Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2016-09-05
2017-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Observational
ARM: Normal Pelvic Exam Exposures: External Exam followed by speculum exam, followed by bimanual exam
No interventions assigned to this group
Experimental Pelvic Exam
Arm: Changing the order of Pelvic Exam Intervention: External exam, Bimanual Exam, Speculum Exam
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.
Bimanual Exam
Speculum Exam
Interventions
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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.
Bimanual Exam
Speculum Exam
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Philadelphia Urosurgical Associates
OTHER
Responsible Party
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Kristene Whitmore
Physician
Principal Investigators
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Kristene Whitmore, MD
Role: PRINCIPAL_INVESTIGATOR
Philadelphia Urosurgical Associates
References
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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.
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.
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.
Other Identifiers
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Pelvic Exams
Identifier Type: -
Identifier Source: org_study_id
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