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CompletedNCT02913027Updated Apr 4, 2017

Can We Improve the Comfort of Pelvic Exams?

An interventional study of External Exam and Bimanual Exam in Pain, sponsored by Philadelphia Urosurgical Associates. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Philadelphia Urosurgical Associates · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the 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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Conditions studied

  • Pain
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In context

Lead sponsor

Philadelphia Urosurgical Associates is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • 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 · Other: Bimanual Exam · Other: Speculum Exam

Interventions

  • OtherExternal 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.

  • OtherBimanual Exam
  • OtherSpeculum Exam
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What researchers measure

Primary outcomes

  1. Visual Analog Score: A change of 13mm

    Time frame: Within 1 hour of the exam

Secondary outcomes

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

    High wellbeing 2.5-4.0, Low wellbeing 1.5-2.4, and very low wellbeing 0-1.4

    Time frame: Within 1 hour of the exam

  2. Rosenberg Self-Esteem Score: Scale 10-40

    Higher numbers indicate higher self-esteem

    Time frame: Within 1 hour of the exam

  3. Female Sexual Function Index-19

    Score of less than 26.55 indicates sexual dysfunction

    Time frame: Within 1 hour of the exam

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 24112210 ↗
  • 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. PubMed 22825111 ↗
  • 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. PubMed 12352766 ↗
  • Primrose RB. Taking the tension out of pelvic exams. Am J Nurs. 1984 Jan;84(1):72-4. No abstract available. PubMed 6559035 ↗
  • 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. PubMed 21225474 ↗
  • 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. PubMed 14616277 ↗
  • 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. PubMed 9598951 ↗
  • 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. PubMed 8019173 ↗
  • 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. PubMed 8604867 ↗
  • 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. PubMed 11719741 ↗
  • 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. PubMed 15841702 ↗
  • 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. PubMed 10782451 ↗
  • 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. PubMed 29474289 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02913027
Lead sponsor
Philadelphia Urosurgical Associates
Responsible party
Kristene Whitmore (Physician, Philadelphia Urosurgical Associates) — Principal investigator
First posted
Sep 23, 2016
Start date
Sep 5, 2016
Primary completion
Mar 15, 2017
Completion
Mar 30, 2017
Last update
Apr 4, 2017

Study contacts

Kristene Whitmore, MD
principal investigator · Philadelphia Urosurgical Associates

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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