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

Study Overview
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Brief Summary
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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
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The outcome measure is patient discomfort as measured by a visual analogue scale.

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

Conditions
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Examination, Gynecological, Examination, Pelvic, Examination, Vaginal

Intervention / Treatment
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* Procedure: Lubricating gel used during speculum insertion.
* Procedure: Water used during speculum examination.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricating Gel<br> | Procedure: Lubricating gel used during speculum insertion.<br>* 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.<br>|
| Active Comparator: Water<br> | Procedure: Water used during speculum examination.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale. | 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. | Immediate. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gel, lubricating, speculum, Pain, Pelvic, Examination, Gynecological