- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07820904
THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
This randomized controlled trial aims to evaluate the effects of 360-degree video-supported upright birth position education on fear of childbirth, childbirth self-efficacy, birth satisfaction, and perineal trauma among primiparous pregnant women. Eligible participants will be randomly assigned to one of three intervention groups or a control group. In addition to routine antenatal care, participants in the intervention groups will receive 360-degree video-supported education on one of three upright birth positions: use of a Pilates ball, birth dance, or squatting. Participants in the control group will receive routine antenatal care only.
The study will examine whether 360-degree video-supported education can help primiparous women prepare for childbirth, reduce fear of childbirth, improve childbirth self-efficacy and birth satisfaction, and reduce the occurrence of perineal trauma. The outcomes of the three intervention groups will also be explored to determine whether the effects differ according to the type of upright birth position.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rozerin Balcı
- 전화번호: +905398339950
- 이메일: rbalci@beu.edu.tr
연구 장소
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Bitlis
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Bitlis, Bitlis, 터키 (Türkiye)
- Bitlis State Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Having signed the Informed Consent Form.
- Being able to speak and understand Turkish.
- Being literate.
- Having no impairment that would interfere with auditory, visual, or cognitive communication.
- Being primiparous.
- Having a singleton live fetus.
- Being between 28 and 32 weeks of gestation.
- Having a fetus in cephalic presentation.
- Planning a vaginal birth.
- Being enrolled and randomized before the onset of labor.
- Being able to use a smartphone or tablet.
- Having sufficient physical and cognitive ability to watch the 360° video education.
- Having moderate fear of childbirth, defined as a score of 38 or higher on the W-DEQ-A.
Exclusion Criteria:
- Refusal to participate in the study or withdrawal from the study.
- Development of a serious maternal or fetal complication during labor that prevents continuation of the study intervention.
- Giving birth by elective or emergency cesarean section.
- Loss of study data during the research process.
- Giving birth outside Bitlis State Hospital.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Pilates Ball Group
Participants will receive 360° video-supported education on upright birth positions using a Pilates ball.
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Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
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실험적: Birth Dance Group
Participants will receive 360° video-supported education on upright birth positions using birth dance.
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Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
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실험적: Squatting Group
Participants will receive 360° video-supported education on upright birth positions using supported squatting.
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Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
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간섭 없음: Control Group
Participants will receive routine antenatal care without the 360° video-supported upright birth positions education during the study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Childbirth Fear Score
기간: From baseline (before randomization) to 24-48 hours after childbirth
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Childbirth fear will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire-A (W-DEQ-A) before randomization and the W-DEQ-B after childbirth.
The change in childbirth fear score will be compared between the study groups.
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From baseline (before randomization) to 24-48 hours after childbirth
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Childbirth Self-Efficacy Score
기간: From baseline (before randomization) to 24-48 hours after childbirth
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Childbirth self-efficacy will be assessed using the Childbirth Self-Efficacy Scale before randomization and within 24-48 hours after childbirth.
The change in score will be compared between the study groups.
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From baseline (before randomization) to 24-48 hours after childbirth
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Birth Satisfaction Score
기간: Within 24-48 hours after childbirth
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Birth satisfaction will be assessed using the Birth Satisfaction Scale Short Form within 24-48 hours after childbirth.
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Within 24-48 hours after childbirth
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Perineal Trauma
기간: Immediately after childbirth
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Perineal trauma will be assessed immediately after childbirth during routine clinical evaluation and classified according to the Sultan classification as intact perineum, episiotomy, or first-, second-, third-, or fourth-degree perineal laceration.
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Immediately after childbirth
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공동 작업자 및 조사자
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
- BEU-MIDWIFERY-VIRTUAL-BIRTH-20
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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