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临床试验/NCT07535151
NCT07535151尚未招募不适用

The Effect of Magic Mirror Use on Child's Pain and Mother's Anxiety During Vaccine Administration in Children: Randomized Controlled Study

Aydin Adnan Menderes University0 个研究点目标入组 126 人开始时间: 2026年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
126
主要终点
Information Sheet

研究概览

简要总结

Vaccination is one of the most common invasive procedures performed on healthy infants and children. These procedures can cause pain and fear in children and anxiety in parents. This study will be conducted to determine the effect of using animal-shaped magic mirrors during vaccination on pain in children aged 1-4 years and anxiety in mothers.

详细描述

The study is a randomized controlled experimental trial. Research data will be collected between February 1 and August 30, 2026. The study population will consist of children aged 1-4 years and their mothers who visit the Pediatrics Outpatient Clinic at Ankara Özel Koru Hospital. The sample will include 126 children and their mothers (Intervention group n=63; Control group n=63) who apply to the Ankara Koru Hospital Pediatric Outpatient Clinic for vaccination and meet the inclusion criteria. Children in the intervention group will be shown a magic mirror with animal figures at the moment of needle insertion during vaccination, while children in the control group will receive routine care without any intervention by the researchers. Data will be collected using the Informed Consent Form, the Eastern Ontario Children's Hospital Pain Scale, and the State Anxiety Inventory.

Descriptive statistics, Student's t-test or Mann Whitney U test for independent two-group comparisons, and t-test or Wilcoxon signed-rank test for dependent groups will be used in the analysis of the study. Statistical significance will be set at p<0.05.

Expected Results: The findings from this study are expected to contribute to the development of new non-pharmacological methods to reduce pain experienced by children during vaccination and to reduce negative emotions such as anxiety associated with the procedure in parents.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
Female
接受健康志愿者

入选标准

  • Mothers who have completed at least primary school and have no hearing, visual or intellectual disabilities.

排除标准

  • Children or their mothers who do not wish to participate during the vaccination process,
  • Children or their mothers who wish to withdraw from the study during the research process,
  • Those who provide incomplete answers to the study questions will be excluded from the study.

研究组 & 干预措施

1

group shown in the magic mirror

2

group not shown in the magic mirror

结局指标

主要结局

Information Sheet

时间窗: through study completion, an average of 3 mounth

This form contains the socio-demographic characteristics of the mother and child. In addition to basic information such as the child's age and gender, and the mother's age, educational level, employment status and the family's income level, the form also includes details regarding the presence of chronic illnesses in the child and mother, as well as information on the child's vaccination history.The information form consists of a total of 12 questions.

次要结局

未报告次要终点

研究者

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

Neslihan

Neslihan Durna

Aydin Adnan Menderes University

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