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The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score: A change of 13mm | Within 1 hour of the exam |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 hour of the exam |
| Rosenberg Self-Esteem Score: Scale 10-40 | Higher numbers indicate higher self-esteem |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristene Whitmore, MD | Philadelphia Urosurgical Associates | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24112210 | Background | 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. | |
| 22825111 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Bimanual Exam | Other |
|
| Speculum Exam | Other |
|
| Within 1 hour of the exam |
| Female Sexual Function Index-19 | Score of less than 26.55 indicates sexual dysfunction | Within 1 hour of the exam |
| 12352766 | 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. |
| 6559035 | Result | Primrose RB. Taking the tension out of pelvic exams. Am J Nurs. 1984 Jan;84(1):72-4. No abstract available. |
| 21225474 | 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. |
| 14616277 | 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. |
| 9598951 | 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. |
| 8019173 | 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. |
| 8604867 | 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. |
| 11719741 | 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. |
| 15841702 | 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. |
| 10782451 | 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. |
| Result | Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press |
| 29474289 | Derived | 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. |