A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix
|ClinicalTrials.gov Identifier: NCT01670630|
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : March 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Comparison of a Sheathed Versus Standard Plastic Speculum||Procedure: Sheathed speculum examination Procedure: Standard speculum examination||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Active Comparator: Sheathed speculum
Investigators will perform a vaginal speculum examination with either a sheathed or a standard ("non sheathed" speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.
Procedure: Sheathed speculum examination
Active Comparator: Standard speculum examination
Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.
|Procedure: Standard speculum examination|
- Degree of cervix visualized. [ Time Frame: During vaginal speculum examination. ]To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.
- Comparison of pain during speculum examination. [ Time Frame: During speculum examination. ]To compare the subjects' comfort level between the sheathed and standard speculums when undergoing a vaginal speculum examination, using a patient-reported 10-cm visual analog scale (VAS).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670630
|United States, Florida|
|Loch Haven Ob/Gyn Group|
|Orlando, Florida, United States, 32804|
|Principal Investigator:||David A Hill, M.D.||Florida Hospital|