CancerNCT04138095
Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care
A study testing Virtual Reality in people with Cancer and Heart Failure, run by Riverview Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Heart Failure, Copd
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Participants who cannot tolerate the HMD and VR due to simulator sickness will have to be withdrawn from the study by the investigator.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Riverview Health Centre
Winnipeg, Manitoba, R3L2P4
Stefan Riel, MD, 204-803-5051, sljriel@gmail.com
About this study
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
Read the 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.
- Conditions
- Cancer, Heart Failure, Copd, ALS
- Being tested
- Virtual Reality
- Keywords
- Palliative Care, Virtual Reality, Pain, Anxiety
- Medical subject headings
- Neoplasms, Heart Failure, Pulmonary Disease, Chronic Obstructive, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Other | 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 Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (1)
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within subject design
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riverview Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Riverview Health Centre Foundation
- Responsible party
- Principal investigator, Stefan Riel, Riverview Health Centre
- Investigators
- Stefan Riel, MD, Principal investigator, University of Manitoba Palliative Care Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138095
- Sponsor's protocol ID
- RiverviewHC
- Status last verified
- Mar 2021
- First submitted
- 22 Oct 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care
- ClinicalTrials.gov ID
- NCT04138095
- Acronym / sponsor ID
- RiverviewHC
- Conditions
- Cancer, Heart Failure, Copd, ALS
- Keywords
- Palliative Care, Virtual Reality, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Riverview Health CentreUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Riverview Health Centre Foundation
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subject design
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Other | Device: Virtual RealityAs 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityParticipants 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 | Device | Virtual Reality |
Primary outcome
Opioid and Benzodiazepine use
Time frame: 10 days
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
1 secondary outcome
Patient perception of benefit
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Riel, MD principal investigator
University of Manitoba Palliative Care Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Cancer and Heart Failure, run by Riverview Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Riel, MD (204-803-5051, sriel@wrha.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid and Benzodiazepine use (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.