Elsevier

Burns

Volume 40, Issue 2, March 2014, Pages 204-213
Burns

Play and heal: Randomized controlled trial of Ditto™ intervention efficacy on improving re-epithelialization in pediatric burns

https://doi.org/10.1016/j.burns.2013.11.024Get rights and content

Abstract

Background

The relationships between pain, stress and anxiety, and their effect on burn wound re-epithelialization have not been well explored to-date. The aim of this study was to investigate the effect of the Ditto™ (a hand-held electronic medical device providing procedural preparation and distraction) intervention on re-epithelialization rates in acute pediatric burns.

Methods/Design

From August 2011 to August 2012, children (4–12 years) with an acute burn presenting to the Royal Children's Hospital, Brisbane, Australia fulfilled the study requirements and were randomized to [1] Ditto™ intervention or [2] standard practice. Burn re-epithelialization, pain intensity, anxiety and stress measures were obtained at every dressing change until complete wound re-epithelialization.

Results

One hundred and seventeen children were randomized and 75 children were analyzed (n = 40 standard group; n = 35 Ditto™ group). Inability to predict wound management resulted in 42 participants no longer meeting the eligibility criteria. Wounds in the Ditto™ intervention group re-epithelialized faster than the standard practice group (−2.14 days (CI: −4.38 to 0.10), p-value = 0.061), and significantly faster when analyses were adjusted for mean burn depth (−2.26 days (CI: −4.48 to −0.04), p-value = 0.046). Following procedural preparation at the first change of dressing, the Ditto™ group reported lower pain intensity scores (−0.64 (CI: −1.28, 0.01) p = 0.052) and lower anxiety ratings (−1.79 (CI: −3.59, 0.01) p = 0.051). At the second and third dressing removals average pain (FPS-R and FLACC) and anxiety scores (VAS-A) were at least one point lower when Ditto™ intervention was received.

Conclusions

The Ditto™ procedural preparation and distraction device is a useful tool alongside pharmacological intervention to improve the rate of burn re-epithelialization and manage pain and anxiety during burn wound care procedures.

Section snippets

Background

Burn wound pain remains insufficiently treated, despite considerable advances in burn wound management [1]. Procedural burn pain occurring from therapeutic wound care procedures, i.e. cleaning and debriding the wound, is the most intense and the most common type of burn pain to be undertreated [2]. The entire wound healing period can evoke a high level of pain, stress and anxiety, particularly in children [3], [4], [5]. Acute stress symptoms [6] and psychological disorders, including

Design and setting

This study was a prospective, parallel-group, superiority, randomized controlled trial, conducted in the Stuart Pegg Paediatric Burn Center at the Royal Children's Hospital, Brisbane, Australia [34]. The trial took place between August 2011 and August 2012. Participants were randomized using a computerized random number generator to one of two parallel groups (Fig. 1), receiving either (1) standard preparation and standard distraction (standard group), or (2) Ditto™ procedural preparation and

Results

Children presenting to the Burn Center were assessed for eligibility and 117 were consented (Fig. 1). Eighteen participants were subsequently found to be ineligible as either their burn was not substantial enough (erythema only), or because of child protection involvement. Consequently 52 children entered the standard practice group and 47 entered the Ditto group. The inability to predict patient and wound management needs prior to dressing removal (e.g. use of Entonox™; need for grafting) and

Discussion

Burn wounds of children who received the Ditto™ procedural preparation and distraction intervention re-epithelialized on average two days faster than the standard practice group. Ditto™ procedural preparation significantly reduced anxiety levels prior to the first dressing removal and the average heart rate across all change of dressings. During the second and third dressing changes, the Ditto™ group's pain and anxiety levels were on average lower than the standard practice group. This is the

Conclusion/recommendations

Future studies should investigate the effectiveness of the Ditto™ device in children with deeper burns and larger burn TBSA, to further validate the positive effects of the Ditto™ on re-epithelialization. Furthermore, based on sustained positive effects of the Ditto™ with repeated use, it may be hypothesized that the benefits of the Ditto™ strengthen when repeated, consistent procedural preparation and distraction are received, creating a sense of structure, security and diversion for the child

Conflict of interest statement

This randomized controlled trial received financial support by a grant given to the Royal Children's Hospital, Brisbane, by Diversionary Therapy Technologies (DTT). Despite this financial support, DTT had no part in the study design, data collection, and analysis of this project, nor will they have any involvement in the publication of results. One of the supervisors of the trial, Roy Kimble, holds options with DTT, however will not stand to lose or gain financially or personally from the

Authors’ contributions

NJB, LC, RMK, and SR all made substantial contributions to the design of this trial. RSW has made substantial contributions to the statistical design. NJB wrote the draft manuscript with input from LC. All authors provided critical review of the article and approved the final manuscript.

Acknowledgements

The authors would like to thank all the children and families who participated in this study and acknowledge all the staff at the Stuart Pegg Paediatric Burns Centre at Royal Children's Hospital, Brisbane, Australia for their support and assistance throughout data collection.

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