The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

Drexel University200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Pain

Interventions

Experimental Pelvic ExamDIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Drexel Ob/Gyn

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: Within 1 hour of the exam

Secondary Outcomes

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

Time frame: Within 1 hour of the exam

Rosenberg Self-esteem Score: Scale 10-40

Higher numbers indicate higher self-esteem

Time frame: Within 1 hour of the exam

Female Sexual Function Index-19

Score of less than 26.55 indicates sexual dysfunction

Time frame: Within 1 hour of the exam

Data from ClinicalTrials.gov

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