The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns
2026年9月14日 更新者：Kubra Nur Kabakcı Sarıdağ
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.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kubra Nur N KABAKCI SARIDAĞ, RN, MSc
- 电话号码：+905079149033
- 邮箱：kubranurkabakci@gmail.com
学习地点
-
-
-
Ankara、土耳其（türkiye）
- 招聘中
- Etlik City Hospital
-
接触：
- Kübra S Kabakcı Sarıdağ
- 电话号码：+90 5079149033
- 邮箱：kubranurkabakci@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
描述
Inclusion Criteria:
- Preterm infants with a gestational age between 32 and 36+6 weeks
- Written informed consent obtained from parents
Exclusion Criteria:
- Infants with serious medical conditions that may affect study parameters
- Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Gentle Human Touch
Gentle human touch (GHT) will be applied 3-5 minutes before, during, and after the heel prick blood test.
|
Before starting the procedure, the nurse performing the intervention will wear a clean gown and wash both hands and forearms with an antimicrobial agent for 3 minutes. The nurse's hand temperature will be measured with a digital thermometer prior to the intervention to ensure it is at an appropriate level. If the temperature is not suitable, both hands will be warmed under a radiant warmer until they reach 33-33.2 °C, and the intervention will begin once this temperature is achieved. During the intervention, the nurse will place the fingertips of one hand on the infant's eyebrow line with the palm resting on the top of the head, while the other hand will be positioned on the lower abdomen covering the waist and hips, maintaining this position for 15 minutes. |
|
实验性的：Environmental Modification
Eye mask and earmuffs will be applied 3-5 minutes before, during, and after the heel prick blood test.
|
Infants assigned to the environmental modification group will receive an eye mask and neonatal earmuffs (Minimuffs) to reduce exposure to light and noise.
The eye mask is a soft, adjustable, and disposable phototherapy band designed to block external light stimuli.
The earmuffs are oval-shaped, foam-based neonatal ear protectors with hydrogel adhesive, designed to reduce noise levels by more than 50% and ensure safe single use.
Both interventions will be applied 3-5 minutes before, during, and for 3-5 minutes after venous blood sampling, for a total of approximately 15 minutes.
Standard care with a pacifier will also be provided according to unit practice.
|
|
无干预：Standard Care
Finger feeding will be provided before, during, and after the procedure, according to the unit routine.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedural Pain Score
大体时间：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.
|
5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
|
|
Procedural Comfort Score
大体时间：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.
|
5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Crying Duration
大体时间：During and immediately after heel prick blood sampling
|
Total duration of crying during heel prick blood sampling will be measured with a stopwatch and recorded in seconds.
|
During and immediately after heel prick blood sampling
|
|
Oxygen Saturation
大体时间：5 minutes before, during, and 5 minutes after heel prick blood sampling
|
Oxygen saturation levels will be monitored with pulse oximetry.
|
5 minutes before, during, and 5 minutes after heel prick blood sampling
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月20日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年2月19日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月20日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.