MOTHER3SENSE Study (MOTHER3SENSE)
Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions
研究概览
详细说明
Painful procedures are frequently performed in newborns during routine clinical care and may lead to physiological and behavioral stress responses. Non-pharmacological interventions are recommended as safe and effective approaches for reducing procedural pain and stress in newborns. Maternal sensory stimuli, including maternal voice, touch, and scent, may provide comfort and support neonatal regulation during painful procedures.
This randomized controlled trial aims to compare the effects of maternal voice, maternal touch, and maternal scent on pain and stress responses in newborns undergoing a routine heel lance procedure. Eligible newborns will be randomly assigned to one of four groups: maternal voice, maternal touch, maternal scent, or control.
The assigned intervention will be applied according to a standardized protocol before, during, and after the heel lance procedure. Pain and stress responses will be assessed at three time points: before the procedure, during the procedure, and after the procedure. Behavioral and physiological indicators will be used to evaluate neonatal pain and stress responses.
The primary objective of the study is to determine and compare the effectiveness of maternal voice, touch, and scent in reducing procedural pain and stress in newborns. The findings may contribute to evidence-based, family-centered, and non-pharmacological pain management practices in neonatal care.
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：Elif Simay KOÇ, Lecturer
- 电话号码：+90 348 813 93 01
- 邮箱：kocelifsimay@gmail.com
学习地点
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Kilis、土耳其（türkiye）、79000
- Kilis Alaeddin Yavaşça State Hospital
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接触：
- Elif Simay KOÇ
- 电话号码：+90 348 813 93 01
- 邮箱：kocelifsimay@gmail.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:
- Term newborns born between 37 and 42 weeks of gestation
- Newborns without respiratory, cardiac, metabolic, neurological, or infectious diseases
- Newborns not requiring oxygen therapy, phototherapy, or intravenous treatment
- Newborns scheduled to undergo a routine heel lance procedure (metabolic screening or blood sampling)
- Mothers willing to participate in the study
- Written informed consent provided by the parent or legal guardian
- Normal vital signs before the procedure (heart rate, respiratory rate, and oxygen saturation within normal limits)
Exclusion Criteria:
- Preterm (<37 weeks) or post-term (>42 weeks) newborns
- Presence of congenital anomalies or neurological disorders
- Requirement for oxygen therapy, phototherapy, or intravenous treatment
- Respiratory, cardiac, metabolic, neurological, or infectious disease
- Abnormal vital signs before the procedure
- Parent or legal guardian refusal to provide informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Maternal Voice
The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
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The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
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实验性的：Maternal Touch
The mother will maintain contact with the newborn's palms before, during, and after the procedure to stimulate the grasp reflex and provide tactile sensory input.
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The mother will maintain contact with the newborn's palms before, during, and after the procedure to stimulate the grasp reflex and provide tactile sensory input.
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实验性的：Maternal Scent
The newborn will be exposed to maternal breast milk scent during the procedure.
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The newborn will be exposed to maternal breast milk scent during the procedure.
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无干预：Control
Routine heel lance procedures will be performed, and no sensory intervention will be provided.
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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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Neonatal Infant Pain Scale
大体时间：Before the procedure, during the procedure, and immediately after the procedure
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The Neonatal Infant Pain Scale (NIPS), originally developed by Lawrence et al. (1993), was adapted into Turkish by Akdovan (Akdovan & Yıldırım, 1999).
NIPS is used to assess procedure-related pain in newborn infants.
The scale evaluates five behavioral indicators-facial expression, crying, arm movements, leg movements, and state of arousal-as well as one physiological parameter, breathing pattern.
Pain is assessed based on the evaluation of these behavioral and physiological responses.
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Before the procedure, during the procedure, and immediately after the procedure
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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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Newborn stress scale
大体时间：Before the procedure, during the procedure, and immediately after the procedure
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The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık, consists of 24 items rated on a 3-point Likert scale.
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Before the procedure, during the procedure, and immediately after the procedure
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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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Newborn and Maternal Characteristics Form
大体时间：At baseline
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This researcher-developed form, based on the literature, was used to systematically collect demographic information about mothers and medical and birth-related characteristics of newborns.
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At baseline
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Neonatal Physiological Parameters Monitoring Form
大体时间：Before the procedure, during the procedure, and immediately after the procedure
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The Newborn Physiological Parameters Assessment Form was developed by the researchers based on the literature and was used to evaluate physiological parameters, including heart rate, oxygen saturation, and body temperature, before, during, and after the heel lance procedure.
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Before the procedure, during the procedure, and immediately after the procedure
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
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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