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临床试验/NCT06486389
NCT06486389已完成不适用

The Effect of Reading Fairy Tales and Coloring on Children's Fear Level and Parental Health Care Satisfaction in Children Aged 3-6 Years Who Are Administered Inhaler Drugs

Trakya University2 个研究点 分布在 2 个国家目标入组 99 人开始时间: 2023年9月15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
99
试验地点
2
主要终点
Child Fear Scale

研究概览

简要总结

This thesis study was conducted as an unblinded, randomized controlled experiment to examine the effects of reading and coloring fairy tales, which can be used during inhaler medication administration with a mask, on children's fear level and parental health care satisfaction.

详细描述

Data were collected at Edirne Sultan 1. Murat State Hospital Pediatrics Clinic between September 2023 and January 2024. Children aged 3-6 were included in the study. In the research, the sample was divided into three groups. 99 children participated in the study, 33 children in each group. Using the randomization program, it was determined which sample group the children would be included in.

In the study, reading fairy tales and coloring were used as distraction methods for the experimental group. Inhaler medication was administered via mask to the control group without any application. The implementation period of the research lasted an average of four months. Necessary ethical permissions were obtained before the research. In the study, the Child Fear Scale was used to measure the level of fear, the PedsQL Health Care Satisfaction Scale was used to measure parental satisfaction, and the Children's Emotional Indicators Scale was used to measure emotional indicators. Explanatory information about the application was given to the children and their parents by the researcher, and they were voluntarily informed and signed a consent form. Research data were collected by the researcher by meeting children and parents face to face.

研究设计

研究类型
Interventional
分配方式
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

  • Parent and child volunteering to participate in the study,
  • The child is between the ages of 3-6,
  • Being admitted due to respiratory system disease,
  • Inhaler treatment with a mask will be applied.

排除标准

  • Parent and child not voluntarily participating in the study,
  • The child has any genetic, congenital, chronic or metabolic disease,
  • The child has vision, hearing and speech problems,
  • The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.

结局指标

主要结局

Child Fear Scale

时间窗: baseline

The scale was developed to determine the anxiety level of children aged 5-10 years. There are various facial expressions in the scale and a numerical value is given for each facial expression. The lowest score obtained from the scale is "0" and the highest score is "4". The higher the score obtained from the scale, the higher the level of anxiety felt in the child. The inhaler was filled by the child before medication administration.

Personal data collection form

时间窗: baseline

The data collection form was prepared by the researchers in line with the literature. In this form 8 questions about the characteristics of children.There are 18 questions in total, 10 of which include parent and family characteristics.

Child Emotional Manifestation Scale

时间窗: baseline

In the scale, emotional indicators are evaluated in terms of 5 parameters. These parameters are; facial expression, voice, activity, interaction and cooperation level. These five parameters are scored from 1 to 5, and the lowest "5" and the highest "25" points are obtained at the end of the evaluation of the scale. A low score from the scale indicates a positive emotional state, and an increase in a score indicates a negative emotional state. The inhaler was filled out by the researcher before drug administration.

次要结局

  • PedsQL Health Care Parental Satisfaction Scale(within 10 minutes after inhaler treatment)
  • Child Emotional Manifestation Scale(within 10 minutes after inhaler treatment)
  • Child Fear Scale(within 10 minutes after inhaler treatment)

研究者

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

Nuray Macuncu

Nurse

Trakya University

研究点 (2)

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