This trial is active, not recruiting.

Condition papanicolaou smear
Treatments no-stirrup vaginal examination, vaginal speculum examination done with stirrups.
Sponsor HamesNet Research Network
Collaborator Eisenhower Army Medical Center
Start date September 2008
End date January 2010
Trial size 1200 participants
Trial identifier NCT00755599, DDEAMC 07-15, JGAP G0806


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
(Active Comparator)
Vaginal speculum examinations done without stirrups.
no-stirrup vaginal examination
Vaginal speculum examination done with feet on table extender.
(Active Comparator)
Speculum examination with feet in stirrups.
vaginal speculum examination done with stirrups.
Speculum examination done with feet in stirrups.

Primary Outcomes

physical discomfort
time frame: post-procedure

Secondary Outcomes

Provider satisfaction
time frame: at the end of the study
sense of loss of control
time frame: post-procedure
sense of vulnerability
time frame: post-procedure

Eligibility Criteria

Female participants at least 18 years old.

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:

Additional Information

Official title The EASE Trial: Eisenhower's Alternative Speculum Examination
Principal investigator Dean A Seehusen, MD, MPH
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by Eisenhower Army Medical Center.