- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07628660
Assessment of Female Sexual Function Index (FSFI) Scores at 1 Month After Endometrial Sampling Performed Under Sedo-Analgesia or Local Anesthesia (FSFI-ENDO)
Evaluation of One-Month Female Sexual Function Index (FSFI) Scores in Women Undergoing Endometrial Sampling Under Sedo-Analgesia Versus Local Anesthesia
Endometrial sampling is a commonly performed gynecological procedure used for the diagnosis of abnormal uterine bleeding and endometrial abnormalities. Different anesthetic techniques may be used during the procedure, including sedo-analgesia and local anesthesia.
The purpose of this prospective observational study is to evaluate whether the anesthetic technique used during endometrial sampling affects female sexual function one month after the procedure. Female sexual function will be assessed using the validated Female Sexual Function Index (FSFI) questionnaire.
A total of 210 women undergoing endometrial sampling at Prof. Dr. Cemil Taşcıoğlu City Hospital will be enrolled. Participants will be assigned to groups according to the anesthetic technique used during their routine clinical care. FSFI scores obtained at the one-month follow-up visit will be compared between women who underwent the procedure under sedo-analgesia and those who received local anesthesia.
Secondary analyses will include comparison of FSFI scores according to symptom status and histopathological diagnosis.
The findings of this study may contribute to a better understanding of the impact of anesthetic techniques on postoperative sexual health and quality of life in women undergoing gynecological procedures.
연구 개요
상세 설명
Endometrial sampling is a widely used gynecological procedure for the diagnosis and management of abnormal uterine bleeding and suspected endometrial pathology. The procedure may be performed under different anesthetic techniques, including sedo-analgesia and local anesthesia. Sedo-analgesia provides patient comfort through the administration of short-acting sedative and analgesic agents, whereas local anesthesia reduces procedural pain by blocking cervical nerve transmission. Both techniques are routinely used in clinical practice.
Sexual health is an important component of physical and psychological well-being. Procedure-related pain, anxiety, and postoperative discomfort may influence female sexual function and quality of life. However, limited data are available regarding the potential impact of anesthetic technique during endometrial sampling on subsequent sexual function.
The aim of this prospective observational cohort study is to evaluate whether undergoing endometrial sampling under sedo-analgesia or local anesthesia affects Female Sexual Function Index (FSFI) scores at one month after the procedure.
The study will be conducted at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital, between April 2026 and April 2027. A total of 210 women aged 18 to 60 years undergoing endometrial sampling will be enrolled. Participants will be allocated into two cohorts according to the anesthetic technique used during routine clinical care:
Sedo-analgesia group (n=105) Local anesthesia group (n=105) Female sexual function will be evaluated at the one-month follow-up visit using the validated Female Sexual Function Index (FSFI), a 19-item questionnaire assessing six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Demographic and clinical characteristics, including age, gravidity, parity, and abortion history, will also be recorded. FSFI scores will be compared between the two groups to determine whether anesthetic technique is associated with differences in postoperative sexual function.
Secondary analyses will include comparison of FSFI scores according to symptom status and histopathological diagnosis.
The results of this study may provide evidence regarding the influence of anesthetic management during gynecological procedures on female sexual health and may contribute to improving patient-centered perioperative care.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Yağmur ÖZKAN, M.D.
- 전화번호: +90 5374318241
- 이메일: yagmurolmez92@hotmail.com
연구 장소
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Istanbul, 터키 (Türkiye), 34384
- 모병
- Prof.Dr.Cemil Taşcıoğlu City Hospital
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연락하다:
- Yağmur ÖZKAN, M.D.
- 전화번호: +90 5374318241
- 이메일: yagmurolmez92@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Female patients aged 18 to 60 years
- Undergoing endometrial sampling at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital
- Undergoing the procedure under sedo-analgesia or local anesthesia as part of routine clinical practice
- Attendance at the 1-month follow-up visit
- Ability to complete the Female Sexual Function Index (FSFI) questionnaire
Exclusion Criteria:
- Age younger than 18 years or older than 60 years
- Presence of known chronic systemic disease
- Incomplete clinical or follow-up data
- Failure to attend the 1-month follow-up visit
- Inability or unwillingness to complete the FSFI questionnaire
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Sedo-Analgesia Group
Patients undergoing endometrial sampling under intravenous sedo-analgesia as part of routine clinical care.
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Local Anesthesia Group
Patients undergoing endometrial sampling under local anesthesia as part of routine clinical care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Female Sexual Function Index (FSFI) Score at 1 Month
기간: 1 Month After Endometrial Sampling
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Assessment of female sexual function one month after endometrial sampling using the validated Female Sexual Function Index (FSFI) questionnaire.
Total FSFI scores will be compared between patients undergoing endometrial sampling under sedo-analgesia and those undergoing the procedure under local anesthesia.
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1 Month After Endometrial Sampling
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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FSFI Subdomain Scores at 1 Month
기간: 1 Month After Endometrial Sampling
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Assessment of FSFI subdomain scores, including desire, arousal, lubrication, orgasm, satisfaction, and pain, one month after endometrial sampling.
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1 Month After Endometrial Sampling
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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FSFI Scores According to Histopathological Diagnosis
기간: 1 Month After Endometrial Sampling
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Comparison of total FSFI scores between patients with benign and malignant histopathological results after endometrial sampling.
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1 Month After Endometrial Sampling
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FSFI Scores According to Symptom Status
기간: 1 Month After Endometrial Sampling
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Comparison of total FSFI scores between symptomatic and asymptomatic patients undergoing endometrial sampling.
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1 Month After Endometrial Sampling
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTCH-FSFI-2026-001
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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