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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Marwa Y Alwan
- 전화번호: +9647810597443
- 이메일: marwa.yasir2504m@conursing.uobaghdad.edu.iq
연구 장소
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Nasiriyah, 이라크
- Al-Haboubi Teaching Hospital
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연락하다:
- Marwa Alwan, MSc Student
- 전화번호: +9647810597443
- 이메일: marwa.yasir2504m@conursing.uobaghdad.edu.iq
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
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디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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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간섭 없음: Control Group
Preterm neonates receive routine nursing care alone, without the earmuff intervention. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sleep-Wake States in Preterm Neonates
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Weight Gain in Preterm Neonates
기간: 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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연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
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마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- UOB-EARMUFFS-2026
개별 참가자 데이터(IPD) 계획
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