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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Diagnostic test: Experimental 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 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel Ob/Gyn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational; Normal pelvic exam exposures: External exam followed by speculum exam, followed by bimanual exam
Active Comparator: Experimental Pelvic Exam; Changing the order of the pelvic exam Intervention: External exam, bimanual exam,speculum exam	Diagnostic test: Experimental Pelvic 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 xam, bimanual exam then speculum exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score: A change of 13mm	ale from 0-10, measured in mm. A change from baseline of 13mm is considered a significant change	Within 1 hour of the exam

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index-19	Score of less than 26.55 indicates sexual dysfunction	Within 1 hour of the exam
Wellbeing quality of life score: Range 0-4	High wellbeing 2.504.0, 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	Higher numbers indicate higher self-esteem	Within 1 hour of the exam

Collaborators and Investigators

• Sponsor: Drexel University

Publications and helpful links

General Publications

• 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.
• Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.
• 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.
• Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press.
• Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.
• 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.
• 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.
• Dargie EE, Chamberlain SM, Pukall CF. Provoked Vestibulodynia: Diagnosis, Self-Reported Pain, and Presentation During Gynaecological Examinations. J Obstet Gynaecol Can. 2017 Mar;39(3):145-151. doi: 10.1016/j.jogc.2017.01.001.
• Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.
• Goetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-1236. doi: 10.1097/AOG.0000000000000283.
• 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.
• 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.
• Nyirjesy P, Peyton C, Weitz MV, Mathew L, Culhane JF. Causes of chronic vaginitis: analysis of a prospective database of affected women. Obstet Gynecol. 2006 Nov;108(5):1185-91. doi: 10.1097/01.AOG.0000239103.67452.1a.
• Rinko R, Spector C, Cook E, Mancenido B, Gracely EJ, Nyirjesy P. Sequence of Pelvic Examination Does Not Affect Patients With Baseline Vulvovaginal Syndromes: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e45-e51. doi: 10.1097/SPV.0000000000000791.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): July 16, 2018
• Study Completion (Actual): July 16, 2018

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: DrexelU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No