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Can We Improve the Comfort of Pelvic Exams?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913027
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Kristene Whitmore, 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.

Condition or disease Intervention/treatment Phase
Pain Other: External Exam Other: Bimanual Exam Other: Speculum Exam Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can We Improve the Comfort of Pelvic Exams?
Actual Study Start Date : September 5, 2016
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : March 30, 2017

Arm Intervention/treatment
No Intervention: Observational
ARM: Normal Pelvic Exam Exposures: External Exam followed by speculum exam, followed by bimanual exam
Active Comparator: Experimental Pelvic Exam
Arm: Changing the order of Pelvic Exam Intervention: External exam, Bimanual Exam, Speculum Exam
Other: External Exam
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.

Other: Bimanual Exam
Other: Speculum Exam



Primary Outcome Measures :
  1. Visual Analog Score: A change of 13mm [ Time Frame: Within 1 hour of the exam ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913027


Sponsors and Collaborators
Philadelphia Urosurgical Associates
Investigators
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Principal Investigator: Kristene Whitmore, MD Philadelphia Urosurgical Associates
Publications of Results:
Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristene Whitmore, Physician, Philadelphia Urosurgical Associates
ClinicalTrials.gov Identifier: NCT02913027    
Other Study ID Numbers: Pelvic Exams
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided