- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07563374
Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction (MİDWİFERY)
The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial
연구 개요
상세 설명
This randomized controlled trial is designed to evaluate the effect of continuous birth support provided by student midwives on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted in a maternity hospital setting.
Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be informed about the study and asked to provide written informed consent before participation. After enrollment, participants will be randomly assigned to either an experimental group receiving continuous birth support or a control group receiving routine intrapartum care.
Participants in the experimental group will receive continuous birth support provided by trained student midwives in addition to routine intrapartum care. The intervention will consist of structured breathing exercises guided by student midwives, including slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions. The support will begin at admission to the labor ward and continue throughout labor until birth, following a standardized intervention protocol.
Participants in the control group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital, including regular maternal and fetal monitoring and clinical care by midwives and obstetric staff. No structured breathing exercise program will be provided.
The primary outcome of the study is labor pain intensity, assessed using the Visual Analog Scale (VAS). Pain will be measured at two time points: at admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.
The secondary outcome is birth satisfaction, assessed within 24 hours postpartum using the Birth Satisfaction Scale-Revised (BSS-R). he study aims to determine whether continuous birth support provided by student midwives is associated with reduced labor pain intensity and increased birth satisfaction compared to routine intrapartum care.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Döşemealti
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Antalya, Döşemealti, 터키 (Türkiye), 07190
- Antalya
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Pregnant women aged 18 years or older
- Singleton pregnancy
- Gestational age ≥ 37 completed weeks
- Low-risk pregnancy
- Planned vaginal birth
- Admitted to the labor ward in the latent or early active phase of labor
- No pharmacological analgesia before the first pain assessment
- Ability to communicate and provide written informed consent
Exclusion Criteria:
- High-risk pregnancy requiring continuous medical or obstetric intervention
- Planned cesarean section
- Multiple pregnancy
- Known fetal anomaly
- Use of pharmacological analgesia (e.g., epidural anesthesia, systemic opioids) before baseline pain assessment
- Obstetric complications requiring emergency intervention at admission (e.g., fetal distress, placental abruption, cord prolapse)
- Inability to cooperate with breathing exercises
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Continuous Birth Support by Student Midwives
Participants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor.
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Continuous emotional, physical, informational, and advocacy support provided by senior student midwifery students under supervision during labor, including positioning, breathing techniques, massage, relaxation techniques, and psychological support.
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다른: Routine Intrapartum Care
Participants received routine intrapartum care without continuous one-to-one birth support.
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Standard intrapartum care practices routinely provided in the study setting.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in labor pain intensity from baseline to active labor.
기간: Baseline and during active labor, up to 24 hours
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Labor pain intensity will be assessed using the Visual Analog Scale, a 10-centimeter horizontal line anchored with "no pain" and "worst pain imaginable."
Scores range from 0 to 10. Higher scores indicate greater pain intensity.
The outcome will be the change in participant-reported VAS score from baseline to active labor.
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Baseline and during active labor, up to 24 hours
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Birth satisfaction measured by the Birth Satisfaction Scale-Revised
기간: Up to 24 hours postpartum (Day 1)
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Birth satisfaction will be assessed using the Birth Satisfaction Scale-Revised, a validated self-report questionnaire measuring women's satisfaction with the childbirth experience.
The total score ranges from 0 to 40.
Higher scores indicate greater birth satisfaction.
The total scale score will be used as the outcome measure.
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Up to 24 hours postpartum (Day 1)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Obstetric Interventions
기간: During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
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Frequency of obstetric interventions during labor, including episiotomy, amniotomy, and labor augmentation.
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During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
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공동 작업자 및 조사자
수사관
- 수석 연구원: Seda Serhatlioglu, Doctorate, Antalya Bilim University
간행물 및 유용한 링크
일반 간행물
- Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2017;7:CD003766. doi:10.1002/14651858.CD003766.pub6
- Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2013;7:CD003766. doi:10.1002/14651858.CD003766.pub5
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
- 2025-SS
- 1919B012325051 (기타 보조금/기금 번호: TUBITAK 2209-A Undergraduate Research Support Program)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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