- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821466
VR for Symptom Control and Wellbeing
November 20, 2023 updated by: Royal Cornwall Hospitals Trust
The Use of Virtual Reality for Symptom Control and Wellbeing in Palliative Care and Oncology Patients
To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cornwall
-
Truro, Cornwall, United Kingdom, TR1 3HD
- Royal Cornwall Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- > 18 years of age
- Inpatient at RCHT know to the palliative care team
- Able to consent
- Able to speak and understand the English language
- Able to use the virtual reality system
- Able to complete ESAS-r Questionnaire
Exclusion criteria
- <18 years of age
- Patient unable to consent
- Patient unable to speak English
- Unable to use the virtual reality system (e.g. visually impaired)
- Known Epilepsy or seizures or suspected predisposition to seizures (e.g. Brain metastasis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Headset
VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing
|
Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset.
Participants will wear the Virtual reality headset to be immersed in a multimedia experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ESAS-r Quality of Life Scores
Time Frame: Time 0 & Time 60 minutes
|
Change in ESAS-r QoL score between start and finish of Virtual Reality experience.
0 = No symptoms to 10 = Worst Symptom
|
Time 0 & Time 60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative clinician experience of VR intervention
Time Frame: Time 60 minutes
|
Clinician score of patient experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)
|
Time 60 minutes
|
|
Quantitative clinician experience of VR intervention
Time Frame: Time 60 minutes
|
Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)
|
Time 60 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative patient experience of VR interventions
Time Frame: Time 60 minutes
|
Patients to answer: Were there any negative side effects of the VR session?
|
Time 60 minutes
|
|
Repeat VR experiences
Time Frame: 12 Months
|
ESAS-r QoL Scores (0 to 10) will be collected each time a patient uses the experience to consider the effect repeat exposure has on wellbeing and symptoms.
0 = No symptoms to 10 = Worst Symptom
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Niall O Moon, BMBCh, doctor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2021
Primary Completion (Actual)
September 20, 2022
Study Completion (Actual)
September 20, 2022
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 25, 2021
First Posted (Actual)
March 29, 2021
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.RCHT.07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share patient data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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