Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 主要终点
- assesment of pain immediately at the end of the procedure and 15 minutes after it
研究概览
简要总结
The aim of the study is to compare the effectiveness of warm saline distension media versus room temperature saline distension media on relieving pain in office hysteroscopy .
详细描述
Research hypothesis :
In women undergoing diagnostic hysteroscopy, warm saline distension media may be effective in decreasing the pain during the procedure .
Research question :
In women undergoing diagnostic hysteroscopy, does warm saline distension media decrease the pain during the procedure ?
Aim of the work :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 20-40 years old (premenopausal women ).
- •Normal cervical morphology during speculum examination.
- •Women complaining of abnormal uterine bleeding
- •Women underging the procedure to evaluate the endocervical canal, uterine cavity and tubal ostia because of infertility.
- •Suspected mullerian anomalies.
排除标准
- •a. Pregnancy. b. Suspected acute pelvic inflammatory disease. c. Past history of medical disorders, especially associated with neuropathies, e.g. diabetes, chronic kidney disease, etc.
- •d. History of vaginal pruritis, discharge, dysuria, dysmenorrhea, dyspareunia or chronic pelvic pain.
- •e. Presence of pain, profuse bleeding or other symptoms at the time of the procedure.
- •f. History of uterine surgery that occurred less than 1 month previously. g. History of previous cervical procedures. h. Administration of general, cervical or paracervical anesthesia. i. Administration of sedatives. j. Any use of analgesic agents before the procedure. k. Cervical preparation by misoprostol before procedure orally or vaginally for cervical ripening to improve the likelihood of successful cervical dilation and decrease intraoperative pain .
- •l. Need for cervical dilatation during procedure. m. Need for biopsy or any operative intervention during the procedure.
结局指标
主要结局
assesment of pain immediately at the end of the procedure and 15 minutes after it
时间窗: immediately after the procedure and 15 minutes after the end of it
d. The degree of pain that the patient feels in the procedure will be estimated by using visual analoge scale (VAS) (figure 1) at 2 times: At the end of the procedure and at 15 minutes after the examination. The patient makes a mark on the VAS line to indicate the intensity of her pain. The distance from the zero point to the marked point is measured using a graduated ruler. Each pain assessment is made on a separate line.
次要结局
- patient satisfaction(during procedure)
- time taken to complete the procedure(during procedure)
研究者
Melad Eskander
Sohag
Ain Shams University