Effect of Earmuffs on Physiological Stability, Sleep-Wake States, and Weight Gain in Preterm Neonates
Effect of Earmuffs on Physiological Stability, Sleep-Wake States, and Weight Gain in Preterm Neonates: A Randomized Controlled Trial
This study aims to evaluate the effect of earmuffs on physiological stability, sleep-wake states, and weight gain in preterm neonates admitted to neonatal intensive care units (NICUs). The study will compare preterm neonates receiving earmuffs in addition to routine nursing care with those receiving routine nursing care alone. Physiological stability will be assessed by measuring heart rate, respiratory rate, oxygen saturation, and body temperature. Sleep-wake states will be assessed using the Anderson Behavioral State Scoring (ABSS) system, and weight gain will be evaluated through body-weight measurements. The study may provide evidence on the potential role of earmuffs as a supportive nursing intervention for preterm neonates.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Preterm neonates admitted to neonatal intensive care units (NICUs) may be exposed to environmental noise generated by monitoring devices, alarms, respiratory support equipment, and routine staff activities. Because preterm neonates have immature physiological and neurological systems, protecting their developmental environment is an important aspect of neonatal supportive care.
Earmuffs may help reduce neonates' exposure to environmental noise. However, their effects on physiological stability, sleep-wake states, and weight gain need further evaluation. This study will investigate these outcomes to contribute evidence on the potential role of earmuffs in supportive nursing care for preterm neonates.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Marwa Y Alwan
- Numer telefonu: +9647810597443
- E-mail: marwa.yasir2504m@conursing.uobaghdad.edu.iq
Lokalizacje studiów
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Nasiriyah, Irak
- Al-Haboubi Teaching Hospital
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Kontakt:
- Marwa Alwan, MSc Student
- Numer telefonu: +9647810597443
- E-mail: marwa.yasir2504m@conursing.uobaghdad.edu.iq
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Preterm neonates born at 28-36 completed weeks of gestation. 2. Neonates admitted to the NICU and requiring incubator care. 3. Clinically stable preterm neonates.
Exclusion Criteria:
- Neonates requiring mechanical ventilation. 2. Neonates with congenital anomalies 3. Neonates with neurological or brain disorders 4. Neonates with severe sepsis
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Earmuff Intervention Group
Preterm neonates receive earmuffs in addition to routine nursing care. |
External neonatal earmuffs will be used as a non-pharmacological intervention to reduce preterm neonates' exposure to environmental noise in the neonatal intensive care unit. The earmuffs will be applied according to the manufacturer's instructions and the study protocol. The intervention group will receive earmuffs in addition to routine neonatal care. |
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Brak interwencji: Control Group
Preterm neonates receive routine nursing care alone, without the earmuff intervention. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sleep-Wake States in Preterm Neonates
Ramy czasowe: Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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(ABSS) system.Sleep-wake states will be assessed using the Anderson Behavioral State Scale (ABSS). The scale ranges from 1 to 12. Scores from 1-4 indicate sleep states, 5-7 indicate awake states, and 8-12 indicate restless states. Higher scores indicate a worse outcome (more restless/fussy), while lower scores indicate a better outcome (deep sleep). |
Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Heart Rate in Preterm Neonates
Ramy czasowe: Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Heart rate will be measured in beats per minute (bpm) using a pulse oximeter. |
Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Respiratory Rate in Preterm Neonates
Ramy czasowe: intervention.Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Respiratory rate will be measured by direct observation for one minute (counting breaths per minute). |
intervention.Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Oxygen Saturation (SpO2) in Preterm Neonates
Ramy czasowe: Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Oxygen saturation will be measured as a percentage (%) using a pulse oximeter. |
Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Weight Gain in Preterm Neonates
Ramy czasowe: Baseline (Day 1), Day 5 (end of intervention), and Day 10 (follow-up).
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Body weight will be measured in grams using a calibrated neonatal weighing scale, and weight change will be assessed. |
Baseline (Day 1), Day 5 (end of intervention), and Day 10 (follow-up).
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UOB-EARMUFFS-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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