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临床试验/NCT07044713
NCT07044713招募中不适用

A Comparison of the Use of Hand Puppets and Image Watching and Coloring Books for Children in Reducing Pain and Fear During Blood Collection Procedures

Artvin Coruh University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7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
招募中
发起方
入组人数
90
试验地点
2
主要终点
Patient Identification Form

研究概览

简要总结

The aim of this study was to compare a hand puppet with image viewing and a coloring book for children in reducing children's pain and fear during blood collection.

详细描述

Ninety volunteer children aged 3-6 coming for blood collection will be randomly divided into three groups: hand puppet, viewing and painting the image, and control group. Children will be assessed before, during, and after the procedure. Pain related to blood collection will be assessed with the Wong-Baker Faces Pain Scale, and fear will be assessed with the Child Fear Scale. In addition, children's demographic data will be recorded in 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
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Being between 3-6 years old
  • •Taking blood samples at once
  • •No visual-auditory and speech disorders
  • •Being open to communication and
  • •Being accompanied by a parent.

排除标准

  • •Having a chronic disease
  • •Having a visual-auditory and speech disorder
  • •History of sedative, analgesic or narcotic substance use within 24 hours before admission
  • •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

Before blood collection, the child will be shown games with hand puppets and will be asked to watch the image and color with the Coloring Book.

干预措施: Hand Puppet (Other)

Experimental Group

Experimental

Before blood collection, the child will be shown games with hand puppets and will be asked to watch the image and color with the Coloring Book.

干预措施: The Visual Viewing and Coloring Book (Other)

结局指标

主要结局

Patient Identification Form

时间窗: Baseline

It is a form consisting of 7 questions in total, including the child's age, gender, previous hospital experience, if any, how many times the child has been hospitalized, whether the parents have prepared for the blood collection process beforehand, experience of having blood drawn in the last six months, and reactions to the blood collection process. It was prepared by researchers in accordance with the literature.

Wong Baker Face Pain Scale

时间窗: Baseline and up to 4 weeks

Children between the ages of three and eight can express many pain areas and their severity. In this study, the Wong-Baker Pain Inventory will be used in combination with the Visual Analog Scale, since face scales are more appropriate. The Wong Baker Face Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". A score of "0" indicates no pain and a score of "10" indicates the highest pain. This scale does not have a Cronbach's alpha score. It has been reported that reliability studies have not been conducted on such scales. In our study, the child will be shown the facial expressions on the pain scale and asked which one it is, and the score co

Child Fear Scale

时间窗: Baseline and up to 4 weeks

The Turkish validity of this scale, developed by McMurtry and colleagues, was done by Gerçeker and colleagues. The changes in the facial muscles of the frightened expression were drawn by a graphic artist from a photograph of a frightened face. It can be used by the parent, child or researcher to scale the child's fear. The scale, which has facial expressions scored from 0 to 4, is shown to the child. A score of 4 indicates that the child is very frightened, and a score of 0 indicates that the child is not frightened. It is accepted that a score of "0" indicates a neutral expression (no fear), a score of "1" indicates a very low level of fear, a score of "2" indicates a little fear, a score of "3" indicates a greater level of fear, and a score of 4 indicates that the level of fear is at the highest level. This scale can be used to measure fear before and during the procedure. In our study, the child will be shown the facial expressions on the

Wong Baker Face Pain Scale

时间窗: Baseline and up to 4 weeks

Children between the ages of three and eight can express many pain areas and their severity. In this study, the Wong-Baker Pain Inventory will be used in combination with the Visual Analog Scale, since face scales are more appropriate. The Wong Baker Face Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". A score of "0" indicates no pain and a score of "10" indicates the highest pain. This scale does not have a Cronbach's alpha score. It has been reported that reliability studies have not been conducted on such scales. In our study, the child will be shown the facial expressions on the pain scale and asked which one it is, and the score co

Patient Identification Form

时间窗: Baseline

It is a form consisting of 7 questions in total, including the child's age, gender, previous hospital experience, if any, how many times the child has been hospitalized, whether the parents have prepared for the blood collection process beforehand, experience of having blood drawn in the last six months, and reactions to the blood collection process. It was prepared by researchers in accordance with the literature.

Child Fear Scale

时间窗: Baseline and up to 4 weeks

The Turkish validity of this scale, developed by McMurtry and colleagues, was done by Gerçeker and colleagues. The changes in the facial muscles of the frightened expression were drawn by a graphic artist from a photograph of a frightened face. It can be used by the parent, child or researcher to scale the child's fear. The scale, which has facial expressions scored from 0 to 4, is shown to the child. A score of 4 indicates that the child is very frightened, and a score of 0 indicates that the child is not frightened. It is accepted that a score of "0" indicates a neutral expression (no fear), a score of "1" indicates a very low level of fear, a score of "2" indicates a little fear, a score of "3" indicates a greater level of fear, and a score of 4 indicates that the level of fear is at the highest level. This scale can be used to measure fear before and during the procedure. In our study, the child will be shown the facial expressions on the

次要结局

未报告次要终点

研究者

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

Gamze Akay

Assistant Professor

Artvin Coruh University

研究点 (2)

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