Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001091594
Ethics application status
Approved
Date submitted
23/05/2024
Date registered
10/09/2024
Date last updated
10/09/2024
Date data sharing statement initially provided
10/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Reality intervention for burns dressing changes; efficacy, implementability and predictors of success.
Scientific title
Virtual Reality intervention for burns dressing changes in adult inpatients; efficacy at reducing pain, implementability and predictors of success.
Secondary ID [1] 311280 0
RGS0000006545
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns dressing change pain 332519 0
Condition category
Condition code
Injuries and Accidents 329204 329204 0 0
Burns
Public Health 331555 331555 0 0
Health service research
Anaesthesiology 331556 331556 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be present in the Liminal VR (https://liminalvr.com/) environment or the Furness et al. (2019) basketball simulation, previously shown to be effective in burns patients and healthy controls undergoing cold pressor stimulation (Phelan et al., 2019). They will do so using a Meta Quest 3 headset with the addition of an Elite head strap for additional stability and comfort. A pilot period will determine how these Virtual Reality (VR) experiences will work with patients and how the length of dressing change may impact what can be delivered. As the length of burns inpatient dressings are dependent on size of burn and complexity of dressing the duration of each VR session will be recorded. Each session will be monitored by the lead researcher in conjunction with burns nursing staff to ensure patient adherence to the intervention.

To assess how immersive patients found the VR experience to be (a key indicator of effective VR intervention) a brief 5 question VR immersiveness scale will be given after the intervention to assess how patients experienced the VR world they were in. The Slater-Usoh-Steed (Slater et al., 1994; SUS) questionnaire will be used as it is brief and has been shown previously to be a good measure of presence in a VR world (Nystad & Sebok, 2004).

Procedures
Participants in both groups who are not part of the exclusion criteria will be approached prior to their second dressing change, likely the previous afternoon when there is a break in their other multidisciplinary treatments such as physio exercises. At this point they will be asked if they would like to participate in their randomised group, VR or treatment as usual (control). Potential participants will be given some time to consider, should they agree to participate the relevant consent form will then be completed. The VR group will then be offered a brief 5-10 minute trial of the VR program, and asked if they experienced any symptoms of nausea, vertigo or motion sickness. If they do experience these symptoms, they will be excluded. This trial period will also serve as a calibration point to ensure best fit and vision whilst in the VR environment. Participants will be asked to complete the Multidimensional Health Locus of Control (MHLC) or Internal-External 4 scale (IE-4) the brief-COPE scale and the general self-efficacy (GSE) scale. Patients will then be informed of the plan for intervention during their next dressing change and how the intervention will be employed to assist with their intra-dressing change pain.

At the second dressing change, participants will be provided with their standard pre-dressing analgesia approximately 30 minutes prior to the onset of their dressing. Depending on day, patients may be showered before their in-bed dressing change. As the VR equipment is not waterproof, VR will be provided to the patient after showering prior to full dressing change. Typically, patients will be set up with the VR headset during their 30 minutes of waiting for analgesia to take effect. During this waiting period, an initial baseline Visual Analogue Scale (VAS) will be conducted to establish patients' pain prior to any additional stimuli (showering/dressing removal etc.). Once the patient has entered the VR environment, nurses will perform their standard dressing change procedure. Patients are able to use Entonox (on demand breakthrough analgesia; 50% oxygen in nitrous oxide; inhaled through hand-held tube) as needed (when patient requires additional pain control, or when senior burns nurses suggest they may require it) in both control and intervention groups. At the conclusion of the dressing, patients will remove the VR headset and once again be asked to complete a VAS for their pain. They will then be asked to complete the Burn Specific Pain Anxiety Scale (BSPAS) and SUS questionnaire. Patients in the control group will follow the same general procedure excepting the VR immersion scale and the VR itself.

Based on senior nurse reported averages, 3-4 dressing changes are carried out daily on the Burns ward. Consequently, this may necessitate the lead researcher being unable to stay in the room for the full duration of a session in order to facilitate another VR participant or collect control measures. As patients can often be fatigued by dressing changes, post-dressing measures will be recorded as soon as the patient is able to complete them.

Repeated measure
At the conclusion of their dressing change, the VR group will be asked if they would like to continue using VR as part of their dressing changes. If they do not wish to continue they will only have data from one dressing recorded and nil further experimental intervention. Participants continuing with VR during their dressing change will have the procedure and measures above repeated at each subsequent dressing change, and results recorded. Consequently, this trial will continue to measure standard dressing change pain and anxiety over time to see if there is a continued benefit to using VR compared to standard care. The state adult burns service has an average of 4.8 dressings recorded per inpatient admission, giving this project the ability to see if VR’s analgesic effects persist across up to 4 dressings (not including first).

