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Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns (NESTING)

2026年8月2日 更新者:Emine Nur Çalımlı Celep、Istanbul University - Cerrahpasa

The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section

This randomized controlled trial aims to evaluate the effect of nesting during the first intramuscular injection on pain, stress level, physiological parameters, settling time, and breastfeeding success in healthy term newborns delivered by cesarean section. A total of 112 newborns will be randomly assigned in a 1:1 ratio to either a nesting intervention group or a routine care control group. Newborns in the intervention group will receive nesting until the first intramuscular injection, whereas those in the control group will receive routine neonatal care. Pain, stress level, physiological parameters, settling time, and breastfeeding success will be evaluated using validated assessment tools. The findings are expected to provide evidence regarding the effectiveness of nesting as a simple, safe, and non-pharmacological intervention for reducing procedural pain and stress in newborns while supporting breastfeeding success.

研究概览

详细说明

Painful procedures performed during the first hours after birth, particularly intramuscular vitamin K and hepatitis B injections, are associated with significant pain and stress responses in newborns. Although several non-pharmacological interventions have been recommended to minimize procedural pain, evidence regarding the effectiveness of nesting in healthy term newborns delivered by cesarean section remains limited.

This study is designed as a prospective, single-center, parallel-group, randomized controlled trial. The study will be conducted in the newborn observation room of the Delivery Unit at Kocaeli Darıca Farabi Training and Research Hospital. Healthy term newborns (37-42 weeks of gestation) delivered by cesarean section will be enrolled after written informed parental consent is obtained. A total of 112 newborns will be randomly allocated in a 1:1 ratio to either the nesting intervention group or the routine care control group using Random Allocation Software.

Newborns assigned to the intervention group will be placed in a sterile cotton nesting position until the first intramuscular injection. Routine intramuscular administration of vitamin K and hepatitis B vaccine will be performed according to standard neonatal care. The control group will receive routine neonatal care without nesting. No additional invasive procedures will be performed for research purposes.

Pain, stress level, heart rate, respiratory rate, oxygen saturation, and settling time will be assessed before, during, and one minute after the injection. Breastfeeding success will be evaluated at the first breastfeeding after mother-infant reunion, at one hour after breastfeeding, and before hospital discharge using validated assessment tools. Outcome assessment will be performed by an independent assessor who is blinded to group allocation.

The primary objective of this study is to determine whether nesting reduces procedural pain and stress while improving physiological stability and breastfeeding success in term newborns delivered by cesarean section. The results are expected to contribute to evidence-based neonatal care by supporting the implementation of developmental, non-pharmacological interventions during routine newborn procedures.

研究类型

介入性

注册 (估计的)

112

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:Emine Nur Çalımlı Celep, Msc
  • 电话号码:+90 506 126 48 03
  • 邮箱:enurcalimli@gmail.com

研究联系人备份

学习地点

    • Kocaeli
      • Darıca、Kocaeli、土耳其(türkiye)
        • 招聘中
        • Kocaeli Darıca Farabi Training and Research Hospital
        • 接触:
        • 首席研究员:
          • Sevil İnal, Prof. Dr.
        • 副研究员:
          • Emine Nur Çalımlı Celep, Msc
        • 副研究员:
          • Yasemin Dinçel, Msc

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:

  • Written informed consent was obtained from the parent(s) or legal guardian(s) of the newborn.
  • Born by cesarean section.
  • Term newborn (gestational age between 37+0 and 41+6 weeks).
  • Birth weight between 2,500 g and 4,000 g.
  • Clinically stable vital signs (including heart rate, respiratory rate, and oxygen saturation).
  • No acute or chronic medical conditions.
  • No congenital anomalies.
  • No requirement for endotracheal intubation, resuscitation, or admission to the neonatal intensive care unit (NICU).
  • Scheduled to receive the first intramuscular injection after birth.

Exclusion Criteria:

  • Multiple birth (e.g., twins or higher-order multiples).
  • Administration of vitamin K or hepatitis B vaccine before completion of the study procedures.
  • Withdrawal of parental consent at any time during the study.
  • Use of a pacifier, oral sucrose, or any pharmacological or non-pharmacological pain-relief intervention before completion of the outcome assessments.
  • Discharge from the hospital or transfer to another healthcare facility before completion of the study procedures.
  • Delayed mother-newborn reunion due to maternal general anesthesia or prolonged sedation following spinal or epidural anesthesia.
  • Delayed transfer of the newborn to the mother because of prolonged surgery, intraoperative complications, or delayed postoperative stabilization.

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:Nesting Group
Term newborns delivered by cesarean section will receive the nesting intervention before and during routine intramuscular injection. Pain, stress level, and breastfeeding success will be assessed using validated outcome measures.
Nesting is a non-pharmacological positioning intervention in which the newborn is placed in a flexed, midline posture using rolled towels or positioning supports to provide containment before and during intramuscular injection. The intervention aims to reduce procedural pain and stress and improve breastfeeding success.
无干预:Standard Care Group
Term newborns delivered by cesarean section will receive routine care during intramuscular injection without the nesting intervention. Pain, stress level, and breastfeeding success will be assessed using the same outcome measures.

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
Neonatal Pain
大体时间:Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The pain/agitation component consists of five behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater pain.
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Neonatal Stress Level
大体时间:Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Neonatal stress will be assessed using the Neonatal Stress Scale. The scale consists of eight behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 16. Higher scores indicate greater neonatal stress.
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.

次要结果测量

结果测量
措施说明
大体时间
Heart Rate
大体时间:Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Heart rate will be measured in beats per minute (bpm) to evaluate the newborn's physiological response to intramuscular injection. Higher heart rate values indicate a greater physiological response to procedural stress.
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Respiratory Rate
大体时间:Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Respiratory rate will be measured in breaths per minute (breaths/min) to evaluate the newborn's physiological response to intramuscular injection. Higher respiratory rate values indicate a greater physiological response to procedural stress.
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Peripheral Oxygen Saturation
大体时间:Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage (%) to evaluate the newborn's physiological response to intramuscular injection. Higher SpO₂ values indicate better oxygenation.
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Breastfeeding Success
大体时间:At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
Breastfeeding success will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT). The BBAT consists of four items (positioning, attachment, sucking, and swallowing), each scored from 0 to 2. Total scores range from 0 to 8, with higher scores indicating better breastfeeding effectiveness.
At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).

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。

调查人员

  • 首席研究员:Sevil İnal, Prof. Dr.、Istanbul University-Cerrahpasa, Department of Midwifery

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)

2025年10月15日

初级完成 (估计的)

2026年10月15日

研究完成 (估计的)

2026年10月15日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年8月2日

首次发布 (实际的)

2026年8月5日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年8月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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