Eisenhower's Alternative Speculum Examination
Eisenhower's Alternative Speculum Examination
This study will determine patient and provider preferences regarding vaginal speculum
 examinations done with and without stirrups.

 Primary research hypothesis: Women undergoing speculum examination will experience at least
 20% less physical discomfort, 20% less sense of vulnerability, and 20% less sense of loss of
 control when using a no-stirrup method of examination compared to traditional in-stirrup
 examinations.

 Secondary research hypothesis: 25% or less of the providers taught this alternative method of
 speculum examination will find it to be unacceptable.
Subjects will be consented for inclusion into the study at the time of their presentation for
 one of the eligible presenting complaints. Those that agree to be part of the study will then
 be randomized to either stirrup or no-stirrup examinations. This will be done by opening
 previously sealed envelops with a data collection sheet inside of it. The sheet will say
 "stirrups" or "no-stirrups" at the top. This choice will be made via a random number table
 prior to beginning the study. The patient will then undergo examination using the indicated
 procedure. See Appendix A.

 All patients will undergo speculum examination with medium Graves speculum. Patients needing,
 or requesting, other size speculums will be removed from the study. The participating
 provider will fill out the top of the data collection sheets and the patient will be asked to
 fill out the bottom of the sheet after the provider leaves the room. The sheets will then be
 dropped off at the nurses' station or leave them in the examination room.

 Multiple aspects of physical discomfort, sense of control and sense of vulnerability will be
 assessed using a continuous scale. Patients will be asked to place a mark on a continuous
 line between two extremes. The distance will then be measured in millimeters in order to
 convert it to a numeric value. The measurement will be done by an independent provider in a
 blinded manner.

 Medical providers participating in the study will be consented for enrollment. They will be
 mailed consent forms and asked to sign them in front of a witness and mail the consent form
 back to the PI. They will be eligible as long as they believe they can enroll 25 patients
 over the course of approximately one year. Providers will be trained on how to perform a
 no-stirrup examination. The training will include standardized draping of patients as well as
 standardized positioning of patients in order to reduce the amount of variation introduced by
 the providers into these examinations. The training will include still images and an
 instructional video. The Principal Investigator will be available to anyone who has further
 questions regarding the technique. Participating providers will also be asked to perform at
 least 5 no-stirrup examinations on non-study subjects prior to beginning enrollment into the
 study to ensure familiarization with the technique. Providers will be recruited if they agree
 to attempt to enroll 25 or more patients to the study over the course of approximately one
 year. This will not be a difficult number to achieve for an active clinician.

 Providers who had not been trained on the no-stirrup speculum examination prior to the
 beginning this study will be sent a questionnaire querying them about their experience with
 the method after all data is collected.

 Protected Health Information will not be collect, so HIPAA forms will not be required.
Inclusion Criteria:

 -  Subjects must be 18 years of age or older and able to consent for themselves. All
 women undergoing speculum examinations for the following list of reasons will be
 eligible for this study. No other reasons for speculum examinations will be eligible.
 Eligible reasons:

 -  Pap smears during well woman examinations

 -  Pap smears during routine early pregnancy visit

 -  vaginal discharge

 -  vaginal bleeding

 -  sexually transmitted disease check

 Exclusion Criteria: