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

NCT07748520 | Recruiting

• 1 other identifier: NESTING-2025-09
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn Pain; Newborn Stress; Breastfeeding Success in Newborns

Keywords

Nesting; Term Newborn; Cesarean Section; Intramuscular Injection; Newborn Pain; Newborn Stress; Breastfeeding Success

Outcome Measures

Primary Outcomes (2)

• Neonatal Pain

  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

  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.

Secondary Outcomes (4)

• 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).

Study Arms (2)

Nesting Group

EXPERIMENTAL

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.

Behavioral: Nesting

Standard Care Group

NO INTERVENTION

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.

Interventions

Nesting BEHAVIORAL

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.

Nesting Group

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Kocaeli Darıca Farabi Training and Research Hospital

Darıca, Kocaeli, Turkey (Türkiye)

RECRUITING

Study Officials

• Sevil İnal, Prof. Dr.

  Istanbul University-Cerrahpasa, Department of Midwifery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Nur Çalımlı Celep, MSc

CONTACT

+90 506 126 48 03; enurcalimli@gmail.com

Yasemin Dinçel, MSc

CONTACT

+90 545 939 49 26; yasemindincel96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 5, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)