Nesting During the First Injection in Cesarean-Born Term Newborns
Official title: The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
Run by Istanbul University - Cerrahpasa · NCT07748520 · Data updated 2026-11-12
This randomized trial tests whether placing healthy term babies born by C-section in a nesting position before their first intramuscular injections reduces pain and stress and supports breastfeeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 30 Minutes |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Darıca, Kocaeli) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | October 15, 2026 |
| Study ends | October 15, 2026 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07748520 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy term newborns (37+0 to 41+6 weeks) born by cesarean section, 2,500–4,000 g, clinically stable, with parental consent, and scheduled for the first intramuscular injection.
✕Probably not a fit
Newborns not meeting eligibility or whose procedures differ from standard care may not experience benefit, and some may show no measurable difference in pain or stress.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center randomized trial assigns 112 healthy term newborns delivered by cesarean section to either a nesting intervention or routine care. The nesting group stays in a sterile cotton nesting position until the first intramuscular injection (vitamin K and hepatitis B) is given, while the control group receives standard care. Pain, stress, heart rate, respiratory rate, oxygen saturation, and settling time are measured with validated tools to see if nesting lowers procedural pain and stress and improves breastfeeding readiness. No invasive procedures are performed for research beyond standard neonatal care. The study explores a simple, non-drug approach to improve neonatal comfort during early care.
Why it matters
Potential benefit: If positive, nesting could be a quick, non-pharmacological way to lessen pain and stress from injections and potentially support breastfeeding.
How similar studies have gone: Prior non-pharmacological approaches have shown variable effects; nesting for injections in cesarean-born term newborns is a novel application with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Kocaeli Darıca Farabi Training and Research Hospital
Darıca, Kocaeli, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Sevil İnal, Prof. Dr. — Istanbul University-Cerrahpasa, Department of Midwifery
- Study coordinator: Emine Nur Çalımlı Celep, MSc
- Email: enurcalimli@gmail.com
- Phone: +90 506 126 48 03
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.