Warm Versus Room Temperature Saline as a Uterine Distension Medium for Pain Reduction in Women Undergoing Outpatient Hysteroscopy: Protocol for a Randomized Controlled Trial
연구 개요
상태
상세 설명
Outpatient diagnostic hysteroscopy is commonly performed for the evaluation of intrauterine abnormalities and other gynecological indications. Pain during hysteroscopy may be influenced by cervical manipulation, uterine distension, and uterine contractions. The temperature of the distension medium may influence patient discomfort during the procedure.
This study is a parallel-group superiority randomized controlled trial designed to compare warmed normal saline at 37°C with room-temperature normal saline as the uterine distension medium during outpatient diagnostic hysteroscopy.
Eligible participants will be women aged 18 to 70 years who are scheduled for outpatient diagnostic hysteroscopy and who are able to understand and report pain using a visual analog scale. Participants will provide written informed consent before enrollment.
A total of 60 participants will be randomized in a 1:1 ratio to one of two study groups. The intervention group will undergo hysteroscopy using normal saline warmed to 37°C. The comparison group will undergo hysteroscopy using normal saline at room temperature. The temperature of the saline will be monitored using an infrared thermometer.
Pain intensity during the hysteroscopy will be assessed using a 0-to-10 visual analog scale and will constitute the primary outcome of the study. Secondary outcomes will include pain intensity one hour after the procedure, the need for additional analgesia during or after the procedure, and the proportion of participants in whom the procedure is abandoned because of intolerable pain.
The study will be conducted in the outpatient Endoscopy Unit of Demerdash Maternity Hospital, Ain Shams University. Diagnostic hysteroscopy will be performed using a 5-mm Karl Storz hysteroscope by the same senior physician.
The study is designed to determine whether the use of warmed saline at 37°C provides a clinically meaningful reduction in pain compared with room-temperature saline during outpatient diagnostic hysteroscopy.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Reem M Sadiq, MBBCh
- 전화번호: +201113939778
- 이메일: reem_mohamed@med.asu.edu.eg
연구 장소
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Cairo, 이집트
- Ain Shams University Maternity Hospital
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연락하다:
- Reem M Sadiq, MBBCh
- 전화번호: +201113939778
- 이메일: reem_mohamed@med.asu.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18-70 years.
- Ability to understand and report pain using the Visual Analog Scale.
- Willingness to undergo outpatient hysteroscopy and provide written informed consent.
Exclusion Criteria:
- Congenital genital tract malformations: including these patients could introduce a confounding factor because pain may result from difficult anatomy rather than the temperature of the distension medium.
- Previous hysteroscopic procedures: pain perception may be influenced by prior experience rather than the intervention itself
- Suspected pregnancy: standard gynecologic practice considers pregnancy a contraindication to elective diagnostic hysteroscopy
- Active pelvic infection: instrumentation of an infected genital tract may increase morbidity and facilitate ascending infection. Also, pain scores may reflect infection-related pain rather than procedural pain.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Warmed saline at 37 degrees celsius
Participants randomized to this arm will undergo outpatient diagnostic hysteroscopy using normal saline warmed to 37°C as the uterine distension medium.
The planned allocation is 30 participants.
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Normal saline warmed to 37°C and used as the uterine distension medium during outpatient diagnostic hysteroscopy.
The temperature of the saline will be monitored using an infrared thermometer before and during the procedure.
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활성 비교기: Room-Temperature Saline
Participants randomized to this arm will undergo outpatient diagnostic hysteroscopy using normal saline at room temperature as the uterine distension medium.
The planned allocation is 30 participants.
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Normal saline at room temperature used as the uterine distension medium during outpatient diagnostic hysteroscopy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain intensity during outpatient diagnostic hysteroscopy measured using the Visual Analog Scale (VAS)
기간: During the hysteroscopy procedure
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Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable.
The VAS score recorded immediately after the hysteroscopy will be compared between participants receiving warmed normal saline at 37°C and those receiving room-temperature normal saline.
