Can We Improve the Comfort of Pelvic Exams?

NCT02913027 | Completed

• 1 other identifier: Pelvic Exams
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score: A change of 13mm

  Within 1 hour of the exam

Secondary Outcomes (3)

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

  Within 1 hour of the exam

• Rosenberg Self-Esteem Score: Scale 10-40

  Within 1 hour of the exam

• Female Sexual Function Index-19

  Within 1 hour of the exam

Study Arms (2)

Observational

NO INTERVENTION

ARM: Normal Pelvic Exam Exposures: External Exam followed by speculum exam, followed by bimanual exam

Experimental Pelvic Exam

ACTIVE COMPARATOR

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

Other: External Exam; Other: Bimanual Exam; Other: Speculum Exam

Interventions

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.

Experimental Pelvic Exam

Bimanual Exam OTHER

Experimental Pelvic Exam

Speculum Exam OTHER

Experimental Pelvic Exam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philadelphia Urosurgical Associates: lead

Related Publications (14)

• 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.

  PMID: 24112210 BACKGROUND

• 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.

  PMID: 22825111 RESULT

• 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.

  PMID: 12352766 RESULT

• Primrose RB. Taking the tension out of pelvic exams. Am J Nurs. 1984 Jan;84(1):72-4. No abstract available.

  PMID: 6559035 RESULT

• 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.

  PMID: 21225474 RESULT

• 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.

  PMID: 14616277 RESULT

• 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.

  PMID: 9598951 RESULT

• 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.

  PMID: 8019173 RESULT

• 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.

  PMID: 8604867 RESULT

• 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.

  PMID: 11719741 RESULT

• 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.

  PMID: 15841702 RESULT

• 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.

  PMID: 10782451 RESULT

• Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press

  RESULT

• 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.

  PMID: 29474289 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristene Whitmore, MD

  Philadelphia Urosurgical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 23, 2016
• Study Start: September 5, 2016
• Primary Completion: March 15, 2017
• Study Completion: March 30, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04