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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03393910
Other study ID # DrexelU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2018
Est. completion date July 16, 2018

Study information

Verified date July 2018
Source Drexel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 16, 2018
Est. primary completion date July 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- English Speaking Are able to read and write English Are utilizing outpatient services and being seen for a first appointment at an outpatient Vulvodynia Center

Exclusion Criteria:

- Non English Speaking

- Patients who cannot read or write

- Those who are pregnant

- Those who do not have a chronic vulvovaginal condition

- Patients other than "new" patients

- Patients who would not otherwise need a speculum exam

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Experimental Pelvic 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 xam, bimanual exam then speculum exam.

Locations

Country Name City State
United States Drexel Ob/Gyn Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

References & Publications (17)

Bernet R, Buddeberg C. [Physician-patient relations in gynecology: expectations and experiences of patients]. Gynakol Geburtshilfliche Rundsch. 1994;34(1):43-9. German. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Goetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-6. doi: 10.1097/AOG.0000000000000283. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Primrose RB. Taking the tension out of pelvic exams. Am J Nurs. 1984 Jan;84(1):72-4. — View Citation

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. — View Citation

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

Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-2. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Rosenberg Self-esteem Score: Scale 10-40 Higher numbers indicate higher self-esteem Within 1 hour of the exam
Secondary Female Sexual Function Index-19 Score of less than 26.55 indicates sexual dysfunction Within 1 hour of the exam
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