Pain
Conditions
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 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.
Interventions
DIAGNOSTIC_TESTExperimental 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.
Sponsors
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score: A change of 13mm | Within 1 hour of the exam | ale from 0-10, measured in mm. A change from baseline of 13mm is considered a significant change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing quality of life score: Range 0-4 | Within 1 hour of the exam | High wellbeing 2.504.0, Low Wellbeing 1.5-2.4, and very low wellbeing 0-1.4 |
| Rosenberg Self-esteem Score: Scale 10-40 | Within 1 hour of the exam | Higher numbers indicate higher self-esteem |
| Female Sexual Function Index-19 | Within 1 hour of the exam | Score of less than 26.55 indicates sexual dysfunction |
Countries
United States
Outcome results
None listed