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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Aysegu Simsek, PhD
- Telefoonnummer: +905413155774
- E-mail: asimsek@marmara.edu.tr
Studie Locaties
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Istanbul, Turkije (Türkiye)
- Bağcılar Training and Research Hospital
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Hoofdonderzoeker:
- Aysegul Simsek, PhD
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Contact:
- Aysegul Simsek, PhD
- Telefoonnummer: +905413155774
- E-mail: asimsek@marmara.edu.tr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
|
Experimenteel: 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. |
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Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Neonatal Comfort Level Assessed Using the COMFORTneo Scale
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
Tijdsspanne: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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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
Tijdsspanne: 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
Tijdsspanne: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
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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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Aysegul Simsek, PhD, Marmara University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- AS-NICU-NG-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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