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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Aysegu Simsek, PhD
- Telefonnummer: +905413155774
- E-post: asimsek@marmara.edu.tr
Studiesteder
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Istanbul, Tyrkia (Türkiye)
- Bağcılar Training and Research Hospital
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Hovedetterforsker:
- Aysegul Simsek, PhD
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Ta kontakt med:
- Aysegul Simsek, PhD
- Telefonnummer: +905413155774
- E-post: asimsek@marmara.edu.tr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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. |
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Eksperimentell: 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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Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Neonatal Comfort Level Assessed Using the COMFORTneo Scale
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Aysegul Simsek, PhD, Marmara University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- AS-NICU-NG-2026-01
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