BurnsNCT03827304
Using an Interactive Virtual Reality System to Distract Burns Patients During Burn Treatments
A study testing Virtual Reality Distraction for Burns patients in people with Burns, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
The aims are 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Virtual Reality Distraction for Burns patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult burns in-patients
- receiving regular dressing changes during the study period
Who cannot join
- active PTSD or psychotic symptoms
- high levels of distress
- head and neck burns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of Interactive Virtual Reality System to Distract Burns Patients Away From Their Pain During Clinical Interventions
The aims are 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 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.
Read the 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, the investigator 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. Participants 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. 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 the investigators being monitoring, should participants wish.
Patients were not asked during dressing changes to make any comment about their experience, so that patients 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.
- Conditions
- Burns
- Being tested
- Virtual Reality Distraction for Burns patients
- Keywords
- Burns, Virtual Reality, Qualitative
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Distraction for Burns patientsDevice
Also called Burns Dressings Change VR distraction
Patients wore a VR headset while undergoing a burns dressing change
| Study group | Role | What they receive |
|---|---|---|
| Burns patients | Experimental | This is the group of burns patients that use receive the intervention with the Virtual Reality pain distraction game during the dressing change. Receives: Device: Virtual Reality Distraction for Burns patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Using a thermometer scale (Sheffield Burns Unit Psychosocial Screening Tool). Pain was measured on a scale range 0-100 in which 0 is no pain and 100 represents the greatest levels imaginable of pain.
Measured: Assessed 1 time during dressing with and without VR
Secondary outcomes (1)
Anxiety Scores
Using a thermometer scale (Sheffield Burns Unit Psychosocial Screening Tool). Anxiety was measured on a scale range 0-100 in which 0 is no anxiety and 100 represents the greatest levels imaginable of anxiety.
Measured: Assessed 1 time during dressing with and without VR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ivan Phelan, MSc, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827304
- Sponsor's protocol ID
- AA8434
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2019
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Interactive Virtual Reality System to Distract Burns Patients Away From Their Pain During Clinical Interventions
- ClinicalTrials.gov ID
- NCT03827304
- Acronym / sponsor ID
- AA8434
- Conditions
- Burns
- Keywords
- Burns, Virtual Reality, Qualitative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Posted 11 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims are 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 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, the investigator 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. Participants 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. 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 the investigators being monitoring, should participants wish.
Patients were not asked during dressing changes to make any comment about their experience, so that patients 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Burns patients | Experimental | Device: Virtual Reality Distraction for Burns patientsThis is the group of burns patients that use receive the intervention with the Virtual Reality pain distraction game during the dressing change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult burns in-patients
- receiving regular dressing changes during the study period
Key exclusion criteria (3 listed)
- active PTSD or psychotic symptoms
- high levels of distress
- head and neck burns
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 Reality Distraction for Burns patientsAlso: Burns Dressings Change VR distractionPatients wore a VR headset while undergoing a burns dressing change | Device | Burns patients |
Primary outcome
Pain Scores
Time frame: Assessed 1 time during dressing with and without VR
Using a thermometer scale (Sheffield Burns Unit Psychosocial Screening Tool). Pain was measured on a scale range 0-100 in which 0 is no pain and 100 represents the greatest levels imaginable of pain.
1 secondary outcome
Anxiety Scores
Time frame: Assessed 1 time during dressing with and without VR
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ivan Phelan, MSc principal investigator
Sheffield Hallam University
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 Distraction for Burns patients in people with Burns, run by Sheffield Hallam University at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 25 Mar 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: Assessed 1 time during dressing with and without VR). 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 25 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.