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No Stirrups for Pap Smear (EASE Trial)
N/A
Waitlist Available
Led By Dean A Seehusen, MD, MPH
Research Sponsored by HamesNet Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post-procedure
Awards & highlights
No Placebo-Only Group
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
physical discomfort
Secondary study objectives
sense of loss of control
sense of vulnerability
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: No StirrupsActive Control1 Intervention
Vaginal speculum examinations done without stirrups. The woman's feet will be placed onto the exam table allowing maximal repositioning by the woman.
Group II: StirrupsActive Control1 Intervention
Speculum examination with feet in stirrups. The woman's feet will be placed into obstetric stirrups which fix the feet in place.
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Who is running the clinical trial?
HamesNet Research NetworkLead Sponsor
Eisenhower Army Medical CenterLead Sponsor
8 Previous Clinical Trials
723 Total Patients Enrolled
Pearl NetworkNETWORK
5 Previous Clinical Trials
3,560 Total Patients Enrolled
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