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临床试验/NCT06512857
NCT06512857已完成不适用

The Effect of Hand Puppets and Kaleidoscope on Pain and Fear in Preschool Children Who Had Skin Prick Tests in the Pediatric Allergy and Immunology Polyclinic

Firat University2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2024年5月10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
75
试验地点
2
主要终点
WONG-BAKER FACES PAIN RATING SCALE

研究概览

简要总结

This study aimed to determine the effects of hand puppets and kaleidoscopes on some emotional parameters in preschool children who underwent skin prick testing at the pediatric allergy and immunology outpatient clinic.The study was conducted with children aged 3-6 years who underwent skin prick testing for allergy testing.In the study, the Introductory Characteristics of Children and Their Families Form, Wong-Baker Faces Pain Rating Scale (FACES) and Child Fear Scale (CFS) were used to store data.The data were uploaded to the computer and coded by the researchers, and the data were evaluated in the SPSS package program. Sociodemographic data of the children participating in the study are given as numbers and percentage distributions. The data were analyzed according to normal distribution and appropriate tests were used. The statistical significance level of the research was determined as p<0.05. In addition, at the end of the study, with a sufficient sample size, working status was tested with post-hoc power analysis.

详细描述

Type of Research: It is a randomized controlled type research. Place and Characteristics of the Research: It was conducted in the pediatric allergy and immunology outpatient clinic of Fırat University Hospital, with children aged 3-6 years who underwent skin testing for allergy. Children are accompanied by a companion during their examinations. In the routine, no distraction method is used for children during the procedure.

Allocation into groups was done using simple random sampling. Collection of data Study data were collected in 3 groups. Hand puppet group: The hand puppet was used to divert the attention of the children in the group during the skin prick test. The cost of the hand puppet was covered by the researcher.

Kaleidoscope group: It was used to divert the attention of the children in the kaleidoscope group during the skin prick test. Kaleidoscope, also known as a kaleidoscope, is a play tool that multiplies the outside image when viewed inside. The cost of the kaleidoscope was covered by the researcher.

Control group: No intervention was made to the children in the control group during the skin prick test.

  1. In the first stage, randomization of children who met the research criteria was performed.
  2. The "Introductory Characteristics Form for Children and Their Families" was filled in for the children assigned to the groups.
  3. After the children's doctor's examination at the pediatric allergy and immunology outpatient clinic, the child and his/her family, for whom a skin prick test was requested, were evaluated in the room where the test would be performed. The children in the hand puppet group were started to play games with the hand puppet by the researcher 1 minute before the procedure. During the procedure, the children in the kaleidoscope group were asked to look inside the kaleidoscope and describe the shapes they saw, thus drawing their attention to the shapes in the kaleidoscope. No application was made to the children in the control group during the skin prick test. Children, their families and the observer were asked to answer the "Wong-Baker Faces Pain Rating Scale (FACES)" and "Child Fear Scale (CFS)" questions before and after the treatment. Skin prick test was applied to all children in the sample group by the same nurse, in accordance with the procedure steps.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • Children aged 3-6 years.
  • The child and his/her parents volunteer to participate in the research.
  • No mental or neurological disability,
  • Not having a life-threatening disease,
  • Children's cognitive level and motor development are appropriate,
  • No visual or auditory problems,
  • Children who have not undergone any invasive procedure other than skin prick testing.
  • Those who have not had a skin prick test before.
  • The child does not complain of acute pain. (Pain scale VAS score is 0)

排除标准

  • Children requiring intravenous or intramuscular intervention before skin prick test
  • Development of complications during the procedure
  • Being so agitated that it is impossible to communicate with the child.

结局指标

主要结局

WONG-BAKER FACES PAIN RATING SCALE

时间窗: day 1

In this scale, faces are given pain scores according to numerical values. The lowest score is "0" and the highest score is "10". As the score from the scale increases, the intensity of pain increases, and as the score decreases, the intensity decreases.

次要结局

  • Children's Fear Scale(day 1)

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Selime MERTER

ASSISTANT PROFESSOR

Firat University

研究点 (2)

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