title: A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol.
abstract: OBJECTIVE
  To report a trial protocol to determine if a therapeutic play intervention leads to significant reduction in perioperative anxiety, negative emotional manifestations and postoperative pain of children undergoing inpatient elective surgery and in their parents' perioperative anxiety.
  
  
  BACKGROUND
  Children undergoing surgery often experience anxiety, exhibit negative emotional manifestations pre-operatively and postoperative pain. Previous studies report that therapeutic play intervention has positive effects on anxiety reduction, while few studies have examined the effects of such intervention on children undergoing major elective surgery.
  
  
  METHODS
  Randomized controlled trial with repeated measures is proposed.
  
  
  METHODS
  This study will recruit 106 pairs of 6-14-year-old children undergoing elective surgery in a Singaporean public hospital and their parents (protocol approved in October 2011). Eligible participants will be randomly allocated to either a control group (receiving routine care) or an experimental group (receiving 1-hour therapeutic play intervention plus routine care). Outcome measures include children's anxiety, emotional manifestation and postoperative pain, their parents' anxiety and process evaluation. Data will be collected at baseline (3-7 days before the operation), on the day of surgery and around 24 hours after the surgery.
  
  
  CONCLUSIONS
  This study will identify a clinically useful and potentially effective approach to prepare children for surgery by reducing anxiety of both children and their parents during the perioperative period. The reduction of anxiety may lead to reduction of postoperative pain, which will eventually improve the physical and psychological well-being of children. This study was funded by the National Medical Research Council in Singapore.
authors.affiliation: Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
authors.forename: Hong Gu
authors.initials: HG
authors.lastname: He
authors.forename: Lixia
authors.initials: L
authors.lastname: Zhu
authors.forename: Ho Cheung William
authors.initials: HC
authors.lastname: Li
authors.forename: Wenru
authors.initials: W
authors.lastname: Wang
authors.forename: Katri
authors.initials: K
authors.lastname: Vehviläinen-Julkunen
authors.forename: Sally Wai Chi
authors.initials: SW
authors.lastname: Chan
mesh_terms: D000293:Adolescent; D001007:Anxiety / Q000517:prevention & control*; D002648:Child; D002673:Child, Hospitalized / Q000523:psychology; D017558:Elective Surgical Procedures / Q000009:adverse effects*; D006801:Humans; D010149:Postoperative Pain / Q000517:prevention & control*; D010290:Parents / Q000523:psychology; D010989:Play Therapy / Q000379:methods*; D016896:Treatment Outcome
keywords: anxiety; children; emotional manifestation; nursing; postoperative pain; therapeutic play intervention