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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorIstanbul University - Cerrahpasa

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nesting

Treatment groups

112 Participants
are divided into 2 treatment groups