The Effect of Distraction During Blood Collection on the Fear and Anxiety Levels of Children Aged Four to Six Years: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Child Fear Scale
研究概览
简要总结
The project is a randomized controlled trial. The population of the research will consist of children aged 4-6 years old who applied to Erzincan Mengücek Gazi Training and Research Hospital Pediatric Blood Collection Unit between June 2024 and June 2025. The sample of the research will consist of children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research. "Survey Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used to collect data.
详细描述
Type of Research: The research is of randomized controlled experimental type. Place and Time of the Research: The research will be carried out between June 2024 and June 2025 at the Pediatric Blood Collection Unit of Erzincan Mengücek Gazi Training and Research Hospital.
Population and Sample of the Research: The population of the research will consist of children between the ages of 4-6 who applied to Erzincan Mengücek Gazi Training and Research Hospital Pediatric Blood Collection Unit between June 2024 and June 2025. Research sample; It will consist of children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research. Prior power analysis was performed to determine the sample size in this study. Cohen's standard effect sizes were used as reference in the power analysis. In this case, for the t-test in independent groups in the study, it was determined that 90% power could be achieved with a 95% confidence interval at a significance level of 0.05 if the research was conducted with a total of 84 participants in two groups with 42 participants in each group. It was decided to collect data from a total of 90 children by including a 10% backup sample in this number in case of data loss.
Data Collection Tools to be Used in the Research: "Survey Form", "Child Fear Scale" and "Child Anxiety Scale - Statefulness" will be used in collecting research data. The liquid motion timed fountain toy will be used as an interference tool.
Intervention Tool to be Used in the Research Liquid Motion Timed Fountain Toy: A liquid motion timed fountain toy will be used as an intervention tool in the research. Guided by the cute bunny beanbag inside, there is a fascinating sight of falling balls. It is quite enjoyable to watch. It is also made of a special material against breakage. In this way, it does not pose any risk to children. Contains non-toxic materials. It is safe for children.
Before starting to collect the data of the intervention group and control group children, the researcher will be in the pediatric blood collection unit for 1 day to examine the pediatric blood collection unit and conduct a preliminary application. Children and their parents were given preliminary information about the research (the purpose of the research, why the research was conducted, a liquid moving timed fountain toy will be used to relieve the child's fear and anxiety, it is thought to be effective in preventing fear and anxiety, etc.) and their written and verbal consent was obtained. will be obtained through face-to-face meeting.
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
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being between 4-6 years old
- •Taking blood with a single attempt
- •Being admitted to the hospital for an acute reason
- •Children accompanied by their mother or father during the procedure
排除标准
- •Not having any disabilities related to developmental areas
- •No history of sedative, analgesic or narcotic substance use within 24 hours before application
- •Not having a chronic disease
研究组 & 干预措施
distraction
Questionnaires and scales will be filled out by the researcher 5 minutes before blood collection. Only routine applications will be made. The scales will be filled again 5 minutes after blood collection.
干预措施: distraction (Behavioral)
control
Questionnaires and scales will be filled out by the researcher 5 minutes before blood collection. The child will be allowed to play with the liquid moving, timed fountain toy 3 minutes before blood collection. During the process, the child will continue to play with the toy. The scales will be filled again 5 minutes after blood collection.
结局指标
主要结局
Child Fear Scale
时间窗: 6 months
The scale was developed to measure fear in children undergoing painful medical procedures. The scale is a 0-4 scale showing five faces ranging from a neutral expression (0 = no concern) to a fearful face (4 = severe concern).
Child Anxiety Scale - State
时间窗: 6 months
The Children's Anxiety Scale State (CAS-D) scale, which resembles a thermometer with horizontal lines, is scored as 0-10. It is a scale developed for children aged 4-10. When introducing the scale to the child, it is said that there is no anxiety, that the anxiety increases as it goes up, and that the anxiety level is very high at the top. The child is then asked to put a line on the part that shows how anxious or angry he or she is.
次要结局
未报告次要终点
研究者
ARZU SARIALİOĞLU
Principal Investigator
Ataturk University