- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07406607
분만실 내 아버지의 존재가 산모의 회복 질에 미치는 영향
척추마취 하 선택적 제왕절개 중 아버지의 존재가 산모의 회복 질에 미치는 영향
The presence of a partner to support the mother during cesarean and vaginal deliveries is a well-established practice in most countries worldwide. It is evident that allowing the partner into the operating room during a cesarean section provides psychosocial benefits for both the mother and the partner. This study aims to investigate the effect of the presence of partner in the operating room on quality of recovery of parturients at the postoperative period.
연구 개요
상태
정황
상세 설명
This prospective study evaluates the impact of the partner's presence in the operating room during elective cesarean sections on maternal anxiety, postoperative recovery, and surgeon stress levels. Patients are allocated into two groups: Partner Present and Partner Absent. Primary outcome is obstetric quality of recovery scale (ObsQoR 10) at the postoperative first day. Secondary outcomes include maternal pain (assessed via VAS at 6-hour intervals for the first 24 hours) and anxiety levels (STAI-T/S administered to couples preoperatively and STAI-S postoperatively) and ObsQoR-10 that will be evaluated at the postoperative 3rd and 7th days.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Karaman, 터키 (Türkiye), 70200
- Karaman Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients scheduled for an elective cesarean section.
- Patients and their partners must be literate in Turkish (able to read and write) to accurately complete the study questionnaires
- Patients and their partners must be willing and able to provide written informed consent
- Healthy pregnant women with no additional chronic or systemic diseases (comorbidities)
- The operating surgeon must have at least 5 years of professional experience and no chronic health conditions.
Exclusion Criteria:
- Patients undergoing emergency cesarean sections.
- Patients with any known chronic or systemic additional diseases
- Surgeons with any known chronic or systemic diseases.
- Individuals unable to read or understand the Turkish questionnaires (implied by the literacy requirement).
- Patients with American Society of Anesthesiologists (ASA) classification of 3 or more
- Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse
- Patients who have refused spinal anesthesia, or those in whom it is contraindicated.
- Pregnancy with preeclampsia or eclampsia
- Pregnancy with gestational diabetes mellitus or diabetes mellitus
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 파트너 동반
|
The patient's partner is admitted to the operating room after sterile preparations are complete. The partner remains with the patient to provide physical and emotional support during the cesarean section operation |
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활성 비교기: 파트너 부재
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The patient undergoes the elective cesarean section according to standard hospital protocols. The partner is not present in the operating room during the surgery. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Obstetric Quality of Recovery-10 (ObsQoR-10) Score
기간: Post-operative 24th hour,
|
The ObsQoR-10 questionnaire will be used to assess the quality of maternal recovery after the cesarean section. The scale consists of 10 items, where patients rate each item from 0 (never) to 10 (always). Higher scores indicate a better quality of recovery. |
Post-operative 24th hour,
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Surgeon's Physiological Stress Level (Heart Rate)
기간: Intra-operative (during the entire duration of the cesarean section)
|
The operating surgeon's heart rate variability will be recorded using a rhythm Holter device during the surgery. A heart rate exceeding 100 beats per minute (bpm) will be considered an indicator of increased stress. |
Intra-operative (during the entire duration of the cesarean section)
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maternal and Partner Anxiety Levels (STAI-T and STAI-S)
기간: Pre-operative and Post-operative (within the first 6 hours)
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The State-Trait Anxiety Inventory (STAI) will be used to measure the patient's and partner's anxiety levels. Both the Trait (STAI-T) and State (STAI-S) components will be administered. Scores range from 20 to 80, with higher scores indicating greater anxiety. |
Pre-operative and Post-operative (within the first 6 hours)
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- faruk
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
- E-11095095-050.04-253322
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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