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During the hysteroscopy procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain intensity one hour after outpatient diagnostic hysteroscopy measured using the Visual Analog Scale (VAS)
기간: 1 hour after completion of the hysteroscopy
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Pain intensity will be assessed one hour after completion of the hysteroscopy using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable.
VAS pain scores will be compared between participants receiving warmed normal saline at 37°C and those receiving room-temperature normal saline.
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1 hour after completion of the hysteroscopy
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Need for additional analgesia after outpatient diagnostic hysteroscopy
기간: 1 hour after completion of the procedure
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The need for additional analgesia will be recorded as a binary outcome according to whether the participant requires analgesic medication.
The proportion of participants requiring additional analgesia will be compared between the warmed saline at 37°C group and the room-temperature saline group.
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1 hour after completion of the procedure
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Proportion of procedures abandoned due to intolerable pain
기간: During the hysteroscopy procedure
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The proportion of participants in whom outpatient diagnostic hysteroscopy is abandoned because of intolerable pain will be recorded and compared between the warmed saline at 37°C group and the room-temperature saline group.
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During the hysteroscopy procedure
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Tawfek ME, Hemeda HM, Ibrahim MA. Effectiveness of warm saline distension media on relieving pain in outpatient office hysteroscopy: a randomized controlled clinical trial. Journal of Gynecology & Reproductive Medicine. 2019;3(1):1-7.
- De Silva PM, Smith PP, Cooper NAM, Clark TJ; Royal College of Obstetricians and Gynaecologists. Outpatient Hysteroscopy: (Green-top Guideline no. 59). BJOG. 2024 Dec;131(13):e86-e110. doi: 10.1111/1471-0528.17907. Epub 2024 Aug 19.
- Kapur S, Gruber A, Sekar H, Mafuta J, Lodhi W, Sivashanmugarajan V, Yoong W. Does temperature of distending medium matter in outpatient hysteroscopy? A double-blinded cohort control observational study of room temperature versus warmed saline. J Obstet Gynaecol Res. 2020 Mar;46(3):485-489. doi: 10.1111/jog.14207. Epub 2020 Jan 28.
- Issat T, Beta J, Nowicka MA, Durczynski A, Jakimiuk AJ. Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Clin Exp Obstet Gynecol. 2017;44(3):359-363.
- Evangelista A, Oliveira MA, Crispi CP, Lamblet MF, Raymundo TS, Santos LC. Diagnostic hysteroscopy using liquid distention medium: comparison of pain with warmed saline solution vs room-temperature saline solution. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):104-7. doi: 10.1016/j.jmig.2010.09.009.
- Nair VG, Mahajan R, Aziz A, Tiwari S. Effectiveness of warm saline for pain relief in office hysteroscopy: a prospective randomized control trial. International Journal of Clinical Obstetrics and Gynaecology. 2020;4(4):85-88. DOI: 10.33545/gynae.2020.v4.i4b.628.
- Baradwan S, Khalil M, Alshahrani MS, Albouq B, AlSghan R, Khadawardi K, Mohamed DF, Yousef DH, Kamal SHM, Abdel Halim HW, Elhawary MAA, Alkholy EA, Elsharkawy MRM, Abdelhakim AM, Abbas AM, Dahshan SA, Alshawadfy A, Soror GI. Warm saline effectiveness for pain relief in office hysteroscopy: A systematic review and meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2022 Jul;48(7):1523-1530. doi: 10.1111/jog.15272. Epub 2022 Apr 24.
- Abdallah KS, Gadalla MA, Breijer M, Mol BWJ. Uterine distension media for outpatient hysteroscopy. Cochrane Database Syst Rev. 2021 Nov 26;11(11):CD006604. doi: 10.1002/14651858.CD006604.pub2.
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
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QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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키워드
기타 연구 ID 번호
- FMASU MS 555/ 2026
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