Eisenhower's Alternative Speculum Examination

NCT00755599 | Withdrawn

• 1 other identifier: DDEAMC 07-15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Papanicolaou Smear

Keywords

Papanicolaou Smear; Vaginitis; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• physical discomfort

  As measured by a visual analog scale immediately after the procedure.

  Immediately post-procedure

Secondary Outcomes (2)

• sense of loss of control

  Immediately post-procedure

• sense of vulnerability

  Immediately post-procedure

Study Arms (2)

No Stirrups

ACTIVE COMPARATOR

Vaginal speculum examinations done without stirrups. The woman's feet will be placed onto the exam table allowing maximal repositioning by the woman.

Procedure: no-stirrup vaginal examination

Stirrups

ACTIVE COMPARATOR

Speculum examination with feet in stirrups. The woman's feet will be placed into obstetric stirrups which fix the feet in place.

Procedure: Vaginal speculum examination done with stirrups.

Interventions

no-stirrup vaginal examination PROCEDURE

Vaginal speculum examination done with feet on table extender.

No Stirrups

Vaginal speculum examination done with stirrups. PROCEDURE

Speculum examination done with feet in stirrups.

Stirrups

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Eisenhower Army Medical Center: lead
• Pearl Network: collaborator

Study Sites (1)

Eisenhower Army Medical Center

Fort Gordon, Georgia, 30509, United States

Location

MeSH Terms

Conditions

Vaginitis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dean A Seehusen, MD, MPH

  Eisenhower Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomization into one of two arms

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (1)