Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns (NESTING)
The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Painful procedures performed during the first hours after birth, particularly intramuscular vitamin K and hepatitis B injections, are associated with significant pain and stress responses in newborns. Although several non-pharmacological interventions have been recommended to minimize procedural pain, evidence regarding the effectiveness of nesting in healthy term newborns delivered by cesarean section remains limited.
This study is designed as a prospective, single-center, parallel-group, randomized controlled trial. The study will be conducted in the newborn observation room of the Delivery Unit at Kocaeli Darıca Farabi Training and Research Hospital. Healthy term newborns (37-42 weeks of gestation) delivered by cesarean section will be enrolled after written informed parental consent is obtained. A total of 112 newborns will be randomly allocated in a 1:1 ratio to either the nesting intervention group or the routine care control group using Random Allocation Software.
Newborns assigned to the intervention group will be placed in a sterile cotton nesting position until the first intramuscular injection. Routine intramuscular administration of vitamin K and hepatitis B vaccine will be performed according to standard neonatal care. The control group will receive routine neonatal care without nesting. No additional invasive procedures will be performed for research purposes.
Pain, stress level, heart rate, respiratory rate, oxygen saturation, and settling time will be assessed before, during, and one minute after the injection. Breastfeeding success will be evaluated at the first breastfeeding after mother-infant reunion, at one hour after breastfeeding, and before hospital discharge using validated assessment tools. Outcome assessment will be performed by an independent assessor who is blinded to group allocation.
The primary objective of this study is to determine whether nesting reduces procedural pain and stress while improving physiological stability and breastfeeding success in term newborns delivered by cesarean section. The results are expected to contribute to evidence-based neonatal care by supporting the implementation of developmental, non-pharmacological interventions during routine newborn procedures.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emine Nur Çalımlı Celep, Msc
- Número de teléfono: +90 506 126 48 03
- Correo electrónico: enurcalimli@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Yasemin Dinçel, MSc
- Número de teléfono: +90 545 939 49 26
- Correo electrónico: yasemindincel96@gmail.com
Ubicaciones de estudio
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Kocaeli
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Darıca, Kocaeli, Turquía (Türkiye)
- Reclutamiento
- Kocaeli Darıca Farabi Training and Research Hospital
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Contacto:
- Emine Nur Çalımlı Celep, Msc
- Número de teléfono: +90 506 126 48 03
- Correo electrónico: enurcalimli@gmail.com
-
Investigador principal:
- Sevil İnal, Prof. Dr.
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Sub-Investigador:
- Emine Nur Çalımlı Celep, Msc
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Sub-Investigador:
- Yasemin Dinçel, Msc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Nesting Group
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.
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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.
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Sin intervención: Standard Care Group
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neonatal Pain
Periodo de tiempo: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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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.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Neonatal Stress Level
Periodo de tiempo: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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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.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart Rate
Periodo de tiempo: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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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.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Respiratory Rate
Periodo de tiempo: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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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.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Peripheral Oxygen Saturation
Periodo de tiempo: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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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.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Breastfeeding Success
Periodo de tiempo: At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
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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.
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At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sevil İnal, Prof. Dr., Istanbul University-Cerrahpasa, Department of Midwifery
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NESTING-2025-09
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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