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Eisenhower's Alternative Speculum Examination (EASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00755599
Recruitment Status : Unknown
Verified September 2008 by Eisenhower Army Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Papanicolaou Smear Procedure: no-stirrup vaginal examination Procedure: Vaginal speculum examination done with stirrups.

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: The EASE Trial: Eisenhower's Alternative Speculum Examination
Study Start Date : September 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Vaginal speculum examinations done without stirrups.
Procedure: no-stirrup vaginal examination
Vaginal speculum examination done with feet on table extender.
Active Comparator: 2
Speculum examination with feet in stirrups.
Procedure: Vaginal speculum examination done with stirrups.
Speculum examination done with feet in stirrups.


Outcome Measures

Primary Outcome Measures :
  1. physical discomfort [ Time Frame: post-procedure ]

Secondary Outcome Measures :
  1. Provider satisfaction [ Time Frame: at the end of the study ]
  2. sense of loss of control [ Time Frame: post-procedure ]
  3. sense of vulnerability [ Time Frame: post-procedure ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755599


Locations
United States, Georgia
Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30509
Sponsors and Collaborators
HamesNet Research Network
Eisenhower Army Medical Center
Pearl Network
Investigators
Principal Investigator: Dean A Seehusen, MD, MPH Eisenhower Army Medical Center
More Information

Responsible Party: Dean A. Seehusen, Eisenhower Army Medical Center
ClinicalTrials.gov Identifier: NCT00755599     History of Changes
Other Study ID Numbers: DDEAMC 07-15
JGAP G0806
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008

Keywords provided by Eisenhower Army Medical Center:
Papanicolaou Smear
Vaginitis
Patient Satisfaction