The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
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|ClinicalTrials.gov Identifier: NCT01289665|
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : July 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Examination, Gynecological Examination, Pelvic Examination, Vaginal||Procedure: Lubricating gel used during speculum insertion. Procedure: Water used during speculum examination.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
|Experimental: Lubricating Gel||
Procedure: Lubricating gel used during speculum insertion.
Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.
|Active Comparator: Water||
Procedure: Water used during speculum examination.
Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
- Patient discomfort during speculum insertion as measured by a visual analog scale. [ Time Frame: Immediate. ]The outcome measure is a single measurement of pain using a 10-point visual analog scale at the time of speculum insertion. There are no additional measurements and patients will not be followed for study purposes thereafter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289665
|United States, Florida|
|Department of Obstetrics and Gynecology, Florida Hospital|
|Orlando, Florida, United States, 32804|
|Study Chair:||David A Hill, MD||Florida Hospital|