The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

Study Overview
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Brief Summary
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The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

Detailed Description
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The purpose of this randomized controlled trial is to investigate the sequence in which physicians perform the pelvic exam, describe and compare self-reported comfort during each section of the pelvic exam and how comfort during the examinations related to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age with chronic vulvovaginal conditions.

Official Title
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The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

Conditions
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Pain

Intervention / Treatment
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* Diagnostic Test: Experimental Pelvic Exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English Speaking Are able to read and write English Are utilizing outpatient services and being seen for a first appointment at an outpatient Vulvodynia Center Exclusion Criteria: Non English Speaking Patients who cannot read or write Those who are pregnant Those who do not have a chronic vulvovaginal condition Patients other than new patients Patients who would not otherwise need a speculum exam

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observational<br>Normal pelvic exam exposures: External exam followed by speculum exam, followed by bimanual exam | |
| Active Comparator: Experimental Pelvic Exam<br>Changing the order of the pelvic exam Intervention: External exam, bimanual exam,speculum exam | Diagnostic Test: Experimental Pelvic Exam<br>* The pelvic exam will be completed in the following order: external, speculum, bimanual exam in the standard group. In the Experimental group the pelvic exam will be done with external xam, bimanual exam then speculum exam.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score: A change of 13mm | ale from 0-10, measured in mm. A change from baseline of 13mm is considered a significant change | Within 1 hour of the exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing quality of life score: Range 0-4 | High wellbeing 2.504.0, Low Wellbeing 1.5-2.4, and very low wellbeing 0-1.4 | Within 1 hour of the exam | 
| Rosenberg Self-esteem Score: Scale 10-40 | Higher numbers indicate higher self-esteem | Within 1 hour of the exam | 
| Female Sexual Function Index-19 | Score of less than 26.55 indicates sexual dysfunction | Within 1 hour of the exam |