Play and heal: Randomized controlled trial of Ditto™ intervention efficacy on improving re-epithelialization in pediatric burns☆
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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Trial registration ACTRN12611000913976.