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一项关于治疗性游戏干预对接受住院择期手术儿童结局有效性的随机对照试验:研究方案。

A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol.

作者信息

He Hong Gu, Zhu Lixia, Li Ho Cheung William, Wang Wenru, Vehviläinen-Julkunen Katri, Chan Sally Wai Chi

机构信息

Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

出版信息

J Adv Nurs. 2014 Feb;70(2):431-42. doi: 10.1111/jan.12234. Epub 2013 Aug 29.

DOI:10.1111/jan.12234
PMID:23991679
Abstract

AIM

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.

DESIGN

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.

DISCUSSION

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.

摘要

目的

报告一项试验方案,以确定治疗性游戏干预是否能显著降低接受住院择期手术儿童的围手术期焦虑、负面情绪表现和术后疼痛以及其父母的围手术期焦虑。

背景

接受手术的儿童通常会经历焦虑,在术前表现出负面情绪,术后疼痛。以往研究报告称,治疗性游戏干预对减轻焦虑有积极作用,但很少有研究考察这种干预对接受大型择期手术儿童的影响。

设计

建议采用重复测量的随机对照试验。

方法

本研究将招募106对在新加坡一家公立医院接受择期手术的6至14岁儿童及其父母(方案于2011年10月获批)。符合条件的参与者将被随机分配到对照组(接受常规护理)或试验组(接受1小时治疗性游戏干预加常规护理)。结局指标包括儿童的焦虑、情绪表现和术后疼痛、其父母的焦虑以及过程评估。数据将在基线期(手术前3至7天)、手术当天和手术后约24小时收集。

讨论

本研究将确定一种临床有用且可能有效的方法,通过减少儿童及其父母在围手术期的焦虑,为儿童手术做好准备。焦虑的减轻可能会导致术后疼痛减轻,最终改善儿童的身心健康。本研究由新加坡国家医学研究理事会资助。

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