title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ACTRN12611000913976.
authors.affiliation: Centre for Children's Burns and Trauma Research, Queensland Children's Medical Research Institute, University of Queensland, Royal Children's Hospital, Brisbane, Queensland, Australia. n.brown3@uq.edu.au
authors.forename: Nadia J
authors.initials: NJ
authors.lastname: Brown
authors.forename: Sylvia
authors.initials: S
authors.lastname: Rodger
authors.forename: Robert S
authors.initials: RS
authors.lastname: Ware
authors.forename: Roy M
authors.initials: RM
authors.lastname: Kimble
authors.forename: Leila
authors.initials: L
authors.lastname: Cuttle
mesh_terms: D000208:Acute Disease; D000223:Adaptation, Psychological; D001007:Anxiety / Q000175:diagnosis / Q000191:economics / Q000517:prevention & control* / Q000523:psychology; D001458:Bandages; D002056:Burns / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D002648:Child; D002652:Child Behavior; D002675:Child, Preschool; D002985:Clinical Protocols; D034201:Computers, Handheld; D003362:Cost-Benefit Analysis; D004867:Equipment Design; D017721:Hospital Costs; D006801:Humans; D010146:Pain / Q000175:diagnosis / Q000191:economics / Q000517:prevention & control* / Q000523:psychology; D059408:Pain Management / Q000191:economics / Q000295:instrumentation* / Q000379:methods; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D011793:Queensland; D062326:Re-Epithelialization; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014584:User-Computer Interface; D014945:Wound Healing