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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Aysegu Simsek, PhD
- 전화번호: +905413155774
- 이메일: asimsek@marmara.edu.tr
연구 장소
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Istanbul, 터키 (Türkiye)
- Bağcılar Training and Research Hospital
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수석 연구원:
- Aysegul Simsek, PhD
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연락하다:
- Aysegul Simsek, PhD
- 전화번호: +905413155774
- 이메일: asimsek@marmara.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Neonatal Comfort Level Assessed Using the COMFORTneo Scale
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
기간: 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
기간: 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
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Respiratory Rate
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Aysegul Simsek, PhD, Marmara University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AS-NICU-NG-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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