiring wound debridement and physiotherapy in both adults and children. The investigator's patient population in palliative care is susceptible to painful metastases, pressure ulcers, and other causes of pain, which are comparable to pain experienced by burn victims. Therefore, the results of theses studies are relevant and may prove beneficial for patients receiving palliative care.
In this study, patients will receive alternating days of standard palliative care and standard palliative care with virtual reality as an option for symptom management for a total of 4-10 days. Patients will be randomized to start with standard care with virtual reality or start with standard care alone. The immersive virtual reality experience would be delivered through an Oculus Quest. There will be 3 different software options that can be used based on preference. Patients will be asked the degree of pain/anxiety prior to applying the virtual reality headset and then the same scale immediately after indicating their pain/anxiety during the experience. After the 4-10 days, breakthrough use of opioids and benzodiazepines during days with standard care and virtual reality will be compared to breakthrough use with standard care alone.
It is anticipated that the use of virtual reality will decrease the amount of medication necessary to manage symptoms of pain and/or anxiety. It is also anticipated that this will provide the patient with a pleasant respite from their symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Heart Failure, Copd, ALS
Keywords
Palliative Care, Virtual Reality, Pain, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Within subject design
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality
Arm Type
Other
Arm Description
As this is a within subject design, participants will act as their own control. Participants will have access to their baseline opioids and benzodiazepines for pain and anxiety. Every second day they will have access to virtual reality as an adjunct to their opioids and benzodiazepines to manage their symptoms
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
Participants will have access to an Oculus Quest Virtual Reality Headset every second day as an alternative to opioids for pain management and benzodiazepines for anxiety management
Primary Outcome Measure Information:
Title
Opioid and Benzodiazepine use
Description
Number of additional doses of opioids and benzodiazepines used on standard of care days will be compared to additional doses of opioids and benzodiazepines used on standard of care and virtual reality days
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Patient perception of benefit
Description
Patient will be asked to complete a Visual Analogue Scale for pain (scale from 0 to 10, 0 being no pain and 10 being worse pain imaginable) and and/or Visual Analogue Scale for anxiety (scale from 0 to 10, 0 being no anxiety/calm and 10 being extremely anxious/fearful) immediately prior to virtual reality use and immediately after use. The two values will be compared
Time Frame
10 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled on the palliative care program and admitted to Riverview Health Centre Palliative Care unit
Using 2 or more doses above their regular scheduled dose of opioids and/or benzodiazepines
Reading/understanding fluency in English
Exclusion Criteria:
Patients who cannot wear the headset due to a structural cause (i.e. head and neck malignancy making wearing headset uncomfortable
Patients who are legally blind
Participants who cannot tolerate the HMD and VR due to simulator sickness will have to be withdrawn from the study by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Riel, MD
Phone
204-803-5051
Email
sriel@wrha.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Zahra Moussavi, PhD
Phone
204-474-7023
Email
Zahra.Moussavi@Umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Riel, MD
Organizational Affiliation
University of Manitoba Palliative Care Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L2P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Riel, MD
Phone
204-803-5051
Email
sljriel@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care
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