Virtual restorative environment therapy for burns dressing changes

ISRCTN	ISRCTN23330756
DOI	https://doi.org/10.1186/ISRCTN23330756
Protocol serial number	15785
Sponsor	University of Birmingham (UK)
Funder	Royal Centre for Defence Medicine (UK) Grant Codes: 20110914DMSRSGVRPLP

Submission date: 25/02/2014
Registration date: 25/02/2014
Last edited: 21/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Charlotte Small
Scientific

Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	c.l.flutter@talk21.com

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Not specified, Treatment
Secondary study design	Randomised controlled trial
Scientific title	Investigation of virtual restorative environment therapy to aid pain control during dry burns dressing changes
Study objectives	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.
Ethics approval(s)	13/WM/0205
Health condition(s) or problem(s) studied	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 change the field of view or navigate through the scene. There will be movement associated with the sea and foliage.
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Worst pain (numerical rating scale); Timepoint(s): During dressing change
Key secondary outcome measure(s)	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
Completion date	06/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	25
Key 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
Key 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)
Date of first enrolment	06/01/2014
Date of final enrolment	06/04/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/08/2015		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

21/11/2018: Poster reference added.