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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial

Authors: Charlotte Small, Robert Stone, Jane Pilsbury, Michael Bowden, Julian Bion

Published in: Trials | Issue 1/2015

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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/Design

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.

Discussion

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.

Trial registration

Current Controlled Trials ISRCTN23330756. Date of Registration 25 February 2014.
Footnotes
1
Immersion is the term used to describe the amount of stimulation imposed by the VR system on the body’s sensory inputs. Increased immersion can be achieved, for example, by use of haptic feedback systems. Presence is the term used to describe the psychological consequence of technological immersion; the sensation of ‘being there’ within the virtual environment.
 
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Metadata
Title
Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial
Authors
Charlotte Small
Robert Stone
Jane Pilsbury
Michael Bowden
Julian Bion
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0878-8

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