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

Recruiting now · Not applicable

Conditions studied: Newborn Pain, Newborn Stress, Breastfeeding Success in Newborns

In brief

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.

Key facts

Study ID

NCT07748520

Run by

Istanbul University - Cerrahpasa

People needed

112

Starts

2025-10-15

Expected to finish

2026-10-15

Last updated by the study team

2026-08-05

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kocaeli Darıca Farabi Training and Research Hospital — Darıca, Kocaeli, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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