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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 620
- Locations
- 1
- Primary Endpoint
- Percentage of cervix visualized - subjectively and objectively.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •all women of age more than or equal to 18 years, coming to Gynecology OPD in JIPMER.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Percentage of cervix visualized - subjectively and objectively.
Time Frame: 18 MONTHS
discomfort experienced by the patient during examination using a 5point visual analog scale
Time Frame: 18 MONTHS
Secondary Outcomes
- 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.)
Investigators
Dr Rinisha V P
JIPMER