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
This trial accepts healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Nesting
BehavioralNesting 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Heart Rate
Heart rate will be measured in beats per minute (bpm) to evaluate the newborn's physiological response to intramuscular injection. Higher heart rate values indicate a greater physiological response to procedural stress.
Respiratory Rate
Respiratory rate will be measured in breaths per minute (breaths/min) to evaluate the newborn's physiological response to intramuscular injection. Higher respiratory rate values indicate a greater physiological response to procedural stress.
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage (%) to evaluate the newborn's physiological response to intramuscular injection. Higher SpO₂ values indicate better oxygenation.
Breastfeeding Success
Breastfeeding success will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT). The BBAT consists of four items (positioning, attachment, sucking, and swallowing), each scored from 0 to 2. Total scores range from 0 to 8, with higher scores indicating better breastfeeding effectiveness.
Sponsors and contacts
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