The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

Pain Clinical Trial

Official title:

The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393910
• Other study ID #: DrexelU
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pain

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 all — Click 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