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临床试验/NCT05827783
NCT05827783已完成不适用

The Effect of Buzzy and Puppet on Pain and Fear During Phlebotomy in Children: A Randomized Controlled Study

Ege University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2022年7月8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
105
试验地点
1
主要终点
Statistical difference between groups about pain scores

研究概览

简要总结

Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy.

Method: This study is a randomized controlled trial. The study was conducted with 105 children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital. The sample of children (n=105) was divided into groups (group 1, Bee Buzzy; group 2, puppet; group 3, control) by block randomization. Children's pain and fear scores were evaluated using the Wong-Baker Pain Scale and Child Fear Scale, as well as the investigator's report, after phlebotomy, their parents, and the nurse who attempted phlebotomy.

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 (Investigator)

入排标准

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

入选标准

  • •Participants whose child and parents agreed to participate in the study
  • •Children who had successful phlebotomy on the first attempt

排除标准

  • •Children with chronic disease, mental disability, or mental retardation
  • •Children who had taken analgesics in the last 24 hours
  • •Children who were hospitalized
  • •Children who had undergone a surgical procedure
  • •Children who did not have successful phlebotomy on the first attempt

研究组 & 干预措施

Bee Buzzy

Experimental

Bee Buzzy Group: Bee Buzzy was attached to the 3-6-year-old child included in this group by the researcher on the arm of the nurse to perform the phlebotomy procedure. Bee Buzzy reduces pain thanks to its cold wings and vibration. It helps to distract attention during phlebotomy and reduces the feeling of pain and fear. Bee Buzzy was tied 5 cm above the area from which blood will be drawn, and after waiting for 15 seconds, the nurse performed a phlebotomy.

干预措施: Implementation of Bee Buzzy (Procedure)

Puppet Zuzu

Experimental

While the nurse was going to perform the phlebotomy operation on the 3-6-year-old child included in this group, one of the researchers (no. 2) tried to distract the child by putting the puppet on her hand and making her talk. The puppet used is an easy-to-use and hand-held puppet that will not cause fear in children. The puppet was named 'Zuzu' by researchers.

干预措施: Implementation of Puppet Zuzu (Procedure)

Control

No Intervention

No attempt was made to the 3-6-year-old child included in this group, during the process when the nurse performed the phlebotomy. Routine phlebotomy was performed. Pain and fear of the child during the procedure were evaluated.

结局指标

主要结局

Statistical difference between groups about pain scores

时间窗: During the procedure, approximately 5-10 minutes

Implementation of interventions aimed at reducing pain in experimental groups. Wong-Baker Facial Pain Rating Scale: The Facial Expression Rating Scale is a scale that includes 6 facial expressions and provides a rating between 0-10. This scale, which does not require words, is a reliable and valid measurement tool in the assessment of acute pain. A score of 0 indicates no pain and a score of 10 indicates the highest level of pain. In the scale, it means that as the pain score increases, the pain also increases.

Statistical difference between groups about fear scores

时间窗: During the procedure, approximately 5-10 minutes

Implementation of interventions aimed at reducing fear in experimental groups. Children's Fear Scale: This scale includes 5 different facial expressions. This scale is scored between 0-4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear. This scale does not require words. A score of 0 indicates no fear and a score of 4 indicates the highest level of fear. In the scale, it means that as the fear score increases, the fear also increases.

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

Şeyda BİNAY YAZ

Assistant professor

Ege University

研究点 (1)

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