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Effect of Earmuffs on Physiological Stability, Sleep-Wake States, and Weight Gain in Preterm Neonates

11 november 2026 uppdaterad av: Marwa Yasir alwan, University of Baghdad

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 dag till 2 veckor (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Earmuff Intervention Group

Preterm neonates receive earmuffs in addition to routine nursing care.
Enhet: Neonatal Earmuffs

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.
Inget ingripande: Control Group

Preterm neonates receive routine nursing care alone, without the earmuff intervention.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sleep-Wake States in Preterm Neonates
Tidsram: 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.

(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.
Heart Rate in Preterm Neonates
Tidsram: 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.

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.
Respiratory Rate in Preterm Neonates
Tidsram: 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.

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.
Oxygen Saturation (SpO2) in Preterm Neonates
Tidsram: 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.

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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Weight Gain in Preterm Neonates
Tidsram: Baseline (Day 1), Day 5 (end of intervention), and Day 10 (follow-up).

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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Baghdad

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

20 november 2026

Primärt slutförande (Beräknad)

20 februari 2027

Avslutad studie (Beräknad)

15 juli 2027

Studieregistreringsdatum

Först inskickad

4 november 2026

Först inskickad som uppfyllde QC-kriterierna

11 november 2026

Första postat (Faktisk)

12 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UOB-EARMUFFS-2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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