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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Emine Nur Çalımlı Celep, Msc
- Numéro de téléphone: +90 506 126 48 03
- E-mail: enurcalimli@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Yasemin Dinçel, MSc
- Numéro de téléphone: +90 545 939 49 26
- E-mail: yasemindincel96@gmail.com
Lieux d'étude
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Kocaeli
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Darıca, Kocaeli, Turquie (Türkiye)
- Recrutement
- Kocaeli Darıca Farabi Training and Research Hospital
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Contact:
- Emine Nur Çalımlı Celep, Msc
- Numéro de téléphone: +90 506 126 48 03
- E-mail: enurcalimli@gmail.com
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Chercheur principal:
- Sevil İnal, Prof. Dr.
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Sous-enquêteur:
- Emine Nur Çalımlı Celep, Msc
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Sous-enquêteur:
- Yasemin Dinçel, Msc
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
|
|
Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Neonatal Pain
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heart Rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sevil İnal, Prof. Dr., Istanbul University-Cerrahpasa, Department of Midwifery
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- NESTING-2025-09
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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