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临床试验/NCT07073625
NCT07073625尚未招募不适用

The Effects of Stress Ball and Storybook Reading During Inhaler Application on Fear and Anxiety in Children

Ataturk University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
99
试验地点
1
主要终点
Demographic Information Form

研究概览

简要总结

It aims to examine the effects of stress ball and book reading methods on children's fear and anxiety levels during inhalation.

详细描述

Ninety-nine volunteer children aged 5-6 who will receive inhalation therapy will be randomly assigned to three groups: stress ball, storybook reading, and control. Children will be assessed before, during, and after the procedure. Inhalation-related fear will be assessed using the Children's Fear Scale, and anxiety will be assessed using the Children's State Anxiety Scale. Furthermore, children's demographic data will be recorded on the Information Form.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •No audiovisual impairment,
  • •Being open to communication and
  • •Must be accompanied by a parent.

排除标准

  • •Having special needs,
  • •Having an audio-visual impairment,
  • •Learning difficulties or mental retardation and
  • •Children whose parents do not agree to participate in the study.

研究组 & 干预措施

Control Group

No Intervention

Routine clinical care will be applied to the control group. No action will be taken.

Experimental Group

Experimental

Children aged 5-6 who come to the emergency room with their parents and will receive inhalers will be given stress ball balls in the stress ball group before and after the procedure and will be told to play with them until the procedure is completed. In the book reading group, parents will be asked to read a book about hospital fear, prepared by researchers.

干预措施: Stress Ball (Other)

Experimental Group

Experimental

Children aged 5-6 who come to the emergency room with their parents and will receive inhalers will be given stress ball balls in the stress ball group before and after the procedure and will be told to play with them until the procedure is completed. In the book reading group, parents will be asked to read a book about hospital fear, prepared by researchers.

干预措施: Reading Storybook (Other)

结局指标

主要结局

Demographic Information Form

时间窗: Baseline

It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation. It was prepared by the researchers in line with the literature.

Child anxiety Scale-State

时间窗: Baseline and up to 4 weeks

"Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerceker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upward are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.

Child Fear Scale

时间窗: Baseline and up to 4 weeks

This scale was developed by McMurtry et al. in 2011. In 2018, Gerceker et al. carried out a Turkish validity study for the scale. The scale is aimed at children aged 5-10 years. The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces. In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points. While 0 point refers to no fear; 4 points refers to the highest fear.

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

Zülbiye demir barbak

Lecturer

Ataturk University

研究点 (1)

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