跳至主要内容
临床试验/NCT06611605
NCT06611605已完成不适用

Effect of Storytelling with Metaphor Toy Used During Venous Blood Collection on Fear and Anxiety Levels in Children: Randomized Controlled Trial

Akdeniz University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Fear level

研究概览

简要总结

The hospital environment is an unfamiliar environment for children, and unfamiliar people, unknown medical tools and equipment, sounds, and medical procedures in this environment can cause negative emotional states such as fear and anxiety in them. Venous blood collection is one of the most common invasive procedures applied to children who are hospitalized for routine health check-ups or for treatment and care. This procedure can be traumatic enough to create negative emotional states in children and affect them even in their later lives. This study was planned as a randomized controlled experimental study with pre-test-post-test measurements, including intervention (n= 34) and control (n= 34) groups, in order to reduce the fear and anxiety levels of children with the metaphor toy used during venous blood collection. The Child Identification Form, Children Fear Scale, and Children Emotional Manifestation Scale will be used as data collection tools in the study. 68 children between the ages of 7-10 who applied to Akdeniz University Hospital Pediatric Blood Collection Unit will constitute the universe of the research. Data will be collected by face-to-face interview method after receiving institutional permission for the conduct of the research and parental consent. After the final test data collection phase of the research is completed, the obtained data will be analyzed using Statistical Package of Social Science (SPSS) 23.0 software package program. The data evaluation process will be carried out with the support of a statistics expert. It is predicted that the metaphor toy used during the venous blood collection process and storytelling will have lower fear and anxiety levels in the intervention group children compared to the control group children.

详细描述

This study was planned as a randomized controlled experimental study with pre-test-post-test measurements including intervention (n= 34) and control (n= 34) groups in order to reduce fear and anxiety levels in childrens by using a metaphor toy during venous blood collection. The toy to be used in the study was developed by the researchers in order to metaphorize the blood collection process. In the study, the metaphor toy to be used during the blood collection process was used to narrate the bee collecting honey from a flower. In this way, the blood collection process, which can cause fear and anxiety in children, will be metaphorized. The Child Identification Form, Child Fear Scale and Children Emotional Manifestation Scale will be used as data collection tools in the study. 68 children between the ages of 7-10 who applied to Akdeniz University Hospital Pediatric Blood Collection Unit will constitute the universe of the study. Data will be collected by face-to-face interview method after receiving institutional permission for the conduct of the study and parental consent. After the final test data collection phase of the study is completed, the data obtained will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The data evaluation process will be carried out with the support of a statistics expert. It is anticipated that the storytelling with the metaphor toy used during the venous blood collection process will have lower fear and anxiety levels in the intervention group children compared to the control group children.

Intervention Group The research will be implemented in stages. Stage 1: Preliminary Implementation of the Research (First Measurement) A preliminary implementation was conducted with 5 children who met the inclusion criteria of the research in order to evaluate the comprehensibility and applicability of the surveys and storytelling with metaphor toys. After the preliminary implementation, the final version of the application was decided. During the preliminary implementation, a positive change was observed in the emotional states of the children who were applied the intervention after the storytelling with metaphor toys. The children included in the preliminary implementation will not be included in the research sample.

Stage 2: Application After randomization, the pre-test will be applied by the researcher to the children included in the intervention group after obtaining consent from their parents.

The pre-test will be applied to the child who meets the inclusion criteria for the study.

Before the children included in the intervention group proceed to the blood collection process, the story will be told to the child by the researcher in the waiting room of the Akdeniz University Hospital Blood Collection Unit through a metaphor toy. The child and the parent will be together during the story telling. The story presented below will be told to the child in the blood collection unit. Expert opinions were obtained from five academics who completed their doctoral education in the field of Child Health and Disease Nursing for the content of the story.

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
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A child between the ages of 7-10 who applied to the Blood Collection Department at Akdeniz University Hospital
  • A child whose blood has not been drawn in the last year
  • No vision or hearing problems
  • No mental or neurological disabilities
  • Able to speak and understand Turkish

排除标准

  • Wanting to leave the study
  • Not accepting the final test application

结局指标

主要结局

Fear level

时间窗: Change from Baseline (immediately before venous blood collection), immediately after blood collection

The level of fear will be evaluated among the outcome criteria. The level of fear will be measured with the Child Fear Scale (CFS). The lowest score for CFS is 0 and the highest score is 4. A low score on this scale, which is specific to children, indicates low fear.

Anxiety level

时间窗: Time Frame: Change from Baseline (immediately before venous blood collection), immediately after blood collection

The level of anxiety will be evaluated among the outcome criteria. The level of anxiety will be measured with the Children Emotional Manifestation Scale (CEMS). The lowest score for CEMS is 5 and the highest score is 25. A low score on this scale, which is specific to children, indicates low anxiety.

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

Ayla Kaya

Associate Professor, RN, Ph.D

Akdeniz University

研究点 (2)

Loading locations...

相似试验