跳至主要内容
临床试验/NCT07525388
NCT07525388招募中不适用

The Effect of Progressive Relaxation Exercises With Therapeutic Clown in Preoperative Period on Fear Anxiety and Physiological Parameters in Children

Ataturk University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2025年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
162
试验地点
1
主要终点
Children's Anxiety Scale

研究概览

简要总结

This study was conducted to investigate the effects of progressive relaxation exercises, performed with the assistance of a therapeutic clown during the pre-operative period, on fear, anxiety and physiological parameters in children. This randomised controlled trial included children aged 6-10 years undergoing circumcision surgery. The children were randomised into three groups: a progressive relaxation exercise group led by a therapeutic clown, a progressive relaxation group led by a nurse, and a control group. Fear, anxiety and physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation) were assessed before and after the procedure.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Aged between 6 and 10 years,
  • Willing to participate in the study,
  • Admitted to the clinic for elective circumcision surgery,
  • Accessible prior to surgery,
  • With no cognitive impairments,
  • With no vision or hearing problems were included in the study.

排除标准

  • Children who wished to withdraw from the study during the study period were excluded.

结局指标

主要结局

Children's Anxiety Scale

时间窗: up to 1 year

The Children's Anxiety Scale - State Anxiety Scale measures state anxiety in children. The CAS-S (State Anxiety) is designed in the form of a thermometer. It consists of a bulb at the bottom and horizontal lines extending upwards. Each horizontal line represents one point, and the thermometer has a total of 10 points.

Children's Fear Scale

时间窗: up to 1 year

The Paediatric Fear Scale is used to measure fear in children undergoing painful medical procedures. The Paediatric Fear Scale is a 0-4 scale featuring five faces ranging from a neutral expression (0 = no anxiety) to a fearful face (4 = severe anxiety).

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

Sümeyye EKİCİ

Research Assistant

Ataturk University

研究点 (1)

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