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临床试验/NCT06856395
NCT06856395尚未招募不适用

Effect of Using Educational Robots During Vaccination on Fear and Pain in Children

Balikesir University0 个研究点目标入组 74 人开始时间: 2025年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
主要终点
Pain status of participants in the experimental group post vaccination

研究概览

简要总结

Pain and fear are very common in children during vaccination. We are planning to conduct a study to help children go through this process more comfortably. The aim is to examine whether the educational robot has an effect on pain and fear during vaccination in 4-year-old children in a randomized controlled manner.

详细描述

Data Collection Method:

A sample group of 74 people will be divided into two groups using www.randomizer.org using a simple randomization method.

Intervention group: The child patients in this group will be given the opportunity to get to know, touch and examine the educational mini robot for 5 minutes before the DaBT-IPA vaccination. The robot will attract the child's attention. During this time, the sociodemographic data form will be filled. At the end of the 5th minute, the child patient will prepare the vaccination with the cooperation of the staff and parents. During this time, the researcher will maintain the child's relationship with the robot and ensure that he/she focuses his/her attention on the robot. The application will end after the DaBT-IPA vaccination process. 5 minutes after the procedure, the Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. The robot will be cleaned with antiseptic solution after each child patient. Control Group: After the procedure is explained according to the child's developmental level, the DaBT-İPA vaccine will be administered in accordance with the institution's policies. 5 minutes later, the Sociodemographic data form, Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. At the end of the data collection, the control group will be provided with the opportunity to spend time with the robot in order to be beneficial.

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
Single (Outcomes Assessor)

入排标准

年龄范围
48 Months 至 60 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Volunteering to participate in the study
  • •The child must be 4 years old
  • •Must have come to a primary care center in Balıkesir city center
  • •DaBT-İPA vaccination must be administered
  • •Vastus Lateralis muscle must be used in vaccination

排除标准

  • •xclusion Criteria:
  • •Not volunteering to participate in the study
  • •The child is not 4 years old
  • •He/she has not come to a family health center in Balıkesir city center
  • •DaBT-İPA vaccination is not applied
  • •Vastus Lateralis muscle will not be used in vaccination application

研究组 & 干预措施

intervention group

Experimental

The child patients in this group will be given the opportunity to get to know, touch and examine the educational mini robot for 5 minutes before the DaBT-İPA vaccination. The robot will attract the child's attention. During this time, the sociodemographic data form will be filled. At the end of the 5th minute, the child patient will be prepared for the vaccination with the cooperation of the staff and parents. During this time, the researcher will maintain the child's relationship with the robot and ensure that he/she focuses his/her attention on the robot. The application will end after the DaBT-İPA vaccination procedure. 5 minutes after the procedure, the Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using the face-to-face interview technique. The robot will be cleaned with antiseptic solution after each child patient.

干预措施: intervention group (Other)

control group

No Intervention

After the procedure is explained according to the child's developmental level, the DaBT-IPA vaccine will be administered in accordance with the institution's policies. After 5 minutes, the Sociodemographic data form, Child Fear Scale (CHS), Wong Baker Pain Scale will be filled out by the researcher using the face-to-face interview technique. At the end of the data collection, the control group will be provided with time to spend with the robot in order to be beneficial.

结局指标

主要结局

Pain status of participants in the experimental group post vaccination

时间窗: 6 months

Average pain scale score of participants in the experimental group after vaccination. In the Wong Baker pain scale, the lowest value is expressed as 0 and the highest value is expressed as 5.

Pain status of participants in the control group post vaccination

时间窗: 6 months

Average pain scale score of participants in the control group after vaccination. In the Wong Baker pain scale, the lowest value is expressed as 0 and the highest value is expressed as 5.

次要结局

  • Fear status of participants in the experimental group post vaccination(6 months)
  • Children fear status of participants in the control group post vaccination(6 months)

研究者

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

Sibel Ergün

professor

Balikesir University

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