Clinical trial NCT03827304: 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
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Burns
Virtual Reality
Qualitative
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Sheffield
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2019-02-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

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

Primary outcomes:
measure: Pain Scores
timeFrame: Assessed 1 time during dressing with and without VR
Secondary outcomes:
measure: Anxiety Scores
timeFrame: Assessed 1 time during dressing with and without VR
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Ivan Phelan
state: South Yorkshire
Study officials:
affiliation: Sheffield Hallam University
name: Ivan Phelan, MSc
role: PRINCIPAL_INVESTIGATOR
References: