The Effect of Buzzy® and a Cognitive Behavioral Intervention Package on Pain and Fear During Blood Draw in Children: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Children's Anxiety Scale Score
研究概览
简要总结
This study evaluated the effects of Buzzy® and a Cognitive Behavioral Intervention Package on pain and fear/anxiety during blood draw in children aged 7-12 years. Blood draw is a common procedure in children, but it may cause pain, fear, and anxiety. Non-pharmacological methods may help children cope better with this procedure.
Children were randomly assigned to one of three groups: a control group, a Cognitive Behavioral Intervention Package group, or a Buzzy® group. Children in the control group received routine blood draw care. Children in the Cognitive Behavioral Intervention Package group received preparation, age-appropriate information, distraction, supportive guidance, parent support, and positive reinforcement. Children in the Buzzy® group received cold and vibration application before and during the blood draw procedure.
Pain and fear/anxiety levels were assessed by child self-report before and immediately after the blood draw. The study aimed to determine whether Buzzy® and the Cognitive Behavioral Intervention Package reduce pain and fear/anxiety compared with routine care.
详细描述
Needle-related procedures are among the most common sources of procedural pain, fear, and anxiety in children. Blood draw is a short but stressful procedure, and children may experience distress due to needle fear, previous negative experiences, uncertainty about the procedure, and limited coping skills. Poorly managed procedural pain and fear may negatively affect children's future responses to medical procedures.
This study focuses on two non-pharmacological approaches that may support children during blood draw. Buzzy® combines cold and vibration and is intended to reduce pain perception through sensory stimulation. The Cognitive Behavioral Intervention Package includes preparation, age-appropriate information, distraction, supportive communication, parent involvement, and positive reinforcement to help the child cope with the procedure.
The study was designed as a three-arm randomized controlled trial conducted in a pediatric blood drawing unit. The intervention procedures were applied within the routine clinical workflow of the unit. Pain and fear/anxiety were evaluated using child self-report measures before and immediately after the blood draw. By comparing Buzzy®, the Cognitive Behavioral Intervention Package, and routine care, this study aims to provide evidence for practical, child-friendly, and non-pharmacological strategies that can be used by healthcare professionals during pediatric blood draw procedures.
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 (Participant, Outcomes Assessor)
盲法说明
Due to the visible nature of the Buzzy® device and the interactive components of the Cognitive Behavioral Intervention Package, participants and intervention providers could not be blinded. Outcomes were assessed through child self-report; therefore, no independent blinded outcome assessor was used.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7 to 12 years
- •Able to read and write
- •No chronic disease
- •No visual, hearing, verbal communication, cognitive, or neurological impairment
- •No use of sedative, analgesic, or narcotic medication within 24 hours before the procedure
- •Willingness of both the child and parent to participate in the study
排除标准
- •Child's refusal to participate or continue the assessment process
- •Parent's request to withdraw from the study
- •Inability to complete the blood draw procedure in a single attempt
- •Missing essential data required for analysis
研究组 & 干预措施
Buzzy® Group
Children in this group received Buzzy® in addition to routine blood draw care. Buzzy® is a non-pharmacological device that combines cold and vibration. The device was applied 60 seconds before the blood draw and was continued during the procedure. During venipuncture, Buzzy® was placed approximately 3 cm proximal to the blood draw site.
干预措施: Buzzy® (Device)
Cognitive Behavioral Intervention Package Group
Children in this group received the Cognitive Behavioral Intervention Package in addition to routine blood draw care. The package included age-appropriate preparation and information about the blood draw procedure, pre-procedural distraction, supportive suggestions, parent guidance, distraction during the procedure, and positive reinforcement after the procedure. During the procedure, the child used a selected distraction technique, such as counting, singing, reciting a short poem, or answering questions, with researcher support.
干预措施: Cognitive Behavioral Intervention Package (Behavioral)
Control Group
Children in this group received routine blood draw care according to the standard procedure of the pediatric blood drawing unit. No additional non-pharmacological intervention, such as Buzzy® or the Cognitive Behavioral Intervention Package, was applied.
结局指标
主要结局
Children's Anxiety Scale Score
时间窗: Anxiety was assessed using the Children's Anxiety Scale. Higher scores indicate greater anxiety. Anxiety scores were evaluated by child self-report immediately before and immediately after the blood draw procedure.
Immediately before and immediately after the blood draw procedure
Children's Fear Scale Score
时间窗: Immediately before and immediately after the blood draw procedure
Fear was assessed using the Children's Fear Scale, a single-item child self-report measure consisting of five faces scored from 0 (no fear) to 4 (extreme fear). The total score ranges from 0 to 4, with higher scores indicating greater fear and therefore a worse outcome. Children reported their fear immediately before and immediately after the blood draw procedure.
Children's Anxiety Scale Score
时间窗: Immediately before and immediately after the blood draw procedure
Anxiety was assessed using the Children's Anxiety Scale-State, a single-item child self-report measure presented in a thermometer-like format and scored from 0 (no anxiety) to 10 (highest possible anxiety). The total score ranges from 0 to 10, with higher scores indicating greater state anxiety and therefore a worse outcome. Children reported their anxiety immediately before and immediately after the blood draw procedure.
Wong-Baker FACES Pain Rating Scale Score
时间窗: Immediately before and immediately after the blood draw procedure
Pain intensity was assessed using the Wong-Baker FACES® Pain Rating Scale, a single-item child self-report measure consisting of six faces. In this study, the faces were scored from 0 (no pain) to 5 (the most severe pain). The total score ranges from 0 to 5, with higher scores indicating greater pain intensity and therefore a worse outcome. Children reported their pain immediately before and immediately after the blood draw procedure.
次要结局
未报告次要终点
研究者
Birgul Erdogan
Principal Investigator, Assistant Professor, PhD, RN
Kocaeli University