Contact information
Type
Scientific
Primary contact
Dr Charlotte Small
ORCID ID
Contact details
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
c.l.flutter@talk21.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15785
Study information
Scientific title
Investigation of virtual restorative environment therapy to aid pain control during dry burns dressing changes
Acronym
Study hypothesis
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
Ethics approval
13/WM/0205
Study design
Randomised; Interventional; Design type: Not specified, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Anaesthetics
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
06/01/2014
Overall trial end date
06/04/2014
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
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
06/01/2014
Recruitment end date
06/04/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Centre for Defence Medicine (UK) Grant Codes: 20110914DMSRSGVRPLP
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26242401