The Effect of Pop-it Game and Stress Ball Usage on Pain and Anxiety Levels During Blood Collection in Children Aged 3-6 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Child-reported pain experienced during the blood collection procedure assessed using the Wong-Baker FACES Pain Rating Scale
研究概览
简要总结
Blood collection can cause pain and anxiety in children. This randomized controlled study investigated whether using a pop-it game or a stress ball during blood collection could reduce pain and anxiety in children aged 3-6 years. The study included 78 children who were assigned to a pop-it game group, a stress ball group, or a control group. Pain and anxiety levels were assessed during the blood collection procedure.
详细描述
Children were assessed according to the inclusion criteria and randomly assigned to the Pop-it, stress ball, or control groups. Children and parents were informed about the study, and informed consent was obtained.
Pain and anxiety were assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS) and the Children's Emotional Expression Assessment Scale (CEEAS).
Blood collection was performed by the same experienced nurse using a standardized procedure. The Pop-it group played with a Pop-it toy, while the stress ball group squeezed and released a stress ball with their free hand, starting 1 minute before blood collection and continuing throughout the procedure. The control group received routine phlebotomy without any non-pharmacological intervention.
Procedure duration and crying duration were recorded with stopwatches. Anxiety was assessed by both the researcher and the parent during the procedure. One minute after blood collection, pain and anxiety were reassessed using the WBFPRS and CEEAS.
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
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3 to 6 years.
- •Accompanied by a parent.
- •Absence of any auditory, mental, or neurological disability
- •Being communicative and open to interaction.
- •Not having received any analgesic, antipyretic, anti-inflammatory, sedative, or anxiolytic medication within the previous 6 hours.
- •Absence of acute pain prior to the procedure.
- •Phlebotomy performed by the same nurse.
- •No history of regular invasive procedures (i.e., no chronic disease requiring routine blood monitoring, such as cancer or diabetes).
- •Willingness of both the child and parent to participate in the study.
排除标准
- •inability to perform the phlebotomy procedure on the first attempt.
研究组 & 干预措施
Pop-it Game Group
Children in this group played with a pop-it toy during the blood collection procedure
干预措施: Pop-it Game (Behavioral)
Stress Ball Group
Children in this group squeezed and released a stress ball during the blood collection procedure
干预措施: Stress Ball (Behavioral)
Control Group
Children in this group underwent the routine blood collection procedure without the use of a pop-it game or stress ball.
结局指标
主要结局
Child-reported pain experienced during the blood collection procedure assessed using the Wong-Baker FACES Pain Rating Scale
时间窗: Immediately after completion of the blood collection procedure
Child-reported pain experienced during the blood collection procedure was assessed using the Wong-Baker FACES Pain Rating Scale immediately after completion of the blood collection procedure
Child-reported post-procedural pain assessed using the Wong-Baker FACES Pain Rating Scale
时间窗: 1 minute after completion of the blood collection procedure
Child-reported post-procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale 1 minute after completion of the blood collection procedure.
次要结局
- Anxiety assessed using the Children's Emotional Expression Assessment Scale by parents and researchers(1 minute before the blood collection procedure; immediately after the procedure for observations made during the procedure; and 1 minute after the procedure)
- Crying duration before, during and after the blood collection procedure(Perioperative/Periprocedural)
- Duration of the blood collection procedure(From initiation to completion of the blood collection procedure)
研究者
Bensu KENAR
Principal Investigator
Trakya University