Effects of ShotBlocker and Warm Gel Pack During Heel Prick Testing on Pain, Comfort, and Physiological Parameters in Healthy Term Newborns: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Neonatal Infant Pain Scale (NIPS) Score
研究概览
简要总结
This study evaluated the effects of ShotBlocker and a warm gel pack on pain, comfort, and physiological parameters during heel prick testing in healthy term newborns. A three-arm randomized controlled trial was conducted at a city hospital between October 2025 and May 2026. Newborns were randomly assigned to the ShotBlocker group, warm gel pack group, or routine care group. Pain was assessed using the Neonatal Infant Pain Scale (NIPS), and comfort was assessed using the Neonatal Comfort Behavior Scale (NCBS). Heart rate, respiratory rate, oxygen saturation, and heel temperature were also measured before and after the procedure. The study aimed to compare the effectiveness of these non-pharmacological interventions during routine heel prick testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open-label study. Due to the nature of the interventions (ShotBlocker and warm gel pack), blinding of participants and care providers was not possible. Statistical analyses were performed using blinded group codes to minimize analysis bias.
入排标准
- 年龄范围
- 0 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age ≥38 weeks
- •Healthy newborn
- •Scheduled for routine heel prick testing as part of the newborn screening program
- •1-minute APGAR score ≥7
- •No acute illness causing pain
- •No invasive procedures other than Hepatitis B vaccination after birth
排除标准
- •Mother does not speak Turkish
- •Parent unwilling to participate
- •Multiple pregnancy
- •Maternal or fetal complications during delivery
- •Known or suspected genetic or metabolic disorder in the mother or infant
研究组 & 干预措施
ShotBlocker
Participants received the ShotBlocker device during routine heel prick testing. The device was placed at the heel puncture site immediately before the procedure.
干预措施: ShotBlocker (Device)
Warm Gel Pack
Participants received a warm gel pack before routine heel prick testing. The gel pack was applied to the heel until the target temperature of 38-40°C was reached before blood sampling.
干预措施: Warm Gel Pack (Device)
Routine Care
Participants received routine heel prick testing without ShotBlocker or warm gel pack application.
结局指标
主要结局
Neonatal Infant Pain Scale (NIPS) Score
时间窗: Immediately after heel prick testing
Pain intensity will be assessed immediately after heel prick using the Neonatal Infant Pain Scale (NIPS). The NIPS is a behavioral pain assessment tool consisting of six indicators (facial expression, crying, breathing pattern, arm movements, leg movements, and state of arousal). Total scores range from 0 to 7, with higher scores indicating greater pain intensity. Scores \>3 indicate clinically significant pain.
次要结局
- Heart Rate(Before and immediately after heel prick testing)
- Respiratory Rate(Before and immediately after heel prick testing)
- Oxygen Saturation(Before and immediately after heel prick testing)
- Heel Temperature(Before and immediately after heel prick testing)
- Neonatal Comfort Behavior Scale (NCBS) Score(Before and immediately after heel prick testing)
研究者
Ayşegül Şimşek
Associate Professor
Marmara University