The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort
The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort: A Randomızed Controlled Study
This research will be conducted using a randomized controlled, double-blind experimental design to determine the effects of breastfeeding and kangaroo care on the pain and comfort of newborn babies before heel prick blood sampling. The study group will consist of newborn babies, and one of the observers administering the pain and comfort scores will be independent of the research participants, with the observer evaluating the babies without knowing which group they belong to.
Study Hypotheses H0a = Breastfeeding before heel prick test in newborns does not affect the baby's pain.
H1a = Breastfeeding before heel prick test in newborns reduces the baby's pain. H0b = Kangaroo care before heel prick test in newborns does not affect the baby's pain.
H1b = Kangaroo care before heel prick test in newborns reduces the baby's pain. H0c = Breastfeeding before heel prick test in newborns does not affect the baby's comfort level.
H1c = Breastfeeding before heel prick test in newborns increases the baby's comfort level.
H0d = Kangaroo care before heel prick test in newborns does not affect the baby's comfort level.
H1d = Kangaroo care before heel prick test in newborns increases the baby's comfort level.
The research is planned to be conducted at the Obstetrics and Gynecology Department of Sivas Cumhuriyet University Women's and Children's Hospital in Sivas city center between February 1, 2025 and March 1, 2026.
The study population will consist of newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital. The study sample will comprise newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital who meet the study criteria. The study (breastfeeding group, kangaroo care group) and control groups will consist of a total of 120 newborns.
The following instruments will be used to collect research data: Newborn and Parent Demographic Information Form, Neonatal Infant Pain Scale (NIPS), Neonatal Comfort Behavior Scale, informed consent form, and Blinded Evaluator NIPS form. The study will also utilize a pulse oximeter, a camera, and a stopwatch.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Merkez
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Sivas, Merkez, 터키 (Türkiye), 58030
- Sivas Cumhuriyet Üniversitesi Sağlık Hizmetleri Uygulama ve Araştırma Hastanesinde Kadın Hastalıkları Obs-tetri servisi
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Parental consent must be obtained in accordance with the participant information and consent form
- The baby must be term, between 37-42 weeks gestation
- Birth weight must be 2500 grams or more
- The mother must be present with the baby
- The baby must be healthy (no physical, metabolic, or genetic diseases, no surgical procedures have been performed)
- There must be no condition that prevents pain assessment (neuromotor developmental delay, etc.)
- The baby must not have undergone any invasive procedures other than routine interventions
- The baby must have been born by cesarean section
- The mother must speak and understand Turkish fluently
Exclusion Criteria:
- Pre-procedure NIPS score of 3 or higher
- Lack of parental consent based on participant information and consent form
- Newborn born before 37 weeks of gestation
- Birth weight under 2500 grams
- Unstable general condition
- Vaginal delivery
- Invasive procedures performed on the baby other than routine procedures
- Failure to obtain heel prick blood on the first attempt
- Mother not speaking Turkish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 요인 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: This is the group where the baby is breastfed before the heel prick blood test. In this group, the e
Breastfeeding Group (Group 1) Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test.
Physiological parameters, NIPS, and comfort behavior will be evaluated before, during and after the procedure.
In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test.
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Before the heel prick blood test, a newborn information form and a parent identification form will be completed.
Parents will be given information about breastfeeding, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure.
Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test.
Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure.
In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test.
The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator.
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실험적: This group receives skin-to-skin contact (kangaroo care) before the heel prick blood test on the bab
Kangaroo Care Group (Group 2) Each baby in the group will be given 30 minutes of kangaroo care before heel prick blood is taken.
Physiological parameters, NIPS (Neural Network Imaging System) scores, and comfort behavior will be evaluated before, during, and after the procedure.
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Before the procedure, a newborn information form and a parent identification form will be completed.
Parents will be given information about kangaroo care, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure.
Each baby in the group will be provided with kangaroo care for 30 minutes before the heel prick blood sample is taken.
Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure.
In addition, the duration of the newborn's crying will be recorded with a stopwatch during the procedure.
The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator.
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실험적: This is the group that receives standard care.
Control Group (Group 3) Physiological parameters, NIPS (Neuroprocedure Testing System), and comfort behavior will be evaluated before, during, and after the procedure.
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No intervention will be performed.
Routine hospital procedure will be applied.Physiological parameters, NIPS (Neuro-Visual Imaging System), and comfort behavior will be evaluated before, during, and after the procedure.
Additionally, the newborn's crying duration will be recorded using a stopwatch during the procedure.
The newborn will also be recorded on camera during the procedure for evaluation by a blind evaluator.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Determining the appropriate interval for breastfeeding and kangaroo care in newborns before heel prick blood sampling, as well as assessing pain and temperature.
기간: about a year
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Newborn Infant Pain Scale Assessment Form: The NIPS Form is used to assess pain and consists of six behavioral responses: facial expression, emission pattern, arms, fullness, and volume.
Crying performance is given three points (0-1-2), while other behaviors are given only two points (0-1).
The total score is calculated based on the Neonatal Pain Scale, with a maximum score of 7 and a minimum score of 0. A NIPS score between 0-2 indicates no pain and requires no intervention.
A pain score between 3-4 indicates moderate acoustic pain, and complementary and alternative interventions are applied.
A pain score above four suggests complementary and alternative Neonatal Comfort Behavior Scale (NICS): Each item on the scale is scored from 1 to 5. The overall score is used for evaluation.
The lowest possible score on the Newborn Comfort Behavior Scale is 6, and the highest is 30.
A total score between 9-13 indicates that the baby is comfortable, while a score between 14-30 indicates that th
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about a year
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공동 작업자 및 조사자
수사관
- 연구 책임자: FERDAĞ YILDIRIM, SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK HİZMETLERİ MESLEK YÜKSEKOKULU
- 연구 책임자: EMİNE ALTUN YILMAZ, SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ HEMŞİRELİK BÖLÜMÜ
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CU-SBF-BSB-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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