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 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.
Interventions
OTHERExternal 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.
OTHERBimanual Exam
OTHERSpeculum Exam
Sponsors
Philadelphia Urosurgical Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Score: A change of 13mm | Within 1 hour of the exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing quality of life score: Range 0-4. | Within 1 hour of the exam | High wellbeing 2.5-4.0, 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 |
Outcome results
None listed