The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

Not Applicable

Completed

• Conditions: Pain
• Interventions: Diagnostic Test: Experimental Pelvic Exam

• Registration Number: NCT03393910
• Lead Sponsor: Drexel University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Study Start: 2018-01-22
• Status Verified: 2018-07
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Pelvic Exam	Experimental Pelvic Exam	Changing the order of the pelvic exam Intervention: External exam, bimanual exam,speculum exam

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Drexel Ob/Gyn; 🇺🇸 Philadelphia, Pennsylvania, United States