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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | No Intervention | Normal pelvic exam exposures: External exam followed by speculum exam, followed by bimanual exam | |
| Experimental Pelvic Exam | Active Comparator | Changing the order of the pelvic exam Intervention: External exam, bimanual exam,speculum exam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Pelvic Exam | Diagnostic Test | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel Ob/Gyn | Philadelphia | Pennsylvania | 19102 | United States |
| 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. | |
| 14616277 | Background | 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. |
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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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| 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 |
| 9598951 | Background | 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 | Background | 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. |
| 12352766 | Background | 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 | Background | Primrose RB. Taking the tension out of pelvic exams. Am J Nurs. 1984 Jan;84(1):72-4. No abstract available. |
| 17077241 | Background | 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. |
| 24807329 | Background | 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. |
| 28343555 | Background | 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. |
| 11354213 | Background | 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. |
| 9835471 | Background | 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. |
| 11690725 | Background | 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. |
| 8604867 | Background | 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 | Background | 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. |
| Background | Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press. |
| 15841702 | Background | 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 | Background | 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. |
| 32332423 | Derived | 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. |