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NCT02913027 Clinical Trial

Can We Improve the Comfort of Pelvic Exams?

Pain Clinical Trial

Official title:
Can We Improve the Comfort of Pelvic Exams?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02913027
Other study ID # Pelvic Exams
Secondary ID
Status Completed
Phase N/A
First received September 12, 2016
Last updated April 3, 2017
Start date September 5, 2016
Est. completion date March 30, 2017

Study information
Verified date April 2017
Source Philadelphia Urosurgical Associates
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 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 30, 2017
Est. primary completion date March 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- English-speaking, female patients

- 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:

- Non-English speaking patients

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Philadelphia Urosurgical Associates

References & Publications (13)

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. Review. — View Citation

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

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. — 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

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

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

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( — View Citation

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

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 13 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 Within 1 hour of the exam
Secondary 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
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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