Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
The Effect of Eye Covering and White Noise During Nasogastric Tube Insertion on Comfort, Pain, Stress, and Physiological Parameters in Preterm Infants
This study aims to evaluate the effects of eye covering and white noise during nasogastric tube insertion on comfort, pain, stress, and physiological parameters in preterm infants. A total of 90 preterm infants will be randomly assigned to one of three groups: eye covering, white noise, or combined eye covering and white noise. Comfort, pain, stress, heart rate, respiratory rate, and oxygen saturation will be assessed before, during, and after nasogastric tube insertion.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aysegu Simsek, PhD
- Numéro de téléphone: +905413155774
- E-mail: asimsek@marmara.edu.tr
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Bağcılar Training and Research Hospital
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Chercheur principal:
- Aysegul Simsek, PhD
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Contact:
- Aysegul Simsek, PhD
- Numéro de téléphone: +905413155774
- E-mail: asimsek@marmara.edu.tr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Written and verbal parental consent for participation
- Gestational age between 32 and 36 weeks
- Birth weight of 1500 g or greater
- Apgar score of 6 or greater at 1 and 5 minutes
- Postnatal age of 3 days or older
- Hospitalization in the neonatal intensive care unit for more than 24 hours
- No sedation
- No procedures such as peripheral intravenous catheter insertion, blood sampling, or aspiration within 1 hour before enrollment
- Clinically stable condition
Exclusion Criteria:
- Central nervous system problems such as intracranial hemorrhage, seizures, or hypertonia
- Congenital or genetic anomalies
- Receiving phototherapy
- Respiratory distress requiring oxygen support
- Receiving mechanical ventilation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Eye Covering
Preterm infants will receive eye covering beginning 15 minutes before nasogastric tube insertion. The eye covering will remain in place during the procedure and for 15 minutes after the procedure. |
Eye covering will be applied 15 minutes before nasogastric tube insertion and will remain in place during the procedure and for 15 minutes after the procedure. |
|
Expérimental: White Noise
Preterm infants will receive white noise at 45 dB beginning 15 minutes before nasogastric tube insertion. White noise will continue during the procedure and for 15 minutes after the procedure. |
White noise at 45 dB will be started 15 minutes before nasogastric tube insertion and will continue during the procedure and for 15 minutes after the procedure. |
|
Expérimental: Eye Covering and White Noise
Preterm infants will receive both eye covering and white noise beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure. |
Eye covering and white noise at 45 dB will be applied together beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neonatal Comfort Level Assessed Using the COMFORTneo Scale
Délai: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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Neonatal comfort will be assessed using the COMFORTneo Scale before, during, and after nasogastric tube insertion. COMFORTneo is used to assess comfort and distress in neonates. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
Délai: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Neonatal pain and stress will be assessed using the ALPS-Neo Neonatal Pain and Stress Assessment Scale before, during, and after nasogastric tube insertion. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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|
Heart Rate
Délai: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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Heart rate will be measured using a pulse oximeter and recorded as beats per minute. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
|
Respiratory Rate
Délai: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Respiratory rate will be measured and recorded as breaths per minute. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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Oxygen Saturation
Délai: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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Peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Aysegul Simsek, PhD, Marmara University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
- AS-NICU-NG-2026-01
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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