Papanicolaou Smear Clinical Trial
Official title:
The EASE Trial: 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00520117 -
Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions
|