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临床试验/NCT04176822
NCT04176822已完成不适用

The Effects of Designing an Educational Animated Movie About Preoperative Preparation on Fear and Post-Operative Pain in Children:A Randomized Controlled Trial

Ege University2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2017年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
Change of Children's Postopeartive Pain

研究概览

简要总结

Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. This study aims to investigate the effects of watching an educational animated movie in the pre-operative period on fear and postoperative pain in children who are having surgery.

Methods: The study was a prospective randomized controlled trial. This study was conducted between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical Faculty Hospital. The current study includes data from 132 children who were chosen doing block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale" and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were divided randomly into three groups as the "Educational Animated Movie Group" (EAMG), "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and Documentary Movie were screened using Virtual Reality (VR). Data were collected by the researcher in the pre-operative period. The pre-operative fear of the child was evaluated by the child and the parent, and the post-operative pain of the child was evaluated by the child, parent, and nurse using scales about fear and pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • First surgery
  • Daily surgery and uncomplicated surgery
  • Agree to participate in the study
  • Speaking Turkish

排除标准

  • Refusal to participate in the study
  • A genetic/congenital disease
  • A chronic disease
  • Second or more surgery
  • Not speaking Turkish

结局指标

主要结局

Change of Children's Postopeartive Pain

时间窗: 15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes

"Wong-Baker FACES Pain Rating Scale" This scale includes six different facial expressions and is scored between 0 and 10 ("0" is none pain, "10" is maximum pain). It is a reliable and valid measurement tool for acute pain assessment, and it does not require words or numeric value. It includes measuring and evaluating postoperative pains of children.

Change of Children's Preoperative Fear

时间窗: 15 minutes (2 measurements are made-before and after intervention)

"Children's Fear Scale" (CFS) was developed and adapted by McMurtry et al. (2011). This scale includes 5 different facial expressions. This scale, graded between 0 and 4, ("0" is none fear, "4" is maximum fear) is a reliable and valid measurement tool for assessing fear. It includes measuring and evaluating preoperative fears of children.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şeyda BİNAY YAZ

Principal Investigator, Assistant Professor, PhD

Ege University

研究点 (2)

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