title: Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The pain of a severe burn injury is often characterised by intense background pain, coupled with severe exacerbations associated with essential procedures such as dressing changes. The experience of pain is affected by patients' psychological state and can be enhanced by the anxiety, fear and distress caused by environmental and visual inputs. Virtual Reality (VR) distraction has been used with success in areas such as burns, paediatrics and oncology. The underlying principle of VR is that attention is diverted from the painful stimulus by the use of engaging, dynamic 3D visual content and associated auditory stimuli. Functional magnetic resonance imaging (fMRI) studies undertaken during VR distraction from experimental pain have demonstrated enhancement of the descending cortical pain-control system.
  
  
  METHODS
  The present study will evaluate the feasibility of introducing a novel VR system to the Burns Unit at the Queen Elizabeth Hospital Birmingham for dressing changes: virtual restorative environment therapy (VRET). The study will also explore the system's impact on pain during and after the dressing changes compared to conventional analgesia for ward-based burn dressing changes. A within-subject crossover design will be used to compare the following three conditions: 1. Interactive VRET plus conventional analgesics. 2. Passive VRET with conventional analgesics. 3. Conventional analgesics alone. Using the Monte Carlo method, and on the basis of previous local audit data, a sample size of 25 will detect a clinically significant 33 % reduction in worst pain scores experienced during dressing changes.
  
  
  CONCLUSIONS
  The study accrual rate is currently slower than predicted by previous audits of admission data. A review of the screening log has found that recruitment has been limited by the nature of burn care, the ability of burn inpatients to provide informed consent and the ability of patients to use the VR equipment. Prior to the introduction of novel interactive technologies for patient use, the characteristics and capabilities of the target population needs to be evaluated, to ensure that the interface devices and simulations are usable.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN23330756 . Date of Registration 25 February 2014.
authors.affiliation: School of Clinical and Experimental Medicine, The Medical School, Vincent Drive, University of Birmingham, Birmingham, B15 2TT, UK. c.l.flutter@talk21.com.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Small
authors.affiliation: School of Electronic, Electrical and Systems Engineering, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. r.j.stone@bham.ac.uk.
authors.forename: Robert
authors.initials: R
authors.lastname: Stone
authors.affiliation: Anaesthetic Department, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, B15 2WB, UK. janepilsbury@hotmail.com.
authors.forename: Jane
authors.initials: J
authors.lastname: Pilsbury
authors.affiliation: Anaesthetic Department, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, B15 2WB, UK. michael.bowden@uhb.nhs.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Bowden
authors.affiliation: The Medical School, Vincent Drive, University of Birmingham, Birmingham, B15 2TT, UK. j.f.bion@bham.ac.uk.
authors.forename: Julian
authors.initials: J
authors.lastname: Bion
mesh_terms: D000700:Analgesics / Q000627:therapeutic use; D001458:Bandages; D002053:Burn Units; D002056:Burns / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003201:Computers; D018592:Cross-Over Studies; D004739:England; D005240:Feasibility Studies; D006801:Humans; D015601:Injury Severity Score; D009010:Monte Carlo Method; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D059408:Pain Management / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D010147:Pain Measurement; D010865:Pilot Projects; D012107:Research Design; D018401:Sample Size; D013813:Therapy, Computer-Assisted / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D014584:User-Computer Interface; D063367:Virtual Reality Exposure Therapy / Q000295:instrumentation / Q000379:methods*
chemical_list: D000700:Analgesics