The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Procedural Pain Score
研究概览
简要总结
Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications. This randomized controlled trial evaluates the impact of Gentle Human Touch (GHT) and rate change (eye mask and earplug) on pain and comfort during heel prick blood collection in premature infants (32-36+6 weeks gestational age). A total of 60 infants were randomly assigned to three groups: GHT, rate change, and standard care (pacifier). Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R), and comfort was measured before, during, and after the procedure using the COMFORTneo operator. Physiological impact (heart rate, oxygen saturation) and propagation time were recorded. The findings provide evidence for safe and effective non-pharmacological interventions in pain management and their inclusion in developmental care protocols.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 32 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants with a gestational age between 32 and 36+6 weeks
- •Written informed consent obtained from parents
排除标准
- •Infants with serious medical conditions that may affect study parameters
- •Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)
研究组 & 干预措施
Gentle Human Touch
Gentle human touch (GHT) will be applied 3-5 minutes before, during, and after the heel prick blood test.
干预措施: Gentle Human Touch (Other)
Environmental Modification
Eye mask and earmuffs will be applied 3-5 minutes before, during, and after the heel prick blood test.
干预措施: Environmental Modification (Other)
Standard Care
Finger feeding will be provided before, during, and after the procedure, according to the unit routine.
结局指标
主要结局
Procedural Pain Score
时间窗: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
The pain experienced during heel prick blood sampling will be assessed using the Premature Infant Pain Profile-Revised (PIPP-R) scale. The scale ranges from 0 to 21 (for premature infants), with higher scores indicating greater pain intensity.
Procedural Comfort Score
时间窗: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
Comfort during heel prick blood sampling will be assessed using the COMFORTneo Scale. The scale ranges from 7 to 35, with higher scores indicating a lower level of comfort.
次要结局
- Crying Duration(During and immediately after heel prick blood sampling)
- Oxygen Saturation(5 minutes before, during, and 5 minutes after heel prick blood sampling)
研究者
Kubra Nur Kabakcı Sarıdağ
Research Assistant Kubra Nur Kabakcı Sarıdağ
Baskent University