Can We Improve the Comfort of Pelvic Exams?

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: External Exam; Other: Bimanual Exam; Other: Speculum Exam

• Registration Number: NCT02913027
• Lead Sponsor: Philadelphia Urosurgical Associates

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 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.

Study Timeline

• Study Start: 2016-09-05
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Primary Completion: 2017-03-15
• Study Completion: 2017-03-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Pelvic Exam	Speculum Exam	Arm: Changing the order of Pelvic Exam Intervention: External exam, Bimanual Exam, Speculum Exam
Experimental Pelvic Exam	Bimanual Exam	Arm: Changing the order of Pelvic Exam Intervention: External exam, Bimanual Exam, Speculum Exam
Experimental Pelvic Exam	External Exam	Arm: Changing the order of 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

Secondary Outcome Measures

Name	Time	Method
Wellbeing quality of life score: Range 0-4.	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
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