A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Patients' Biopsy Sizes
研究概览
简要总结
The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.
详细描述
The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-80 year-old women who had colposcopic biopsy
排除标准
- •Had orthopedical problems
- •Analgesic allergy
- •Have previous cone biopsy
- •Analgesic use until six hours before colposcopy
- •Advanced cervicovaginal atrophy
- •Linear Visual Analog Score for pain is used
研究组 & 干预措施
tenaculum with intracervical blockage
干预措施: Tenaculum replacement (Other)
No tenaculum with intracercical blockage
Tenaculum without intracervical blockage
干预措施: Tenaculum replacement (Other)
No Tenaculum without intracervical blockage
结局指标
主要结局
Patients' Biopsy Sizes
时间窗: 6 months
Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.
次要结局
- Patients' pain perceptions(6 months)