Effect of Therapeutic Play With Amigurumi Toys During Blood Collection on Children's Pain and Fear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Wong-Baker Facial Expression Evaluation Scale
研究概览
简要总结
This study was planned to determine the effect of therapeutic play with amigurumi toys on pain and fear during blood collection in children aged 4 to 6 years who applied to the pediatric emergency department. The project is a randomized controlled trial. The study covers children aged 4-6 years who came to the blood collection unit of the pediatric emergency department of Recep Tayyip Erdoğan University Education and Research Hospital between January and June 2025. The research sample will consist of children who applied to the unit on the specified dates, met the research criteria, and volunteered to participate in the study. The "Survey Form", "Wong-Baker Facial Expression Assessment Scale" and "Child Fear Scale" will be used to collect data.
详细描述
Type of Study: The study is a randomized controlled trial. Population and Sample of the Research: The population of the research includes children aged 4-6 years who came to the pediatric blood collection unit of Recep Tayyip Erdogan University Training and Research Hospital pediatric emergency between January-June 2025.
The research sample; will consist of children who apply to the blood collection unit on the specified dates, meet the research criteria, and volunteer to participate in the study. The sample size of the study was calculated using the G*Power 3.1. 9.7 program. The results of the study titled "The Effect of Therapeutic Play Applied with Hand Puppets on Fear and Pain Due to Blood Collection in Preschool Children" by Oluç and Sarıalioğlu were used to determine the effect size of the study. In the calculation, the effect size was calculated as 0.71 (f = 0.71), 5% margin of error (α = 0.05) and 95% power (1-β = 0.95), and the sample size for each group was calculated as 40, and the study will be planned to be conducted with 80 children. It was decided to collect data from a total of 96 children (48 intervention, 48 control) by including a 20% spare sample in case of data loss.
In the study, "stratification and block randomization methods" will be used in assigning participants to control and intervention groups. It has been reported in the literature that variables such as age, gender and fear of interventional procedures are among the factors affecting the fear and anxiety experienced by children during interventional procedures. In this study, the variables of "age, gender and fear of blood collection" will be used in stratifying the children. Accordingly, the children will be stratified according to "age (4-5 and 6 years), gender (girls and boys) and fear of blood collection (fearful and not afraid)" and block randomization will be applied. In the study, 48 children will be included in each group by ensuring that the stratifications are repeated six times (2X3X2X4). The closed envelope method will be used to assign the stratified children to the control and intervention groups without bias. In the study, the data of each group will be collected on certain days of the week in order to prevent the child in one group from being affected by the procedure applied to the other group. The order of data collection of the groups will again be determined by the closed envelope method. The order of data collection for the control and intervention groups according to the days of the week will be as follows:
Toy group = Monday, Wednesday Control group = Tuesday, Thursday Data Collection Tools to be Used in the Research: Survey Form, Wong-Baker Facial Expression Assessment Scale and Child Fear Scale will be used to collect research data. Amigurumi toy will be used as an intervention tool in the research.
Survey Form: This form, prepared by the researcher by reviewing the literature, will include questions that include descriptive characteristics of the child.
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
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-6,
- •Those who applied to the hospital as outpatients due to an acute illness,
- •Those who were rated as yellow triage in the 3-level (red-yellow-green) triage system,
- •Those whose mother or father was with the child during the procedure,
- •Those whose blood was drawn with a single procedure,
- •Those whose health status was stable will be included in the study.
排除标准
- •- Children who have a history of sedative, analgesic or narcotic substance use within 24 hours before application,
- •Children with a fever higher than 38 °C,
- •Children with visual, hearing, language development, mental and neurological disorders,
- •Children with a chronic or life-threatening disease,
- •Children who refuse to participate in the study,
- •Children who are treated in the red or green zone according to the triage system (red = critical emergency, requiring immediate action; yellow = unstable condition, requiring intervention within 60 minutes; and green = stable condition, intervention should be performed within 2 hours) will not be included in the study.
结局指标
主要结局
Wong-Baker Facial Expression Evaluation Scale
时间窗: 6 months
The scale was developed in 1981 and was revised in 1983. The scale is used to define pain in the 3-18 age group. The scale indicates that the severity of pain increases from zero to five as you go from left to right. Facial expressions are included under the numbers to describe the severity of pain. It consists of 6 faces in total. While the first smiling facial expression expresses the pain-free state, the crying facial expression at the end indicates the most severe pain intensity. While applying the scale, the child is told to choose the facial expression that best describes his feelings at the moment. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Child Fear Scale
时间窗: 6 months
The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).
次要结局
未报告次要终点
研究者
Gamzegül ALTAY
Principal Investigator
Recep Tayyip Erdogan University