跳至主要内容
临床试验/NCT05881941
NCT05881941已完成不适用

The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children

Eda SORKUN2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
The Wong-Baker Faces Pain Scale

研究概览

简要总结

The goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine.

详细描述

This is a randomized controlled intervention study. The research was carried out in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital Paediatrics Emergency Service between 1st May 2022 and 1st June 2022. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine. In order to collect data, Descriptive Information Form, State Trait Anxiety Inventory for Parents, Child Fear Scale and Child Emotional Indicators Scale were used. The data obtained in the study were evaluated with the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package program.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • the child should be between the ages of 3-6,
  • will receive inhaler treatment,
  • the mother or father should be with the child during the procedure,
  • not have used any sedative drugs in the last 8 hours before the application,
  • written consent has been obtained from the parents after the procedure,
  • the child is not crying before the start

排除标准

  • the child is younger than 3 years old, older than 6 years oldu,
  • the childe has a mental disability,
  • communication with the parent havinh a problem (they cannot understand and speak Turkish, etc.),
  • the child has pain,
  • the child is the terminal period,
  • the parent has a situation that prevents the assessment of the scale (mental disability, etc.)

结局指标

主要结局

The Wong-Baker Faces Pain Scale

时间窗: pre-processing

was developed by Donna Wong and Connie Morain Baker (1981) to be used to assess children's pain levels. It was revised in 1983 for assessing pain in children over the age of three (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In this scale, the pain score is determined according to the numerical values given to the various faces (Wong \& Baker, 1988; Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In our study, the researcher filled in the Wong-Baker Faces Pain Scale before the procedure in order to identify the children who were experiencing pain so that they could be excluded from the study. Only children with a pain score of "0" were taken into the study.

The Child Fear Scale (CFS)

时间窗: order of operation

was adapted by McMurty et al. (2011) from the Faces Anxiety Scale to measure anxiety in children undergoing painful medical procedures. The Child Fear Scale displays five faces with a range of expressions, from a neutral expression (0 = no anxiety) to a fearful face (4 = serious anxiety) (McMurtry et al., 2011). Permission is not required for the clinical and research usage of CFS. This scale was used in the study to determine the anxiety level of children before and during the procedure

The Children's Emotional Indicators Scale (CIAS)

时间窗: order of operation

This scale is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators of children during medical procedures.

次要结局

未报告次要终点

研究者

发起方
Eda SORKUN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eda SORKUN

principal investigator

Eskisehir Osmangazi University

研究点 (2)

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