Can We Improve the Comfort of Pelvic Exams?
April 3, 2017 updated by: Kristene Whitmore, Philadelphia Urosurgical Associates
The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual Analog Score: A change of 13mm
Time Frame: Within 1 hour of the exam
|
Within 1 hour of the exam
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Within 1 hour of the exam
|
|
Rosenberg Self-Esteem Score: Scale 10-40
Time Frame: Within 1 hour of the exam
|
Higher numbers indicate higher self-esteem
|
Within 1 hour of the exam
|
|
Female Sexual Function Index-19
Time Frame: Within 1 hour of the exam
|
Score of less than 26.55 indicates sexual dysfunction
|
Within 1 hour of the exam
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kristene Whitmore, MD, Philadelphia Urosurgical Associates
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Williams AA, Williams M. A guide to performing pelvic speculum exams: a patient-centered approach to reducing iatrogenic effects. Teach Learn Med. 2013;25(4):383-91. doi: 10.1080/10401334.2013.827969.
- Committee on Gynecologic Practice. Committee opinion No. 534: well-woman visit. Obstet Gynecol. 2012 Aug;120(2 Pt 1):421-4. doi: 10.1097/AOG.0b013e3182680517.
- Daley AM, Cromwell PF. How to perform a pelvic exam for the sexually active adolescent. Nurse Pract. 2002 Sep;27(9):28, 31-2, 34, 37-9, 43; quiz 44-5. doi: 10.1097/00006205-200209000-00006.
- Primrose RB. Taking the tension out of pelvic exams. Am J Nurs. 1984 Jan;84(1):72-4. No abstract available.
- Bates CK, Carroll N, Potter J. The challenging pelvic examination. J Gen Intern Med. 2011 Jun;26(6):651-7. doi: 10.1007/s11606-010-1610-8. Epub 2011 Jan 12.
- Hilden M, Sidenius K, Langhoff-Roos J, Wijma B, Schei B. Women's experiences of the gynecologic examination: factors associated with discomfort. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1030-6. doi: 10.1034/j.1600-0412.2003.00253.x.
- Wijma B, Gullberg M, Kjessler B. Attitudes towards pelvic examination in a random sample of Swedish women. Acta Obstet Gynecol Scand. 1998 Apr;77(4):422-8.
- Bernet R, Buddeberg C. [Physician-patient relations in gynecology: expectations and experiences of patients]. Gynakol Geburtshilfliche Rundsch. 1994;34(1):43-9. doi: 10.1159/000272333. German.
- Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
- Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
- Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206.
- Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press
- Rinko R, Yu I, Bakillah E, Alper L, Delaney C, Su M, Dawson M, Gracely EJ, Whitmore KE. Sequence of Pelvic Examination Affects Patient-Reported Pain. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):150-154. doi: 10.1097/SPV.0000000000000515.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2016
Primary Completion (Actual)
March 15, 2017
Study Completion (Actual)
March 30, 2017
Study Registration Dates
First Submitted
September 12, 2016
First Submitted That Met QC Criteria
September 21, 2016
First Posted (Estimate)
September 23, 2016
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Pelvic Exams
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.