Clinical trial NCT02913027: Can We Improve the Comfort of Pelvic Exams?
Official title: Can We Improve the Comfort of Pelvic Exams?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Philadelphia Urosurgical Associates
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Score: A change of 13mm
timeFrame: Within 1 hour of the exam
Secondary outcomes:
measure: Wellbeing quality of life score: Range 0-4.
timeFrame: Within 1 hour of the exam
measure: Rosenberg Self-Esteem Score: Scale 10-40
timeFrame: Within 1 hour of the exam
measure: Female Sexual Function Index-19
timeFrame: Within 1 hour of the exam
Other outcomes:
Locations:
Study officials:
affiliation: Philadelphia Urosurgical Associates
name: Kristene Whitmore, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1080/00926230590475206.
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. doi: 10.1080/009262300278597.
citation: Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press
citation: 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.