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Completed

NCT Number: NCT03393910

The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Drexel Ob/Gyn

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Pelvic Exam

Diagnostic 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.

Primary outcomes

  1. Visual Analog Score: A change of 13mm

    Time frame: 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 outcomes

  1. Wellbeing quality of life score: Range 0-4

    Time frame: Within 1 hour of the exam

    High wellbeing 2.504.0, Low Wellbeing 1.5-2.4, and very low wellbeing 0-1.4

  2. Rosenberg Self-esteem Score: Scale 10-40

    Time frame: Within 1 hour of the exam

    Higher numbers indicate higher self-esteem

  3. Female Sexual Function Index-19

    Time frame: Within 1 hour of the exam

    Score of less than 26.55 indicates sexual dysfunction

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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