The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.

Not Applicable

Completed

• Conditions: Examination, Gynecological; Examination, Pelvic; Examination, Vaginal
• Interventions: Procedure: Water used during speculum examination.; Procedure: Lubricating gel used during speculum insertion.

• Registration Number: NCT01289665
• Lead Sponsor: AdventHealth

Brief Summary

The purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.

Detailed Description

The outcome measure is patient discomfort as measured by a visual analogue scale.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2020-10-15
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Results First Posted: 2020-11-17
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Women undergoing vaginal speculum examination between the ages of 18 and 50.

Exclusion Criteria

• Pregnancy.
• Non-English speaking.
• Using hormone therapy.
• Active vulvar or vaginal lesion, infection or complaint.
• Undergoing vaginal or vulvar procedure or biopsy.
• History of chronic pelvic pain, interstitial cystitis or vulvar vestibulitis.
• History of prior vulvar or vaginal surgical procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water	Water used during speculum examination.	-
Lubricating Gel	Lubricating gel used during speculum insertion.	-

Primary Outcome Measures

Name	Time	Method
Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.	Immediate.	The outcome measure is a single measurement of pain using a 10-point visual analog scale entitled "Visual Pain Scale" immediately following speculum insertion. The scale is a continuous 10cm line with the minimum value of 0 (labeled "no pain") on the left side of the line, and a maximum value of 10 (labeled "worst pain") on the right side of the line. Higher scores represent more pain and a worse outcome. There are no additional measurements obtained, and patients will not be followed for study purposes thereafter.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Florida Hospital; 🇺🇸 Orlando, Florida, United States