Using an Interactive Virtual Reality System to Distract Burns Patients During Burn Treatments
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual Reality Distraction from Burn Pain
Sponsored by
About this trial
This is an interventional supportive care trial for Burns focused on measuring Burns, Virtual Reality, Qualitative
Eligibility Criteria
Inclusion Criteria:
- adult burns in-patients
- receiving regular dressing changes during the study period
Exclusion Criteria:
- active PTSD or psychotic symptoms
- high levels of distress
- head and neck burns
Sites / Locations
- Ivan Phelan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Burns dressings patients
Arm Description
Virtual Reality pain distraction games scenarios
Outcomes
Primary Outcome Measures
Perceptions, usability and effectiveness of VR environments in painful dressing changes
Qualitative description of patient experience; pain scores
Secondary Outcome Measures
Full Information
NCT ID
NCT03827304
First Posted
January 31, 2019
Last Updated
January 31, 2019
Sponsor
Sheffield Hallam University
Collaborators
National Institute for Health Research, United Kingdom, Sheffield Teaching Hospitals NHS Foundation Trust, University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT03827304
Brief Title
Using an Interactive Virtual Reality System to Distract Burns Patients During Burn Treatments
Official Title
The Development of Interactive Virtual Reality System to Distract Burns Patients Away From Their Pain During Clinical Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Hallam University
Collaborators
National Institute for Health Research, United Kingdom, Sheffield Teaching Hospitals NHS Foundation Trust, University of Sheffield
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
The aims and objectives of the clinical feasibility trial are:
to investigate the potential for VR to reduced perceived pain and anxiety during painful dressings changes in a small sample of burns patients;
to measure the impact of the interventions on objective indicators of pain and distress during dressing changes within the small sample
to assess pain medication use during virtual reality interventions
to compare the above effects and experiences across two conditions within each participant: an active version of a virtual reality intervention, and a 'control' condition of no intervention;
to assess the perceived usability, acceptability, engagement with and enjoyment of the virtual reality intervention to the patients
to consider the apparent feasibility of the virtual reality intervention within a Burns Unit inpatient setting during painful dressing changes 4. Design This is an exploratory feasibility study with a small clinical sample of burns patients and staff caring for them, in a single burns unit setting, employing mixed methods and a repeated measures design to achieve the aims set out above.
Detailed Description
The target sample for the clinical feasibility trial are adult burn patients (18+), who were English-speakers, and therefore able to consent for themselves to participate in the research. In order to avoid unnecessary psychological or physical distress, we excluded those with active PTSD or psychotic symptoms, or high levels of distress as judged by Burns Unit clinicians, where the use of VR might be contraindicated. People with mild-moderate or well controlled mental health problems were not be excluded from the study. In addition, those with head and neck burns were excluded as they were unable to wear the VR equipment during dressing changes. The participants were in-patients receiving regular dressing changes during the study period.
Materials used included the VR headset and the software developed using gaming environments, a booklet of questionnaires for the participants to complete, a monitor to measure heart rate, a brief interview schedule, a focus group schedule and digital recording equipment. An active (participatory) gaming environment was developed for participants to trial On three dressing change days participants were asked to complete the two 0-100 ratings 4 times - before their dressing change and three afterwards: immediately after the dressing change and then after 2 and 4 hours. They were also asked to complete the scales once on a non-dressing day after the study, to allow assessment of the impact beyond dressing days of the VR intervention. The researcher added in the dates and times for each participant in their booklet. These outcomes were selected as especially important to the study, but also to minimise participant burden. The booklet contained boxes and prompts for participants to add free text responses about the experiences we being monitoring, should they wish.
Patients were not asked during dressing changes to make any comment about their experience, so that they could concentrate on the VR environments and to avoid adding to patient burden on the non-intervention condition.
After each VR intervention dressing change, patients were asked a few questions about their experience of pain and the gaming environment, such as 'How was your pain during the dressing change while you were in the VR environment?' 'How did you feel generally during the experience?' 'How helpful did you find the VR during the dressing change?' etc. These short interviews (max 10 minutes) were recorded on a password protected digital recorder.
After both interventions, on a non-dressing change day, another short interview (max 10 minutes) was conducted to enable the participant to make comparisons between the different VR experiences and general comments about their effectiveness, usability and impact compared with no VR. Questions included 'Which VR experience did you prefer and why?' 'From your experience how does a dressing change under VR compare with one with no VR experience?' etc.
Nursing staff were interviewed in a focus group at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burns, Virtual Reality, Qualitative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study aimed to explore:
patient and staff perceptions of the effect of active and passive VR on perceived pain and anxiety during painful dressings changes;
patient perceptions of the usability, acceptability, engagement with and enjoyment of active and passive VR scenarios;
staff perceptions about the usability and implications of the VR technology within a Burns Unit inpatient setting.
Methods: This was a small-scale qualitative usability study, employing qualitative methods to intervention development and feasibility work.
Patients: Participants were adult inpatients at the local Burns Unit who were undergoing regular dressing changes during the study period. Exclusion criteria included head and neck burns, wound infection, current diagnosis of PTSD, active psychotic symptoms or high levels of distress. Suitable patients were briefly introduced to the study and supplied with a full information sheet, with details about aims, procedures and rights.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Burns dressings patients
Arm Type
Experimental
Arm Description
Virtual Reality pain distraction games scenarios
Intervention Type
Device
Intervention Name(s)
Virtual Reality Distraction from Burn Pain
Other Intervention Name(s)
Burns Dressings Patients
Intervention Description
Patients wore a VR headset while undergoing a burns dressing change
Primary Outcome Measure Information:
Title
Perceptions, usability and effectiveness of VR environments in painful dressing changes
Description
Qualitative description of patient experience; pain scores
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult burns in-patients
receiving regular dressing changes during the study period
Exclusion Criteria:
active PTSD or psychotic symptoms
high levels of distress
head and neck burns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Phelan, MSc
Organizational Affiliation
Sheffield Hallam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ivan Phelan
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S1 2NU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Using an Interactive Virtual Reality System to Distract Burns Patients During Burn Treatments
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