Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Neonatal Infant Pain Scale
研究概览
简要总结
This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor responsible for evaluating pain and stress outcomes will be blinded to group allocation.
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Maternal Scent
The newborn will be exposed to maternal breast milk scent during the procedure.
干预措施: Maternal Scent (Other)
Maternal Voice
The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
干预措施: Maternal Voice (Other)
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.
干预措施: Maternal Touch (Other)
Control
Routine heel lance procedures will be performed, and no sensory intervention will be provided.
结局指标
主要结局
Neonatal Infant Pain Scale
时间窗: Before the procedure, during the procedure, and immediately after the procedure
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.
次要结局
- Newborn stress scale(Before the procedure, during the procedure, and immediately after the procedure)
研究者
Elif Simay KOÇ
Lecturer
Kilis 7 Aralik University