Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns | NCT07748520

NCT07748520

Overview

NCT ID: NCT07748520
Lead Sponsor: Istanbul University - CerrahpasaOTHER
Official Title: The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
Brief Summary: 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Oct 15, 2025Actual
Primary Completion Date: Oct 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 112Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Emine Nur Çalımlı Celep, MScContact
enurcalimli@gmail.com

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