Due to researcher availability, there will most likely be some patients in both control and VR groups who will undergo dressing changes on weekends, and that their data will not be able to be collected at this time. We acknowledge the limitation this imposes and will inform patients at the first consent that this may occur.

At each patient's routine six-week post discharge consultant clinic appointment they will be provided a debrief pack informing them that they were part of a wider trial, with intervention and control groups.
Intervention code [1] 327729 0
Treatment: Devices
Comparator / control treatment
The current best practice in the WA state adult burns unit will be used as an active control group. In a dressing change this often involves using music as a distraction for the patient, selected from the hospital's Patient Entertainment System (PES). Patients are also able to use Entonox (on demand breakthrough analgesia; 50% oxygen in nitrous oxide; inhaled through hand-held tube) as needed (when patient requires additional pain control, or when senior burns nurses suggest they may require it) in both control and intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 337045 0
Pain
Timepoint [1] 337045 0
Before, during, and after dressing change. Patients will have their pain recorded at 30 minutes prior to start of dressing change at the same time as initial analgesia is administered. They will then be asked to complete the VAS at a standard break in the middle of the dressing (usually for medical review and medical photography). At the conclusion of the dressing patients can often be fatigued but will be asked to complete VAS and other scales as soon as they are able.
Secondary outcome [1] 430460 0
Locus of control
Timepoint [1] 430460 0
Before first intervention/control dressing change and at discharge
Secondary outcome [2] 430461 0
Self Efficacy
Timepoint [2] 430461 0
Before first intervention/control dressing change and at discharge
Secondary outcome [3] 430462 0
Coping strategies
Timepoint [3] 430462 0
Before first intervention/control dressing change and at discharge
Secondary outcome [4] 430463 0
Pain anxiety
Timepoint [4] 430463 0
After each dressing change
Secondary outcome [5] 430464 0
Virtual Reality immersion
Timepoint [5] 430464 0
After each dressing change.
Secondary outcome [6] 439384 0
Locus of control - attitude to healthcare
Timepoint [6] 439384 0
Before first intervention/control dressing change and at discharge
Secondary outcome [7] 439575 0
Analgesia consumption
Timepoint [7] 439575 0
At each dressing and across the patient admission.

Eligibility
Key inclusion criteria
• Admitted to the burns ward and will be staying for more than one dressing change
• 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Admitted to the ICU ward
• Burn injuries in areas that a VR headset would impair nursing staff’s abilities to do dressing, or would cause pain to the patient (i.e. deep scalp/face burns)
• A visual/hearing impairment too significant to correct
• If they experience any symptoms of nausea/vertigo in VR during a brief pre-dressing trial
• Unable to speak English and a translator is unavailable

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised by computer - centralised in RedCap database/experiment manager.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations based on results of a paediatric randomised control trial for VR during dressing changes (Kipping et al., 2012) showed 30 participants would be required in each group for between-group analysis, with 80% power, a 5% Type I error rate, and a 1.5-point reduction on a 10-point Visual Analogue Scale (VAS).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/09/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
7/04/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25978 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 41829 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 315536 0
University
Name [1] 315536 0
Murdoch University
Country [1] 315536 0
Australia
Primary sponsor type
Individual
Name
Andrew Frank - Fiona Stanley Hospital - State Adult Burns Unit
Address
State Adult Burns Unit, 11 Robin Warren Dr, Murdoch 6150
Country
Australia
Secondary sponsor category [1] 317619 0
University
Name [1] 317619 0
Murdoch University
Address [1] 317619 0
90 South St, Murdoch 6150
Country [1] 317619 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314434 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 314434 0
Ethics committee country [1] 314434 0
Australia
Date submitted for ethics approval [1] 314434 0
30/01/2024
Approval date [1] 314434 0
19/03/2024
Ethics approval number [1] 314434 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131570 0
Mr Andrew Frank
Address 131570 0
State Adult Burns Unit, Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch 6150, WA
Country 131570 0
Australia
Phone 131570 0
+61 08 6152 0304
Fax 131570 0
Email 131570 0
[email protected]
Contact person for public queries
Name 131571 0
Andrew Frank
Address 131571 0
State Adult Burns Unit, Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch 6150, WA
Country 131571 0
Australia
Phone 131571 0
+61 08 6152 0304
Fax 131571 0
Email 131571 0
[email protected]
Contact person for scientific queries
Name 131572 0
Andrew Frank
Address 131572 0
State Adult Burns Unit, Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch 6150, WA
Country 131572 0
Australia
Phone 131572 0
+61 08 6152 0304
Fax 131572 0
Email 131572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.