Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns
The Effect of Multisensory Stimulation Applied During Heel Blood Sampling on Pain and Physiological Parameters in Newborns: A Randomized Controlled Trial
研究概览
详细说明
Heel blood sampling is a routine procedure used in newborn screening; however, it can produce pain, crying, and short-term changes in physiological parameters such as heart rate and oxygen saturation. Non-pharmacological approaches are commonly used to reduce procedural pain in newborns, but the effects of individual methods may be inconsistent. Multisensory stimulation combines several familiar and comforting sensory inputs and may reduce pain by directing attention away from the procedure, supporting autonomic regulation, and decreasing the stress response.
In this study, multisensory stimulation will consist of breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout the procedure. The control condition will reflect supportive routine care, with the newborn held in the mother's arms during heel blood sampling.
The study will examine whether this structured multisensory approach reduces procedural pain and crying and supports physiological stability in healthy newborns. Pain, heart rate, and oxygen saturation will be assessed before, during, and after heel blood sampling. Crying duration and total procedure duration will also be recorded. The findings may contribute to the development of a safe, practical, and standardized non-pharmacological approach to pain management during routine newborn procedures.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：İlçim Ercan-Koyuncu, PhD
- 电话号码：+905534700629
- 邮箱：ilcimercan@hotmail.com
学习地点
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Beşevler
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Ankara、Beşevler、土耳其（türkiye）、60300
- 招聘中
- Tatvan State Hospital
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接触：
- İlçim Ercan-Koyuncu
- 电话号码：05534700629
- 邮箱：ilcimercan@hotmail.com
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Bitlis
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Bitlis、Bitlis、土耳其（türkiye）、60300
- 招聘中
- Bitlis State Hospita
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接触：
- İlçim Ercan-Koyuncu
- 电话号码：05534700629
- 邮箱：ilcimercan@hotmail.com
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-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Healthy newborns aged 0-28 days
- Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit
- Written informed consent provided by the newborn's parent or legal representative
Exclusion Criteria:
- Presence of any lower-extremity anomaly
- Ongoing monitoring or treatment in the neonatal intensive care unit
- Presence of a congenital disease
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Multisensory Stimulation Group
Newborns assigned to this arm will receive a structured multisensory stimulation intervention during heel blood sampling.
The intervention will include breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn.
Breastfeeding and gentle stroking will begin 10 minutes before the procedure and continue until 5 minutes after the procedure.
Maternal singing and eye contact will be maintained throughout heel blood sampling.
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The multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact.
Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure.
During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained.
Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn.
No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication.
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无干预：Mother's Arms Control Group
Newborns assigned to this arm will receive routine heel blood sampling while being held in their mother's arms.
No additional structured non-pharmacological pain-reduction intervention will be administered.
When necessary, the mother may gently hold and support the newborn in a comfortable position during the procedure.
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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 |
|---|---|---|
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N-PASS Pain Score
大体时间：Immediately before, during, and immediately after heel blood sampling.
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Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS).
The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs.
Higher pain scores indicate greater pain or agitation.
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Immediately before, during, and immediately after heel blood sampling.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Crying Duration
大体时间：During the heel blood sampling session.
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The total duration of crying associated with heel blood sampling will be measured using a stopwatch and recorded in seconds.
A shorter crying duration indicates a more favorable outcome.
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During the heel blood sampling session.
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Heart Rate
大体时间：Immediately before, during, and immediately after heel blood sampling.
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Heart rate will be measured non-invasively using a bedside pulse oximeter and recorded as beats per minute.
Heart rate values will be assessed to determine physiological responses to heel blood sampling and the multisensory stimulation intervention.
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Immediately before, during, and immediately after heel blood sampling.
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Oxygen Saturation
大体时间：Immediately before, during, and immediately after heel blood sampling.
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Peripheral oxygen saturation will be measured non-invasively using a bedside pulse oximeter and recorded as a percentage.
Higher and more stable oxygen saturation values indicate a more favorable physiological response.
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Immediately before, during, and immediately after heel blood sampling.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Procedure Duration
大体时间：During a single heel blood sampling procedure
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The total duration of the heel blood sampling procedure will be measured using a stopwatch and recorded in seconds.
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During a single heel blood sampling procedure
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合作者和调查者
出版物和有用的链接
一般刊物
- Garcia-Valdivieso I, Yanez-Araque B, Moncunill-Martinez E, Bocos-Reglero MJ, Gomez-Cantarino S. Effect of Non-Pharmacological Methods in the Reduction of Neonatal Pain: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 12;20(4):3226. doi: 10.3390/ijerph20043226.
- Jin L, Zhang J, Yang X, Rong H. Maternal voice reduces procedural pain in neonates: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Mar 24;102(12):e33060. doi: 10.1097/MD.0000000000033060.
- Sahin K, Yildiz S, Gur E. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:20-30. doi: 10.1016/j.pedn.2025.11.051. Epub 2026 Jan 6.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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