Dr Charlotte Small
Investigation of virtual restorative environment therapy to aid pain control during dry burns dressing changes
The burns unit at the Queen Elizabeth Hospital Birmingham admits nearly 300 patients a year, including wounded military patients. The pain of a severe burn injury is characterised by an unremitting background pain, coupled with severe exacerbations associated with essential procedures such as dressing changes, staple removal from grafts and physiotherapy. A recent audit showed that 23% of patients experience moderate or severe pain during dressing changes. This study will evaluate the use of an interactive computer game, based on a virtual restorative environment (VRE), as an adjunct to pain management during burns dressing changes.The system has been developed specifically for this patient group to allow usability for all but the most severely injured patients. The study will be a single blinded (data collector only) within-subject crossover trial where patients who are undergoing dry burn dressing changes will be receive non-interactive VRE distraction, interactive VRE distraction and a control condition using standard analgesia over three consecutive dressing changes. The order of conditions will be randomised. The primary outcome will be highest pain score (numerical rating scale) during the dressing change. Secondary outcomes will be average pain scores during dressing change, pain score one hour after dressing change, anxiety, rescue analgesia, usability, level of immersion and satisfaction. Data will also be collected on staff satisfaction with and usability of the system.
More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15785
Randomised; Interventional; Design type: Not specified, Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Anaesthetics
Virtual reality (active), Interactive game, based within Virtual Wembury, whereby the patient can control movement of a speedboat viewed on a high definition screen, listening to associated sounds via headphones. The speedboat will be controlled by a single-hand use hand controller. Points can be scored by collection objects and steering between buoys.
Virtual reality (passive), Viewing of a nature based virtual world based on Wembury Bay, South Devon coastal path. The VR system consists of a high definition TV screen and headphones to provide sounds of the VR environment. The image will be viewed as if through a window, the patient will not be able to cahnge the field of view or navigate through the scene. There will be movement associated with the sea and foliage.
Primary outcome measures
Worst pain (numerical rating scale); Timepoint(s): During dressing change
Secondary outcome measures
1. Anxiety; Timepoint(s): During dressing change
2. Average pain; Timepoint(s): During dressing change
3. Nausea; Timepoint(s): During dressing change
4. Nursing satisfaction with VR system; Timepoint(s): During dressing change
5. Satisfaction with pain management; Timepoint(s): During dressing change
6. Satisfaction with VR distraction; Timepoint(s): During dressing change
7. Worst pain; Timepoint(s): One hour after dressing change
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Patients with burns (any cause) admitted to the Queen Elizabeth Hospital Burns Unit
2. Those above requiring at least three dressing changes.
3. Those above requiring opioid based analgesia (eg oral morphine, codeine phosphate or tramadol)or inhaled nitrous oxide (entonox) for the dressing change (ie, patients who may potentially experience moderate or severe pain)
Target Gender: Male & Female; Upper Age Limit 90 years ; Lower Age Limit 18 years
Target number of participants
Planned Sample Size: 25; UK Sample Size: 25
Participant exclusion criteria
1. Inability to use the interactive distraction equipment eg blindness, severe bilateral hand injuries.
2. Requirement for general anaesthesia or sedation with ketamine or midazolam.
3. Poor cognitive state eg severe dementia, delirium or severe psychiatric illness.
4. Multi-drug resistant infection (due to potential equipment contamination, although low risk, this criteria is appropriate for the feasibility study.)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Birmingham
Royal Centre for Defence Medicine (UK) Grant Codes: 20110914DMSRSGVRPLP
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26242401