Effect of Earmuffs on Physiological Stability, Sleep-Wake States, and Weight Gain in Preterm Neonates
Effect of Earmuffs on Physiological Stability, Sleep-Wake States, and Weight Gain in Preterm Neonates: A Randomized Controlled Trial
This study aims to evaluate the effect of earmuffs on physiological stability, sleep-wake states, and weight gain in preterm neonates admitted to neonatal intensive care units (NICUs). The study will compare preterm neonates receiving earmuffs in addition to routine nursing care with those receiving routine nursing care alone. Physiological stability will be assessed by measuring heart rate, respiratory rate, oxygen saturation, and body temperature. Sleep-wake states will be assessed using the Anderson Behavioral State Scoring (ABSS) system, and weight gain will be evaluated through body-weight measurements. The study may provide evidence on the potential role of earmuffs as a supportive nursing intervention for preterm neonates.
研究概览
详细说明
Preterm neonates admitted to neonatal intensive care units (NICUs) may be exposed to environmental noise generated by monitoring devices, alarms, respiratory support equipment, and routine staff activities. Because preterm neonates have immature physiological and neurological systems, protecting their developmental environment is an important aspect of neonatal supportive care.
Earmuffs may help reduce neonates' exposure to environmental noise. However, their effects on physiological stability, sleep-wake states, and weight gain need further evaluation. This study will investigate these outcomes to contribute evidence on the potential role of earmuffs in supportive nursing care for preterm neonates.
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：Marwa Y Alwan
- 电话号码：+9647810597443
- 邮箱：marwa.yasir2504m@conursing.uobaghdad.edu.iq
学习地点
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Nasiriyah、伊拉克
- Al-Haboubi Teaching Hospital
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接触：
- Marwa Alwan, MSc Student
- 电话号码：+9647810597443
- 邮箱：marwa.yasir2504m@conursing.uobaghdad.edu.iq
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Preterm neonates born at 28-36 completed weeks of gestation. 2. Neonates admitted to the NICU and requiring incubator care. 3. Clinically stable preterm neonates.
Exclusion Criteria:
- Neonates requiring mechanical ventilation. 2. Neonates with congenital anomalies 3. Neonates with neurological or brain disorders 4. Neonates with severe sepsis
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：Earmuff Intervention Group
Preterm neonates receive earmuffs in addition to routine nursing care. |
External neonatal earmuffs will be used as a non-pharmacological intervention to reduce preterm neonates' exposure to environmental noise in the neonatal intensive care unit. The earmuffs will be applied according to the manufacturer's instructions and the study protocol. The intervention group will receive earmuffs in addition to routine neonatal care. |
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无干预：Control Group
Preterm neonates receive routine nursing care alone, without the earmuff intervention. |
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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Sleep-Wake States in Preterm Neonates
大体时间：Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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(ABSS) system.Sleep-wake states will be assessed using the Anderson Behavioral State Scale (ABSS). The scale ranges from 1 to 12. Scores from 1-4 indicate sleep states, 5-7 indicate awake states, and 8-12 indicate restless states. Higher scores indicate a worse outcome (more restless/fussy), while lower scores indicate a better outcome (deep sleep). |
Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Heart Rate in Preterm Neonates
大体时间：Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Heart rate will be measured in beats per minute (bpm) using a pulse oximeter. |
Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Respiratory Rate in Preterm Neonates
大体时间：intervention.Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Respiratory rate will be measured by direct observation for one minute (counting breaths per minute). |
intervention.Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Oxygen Saturation (SpO2) in Preterm Neonates
大体时间：Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Oxygen saturation will be measured as a percentage (%) using a pulse oximeter. |
Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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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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Weight Gain in Preterm Neonates
大体时间：Baseline (Day 1), Day 5 (end of intervention), and Day 10 (follow-up).
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Body weight will be measured in grams using a calibrated neonatal weighing scale, and weight change will be assessed. |
Baseline (Day 1), Day 5 (end of intervention), and Day 10 (follow-up).
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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
与本研究相关的术语
其他研究编号
- UOB-EARMUFFS-2026
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