The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Neonatal Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to either the nesting intervention group or the routine care control group. Outcomes will be compared between the two parallel groups.
入排标准
- 年龄范围
- — 至 30 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Nesting (Behavioral)
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.
结局指标
主要结局
Neonatal Pain
时间窗: 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.
Neonatal Stress Level
时间窗: 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.
次要结局
- Heart Rate(Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.)
- Respiratory Rate(Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.)
- Peripheral Oxygen Saturation(Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.)
- Breastfeeding Success(At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).)
研究者
Emine Nur Çalımlı Celep
PhD Student
Istanbul University - Cerrahpasa