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Open Access Study protocol

Efficacy of a children’s procedural preparation and distraction device on healing in acute burn wound care procedures: study protocol for a randomized controlled trial

Nadia J Brown1*, Sylvia Rodger2, Robert S Ware34, Roy M Kimble1 and Leila Cuttle1

Author Affiliations

1 Centre for Children’s Burns and Trauma Research, Queensland Children’s Medical Research Institute, University of Queensland, Royal Children’s Hospital, Brisbane, Queensland, Australia

2 Division of Occupational Therapy, The University of Queensland, School of Health & Rehabilitation Sciences, Brisbane, Queensland, Australia

3 The University of Queensland, Queensland Children’s Medical Research Institute, Brisbane, Queensland, Australia

4 The University of Queensland, School of Population Health, Brisbane, Queensland, Australia

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Trials 2012, 13:238  doi:10.1186/1745-6215-13-238

Published: 12 December 2012

Abstract

Background

The intense pain and anxiety triggered by burns and their associated wound care procedures are well established in the literature. Non-pharmacological intervention is a critical component of total pain management protocols and is used as an adjunct to pharmacological analgesia. An example is virtual reality, which has been used effectively to dampen pain intensity and unpleasantness. Possible links or causal relationships between pain/anxiety/stress and burn wound healing have previously not been investigated. The purpose of this study is to investigate these relationships, specifically by determining if a newly developed multi-modal procedural preparation and distraction device (Ditto™) used during acute burn wound care procedures will reduce the pain and anxiety of a child and increase the rate of re-epithelialization.

Methods/design

Children (4 to 12 years) with acute burn injuries presenting for their first dressing change will be randomly assigned to either the (1) Control group (standard distraction) or (2) Ditto™ intervention group (receiving Ditto™, procedural preparation and Ditto™ distraction). It is intended that a minimum of 29 participants will be recruited for each treatment group. Repeated measures of pain intensity, anxiety, stress and healing will be taken at every dressing change until complete wound re-epithelialization. Further data collection will aid in determining patient satisfaction and cost effectiveness of the Ditto™ intervention, as well as its effect on speed of wound re-epithelialization.

Discussion

Results of this study will provide data on whether the disease process can be altered by reducing stress, pain and anxiety in the context of acute burn wounds.

Trial registration

ACTRN12611000913976

Keywords:
Burns; Child; Pain; Stress; Anxiety; Salivary cortisol; Salivary alpha-amylase; Virtual reality; Randomized clinical trial