Comparison of Lidocaine Spray With Forced Coughing in Pain Relief During Colposcopy Guided Cervical Biopsy Procedure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system
研究概览
简要总结
Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. The colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. Local anesthetic agent injection into the cervix has been studied and found to be effective and also, forced coughing was compared with local anesthetic injection and it is found to be more effective. In fact local injections can create the pain by itself.However no study compared the effect of forced coughing to local anesthetic spray. The study aims to evaluate the comparison of forced coughing with local anesthetic spray with respect to perceived pain during colposcopy guided biopsy.
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)
盲法说明
The participants will be blinded to the methods used for pain relief.
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
- •Patients with age >18,
- •Presence of cervix,
- •Patients who need a diagnostic work up for abnormal cervical smear results.
排除标准
- •Pregnancy,
- •Presence of already known invasive cancer,
- •Allergy to anesthetic agents.
研究组 & 干预措施
colposcopic biopsy under local anesthetic sp
干预措施: local lidocaine spray (Drug)
Patients underwent colposcopic biopsy under forced coughing
干预措施: forced coughing (Other)
结局指标
主要结局
Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system
时间窗: 0-1 min
The perceived pain will be measured during the biopsy procedure. It will be evaluated by the 0-10 cm scale of VAS scoring system. The patient will be asked to rate her pain as 0 corresponds ''no pain'' and 10 to the '' worst pain''
次要结局
- Pain at the 30th minutes after the procedure evaluated by the 0-10 cm scale of VAS scoring system(30. Min)
研究者
erbil karaman
Assistant Professor
Yuzuncu Yıl University