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Randomized Controlled Trial
. 2012 Dec 12:13:238.
doi: 10.1186/1745-6215-13-238.

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 Brown  1 , Sylvia Rodger, Robert S Ware, Roy M Kimble, Leila Cuttle
Affiliations
Randomized Controlled Trial

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 Brown et al. Trials. .

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.

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Figures

Figure 1
Figure 1
Study design flow chart. The sequential order and timing of data collection within the context of burn wound care procedures.
Figure 2
Figure 2
Patient engaging in the Ditto™ distraction phase during dressing removal. A burn patient engaging in Ditto™ distraction as nurses carry out the wound care procedures.
See this image and copyright information in PMC

References

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