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OpenTrials
Completed

NCT Number: NCT02913027

Can We Improve the Comfort of Pelvic Exams?

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

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 the self-reported comfort during each section of the pelvic exam and how comfort during the exam relates to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age in an outpatient setting.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English-speaking, female patients
  • Are able to can read and write English
  • Are utilizing outpatient services at an OBGYN outpatient office
  • Are scheduled for a well-woman exam

Exclusion criteria

  • Non-English speaking patients
  • Patients who cannot read or write
  • Those who are pregnant
  • Have an active vaginal infection
  • Patients who, otherwise, do not require a speculum exam during their appointment

Treatment and study plan

External Exam

Other

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 exam, bimanual exam, then speculum exam.

Bimanual Exam

Other

Speculum Exam

Other

Primary outcomes

  1. Visual Analog Score: A change of 13mm

    Time frame: Within 1 hour of the exam

Secondary outcomes

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

    Time frame: Within 1 hour of the exam

    High wellbeing 2.5-4.0, 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

Philadelphia Urosurgical Associates

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 23, 2016
Registry last updated
Apr 4, 2017

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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