NCT04138095

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

October 22, 2019

Last Update Submit

March 8, 2021

Conditions

Keywords

Palliative CareVirtual RealityPainAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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

    10 days

Secondary Outcomes (1)

  • Patient perception of benefit

    10 days

Study Arms (1)

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

Device: Virtual Reality

Interventions

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

Virtual Reality

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riverview Health Centre

Winnipeg, Manitoba, R3L2P4, Canada

RECRUITING

MeSH Terms

Conditions

NeoplasmsHeart FailurePulmonary Disease, Chronic ObstructivePainAnxiety Disorders

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Officials

  • Stefan Riel, MD

    University of Manitoba Palliative Care Program

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Riel, MD

CONTACT

Zahra Moussavi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family Physician and Palliative Care Fellow

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

October 1, 2020

Primary Completion

December 31, 2020

Study Completion

March 30, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations