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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marwa Y Alwan
- Phone Number: +9647810597443
- Email: marwa.yasir2504m@conursing.uobaghdad.edu.iq
Study Locations
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Nasiriyah, Iraq
- Al-Haboubi Teaching Hospital
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Contact:
- Marwa Alwan, MSc Student
- Phone Number: +9647810597443
- Email: marwa.yasir2504m@conursing.uobaghdad.edu.iq
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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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No Intervention: Control Group
Preterm neonates receive routine nursing care alone, without the earmuff intervention. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep-Wake States in Preterm Neonates
Time Frame: 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
Time Frame: 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.
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Respiratory Rate in Preterm Neonates
Time Frame: 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.
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Oxygen Saturation (SpO2) in Preterm Neonates
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Gain in Preterm Neonates
Time Frame: 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).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOB-EARMUFFS-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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