Percentage of cervix visualized and patient’s discomfort with Bouquet speculum in comparison with Cusco’s speculum during evaluation of uterine cervix in women attending Gynecology OPD - A stratified randomized control trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Percentage of cervix visualized - subjectively and objectively.
研究概览
简要总结
This study is a stratified randomized control trial comparing the Percentage of cervix visualized and patient’s discomfort with Bouquet speculum and Cusco’s speculum during evaluation of uterine cervix in women attending Gynecology OPD.
the primary outcome measures will be To compare the percentage of cervix visualized with Bouquet speculum in comparison with Cusco’s speculum
and To assess the discomfort level experienced by the patient with Bouquet speculum in comparison to Cusco’s speculum on a 5 point visual analogue scale.
the secondary outcome will be the Quantitative assessment of the ease of use of Bouquet speculum in comparison to Cusco’s speculum on a 5point Likert scale and also qualitative assessment of the same atthe end of the study.
my hypothesis is that Bouquet speculum is likely to be better in regard to both visualization of cervix and patient comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •all women of age more than or equal to 18 years, coming to Gynecology OPD in JIPMER.
排除标准
- •Virgin women women with cervical, vaginal or vulval growth completely obliterating the visualization of cervix.
- •women with stenosed vagina post radiation therapy for any malignancy Women with UV prolapse women who underwent total hysterectomy.
结局指标
主要结局
Percentage of cervix visualized - subjectively and objectively.
时间窗: 18 MONTHS
discomfort experienced by the patient during examination using a 5point visual analog scale
时间窗: 18 MONTHS
次要结局
- Ease of use of speculums by the physician on a likert scale of 5.(Qualitative in depth interview with the clinician at the end of the study.)
研究者
Dr Rinisha V P
JIPMER