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临床试验/NCT06686992
NCT06686992已完成不适用

The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration: a Randomized Controlled Trial

Ataturk University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Wong-Baker Facial Expression Rating Scale (WB-FRAS)

研究概览

简要总结

The study will be conducted to examine the effect of distraction method on children's pain and fear levels during vaccine administration. The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.

详细描述

The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.

Round and Draw game: The game designed by the researcher will be used as the intervention tool in the study. The game is played by creating a face picture by drawing the corresponding sections with the help of a dice consisting of 6x5 sections. With the game, it is planned to minimize pain and fear in children during vaccination. Care will be taken to ensure that the materials to be used are appropriate for the developmental level of the children, easy to clean and do not develop any allergies in children.

Data Collection The researcher will be present in the centers where the study will be conducted for 1 day to examine the ergonomic structure of the pediatric family health centers before starting to collect the data of the play group and control group children. The children and their parents will be given preliminary information about the research (the purpose of the research, why the research is being conducted, the use of the roll-and-draw game in relieving the child's pain and fear, etc.), and after obtaining verbal consent from the children and written consent from the parents, the data of the research will be obtained by face-to-face interview method with the children who agree to participate in the research.

Control Group: The questionnaires and scales will be filled in by the researcher 5 minutes before the vaccination process. Only routine 4-year-old vaccines will be administered. The scales will be filled out again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.

Interventıon Group: The questionnaire and scales will be filled out by the researcher 5 minutes before vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.

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 (Participant)

入排标准

年龄范围
4 Years 至 4 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Being 4 years old
  • •Not having a disability related to developmental areas
  • •The mother or father should be with the child during the procedure

排除标准

  • •being older or younger than 4 years old
  • •having a chronic disease
  • •lack of willingness to work

研究组 & 干预措施

distraction

Experimental

The researcher will fill in the questionnaire and scales 5 minutes before the vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.

干预措施: Vaccination (Behavioral)

control

No Intervention

Questionnaires and scales will be filled out by the researcher 5 minutes before vaccination. Only routine applications will be made. The scales will be filled again 5 minutes after vaccination.

结局指标

主要结局

Wong-Baker Facial Expression Rating Scale (WB-FRAS)

时间窗: 1 months

This scale is used to diagnose pain in children aged 3-18 years. In this scale, there are six faces representing increasing pain intensity from zero to five from left to right. The leftmost face has a smiling expression, indicating a pain-free state, while the rightmost face has a crying expression, corresponding to the most severe pain. The child is instructed to choose the face that best expresses their own emotions. Six facial expressions are scored from left to right from 0 to 5 points (0 points= very happy/no pain, 5 points= most severe pain). As the score obtained from the scale increases, pain tolerance decreases and as the score decreases, tolerance increases.

Child Fear Scale

时间窗: 1 months

The Child Fear Scale was developed in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 scale with five faces ranging from neutral (0 = no concern at all) to fearful (4 = severe concern).

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

ARZU SARIALİOĞLU

Associate professor

Ataturk University

研究点 (1)

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