A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort

NCT01788124 | Completed

• 1 other identifier: macomb0001
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the comfort of two type of speculums used during routine gynecologic exam. Your treatment and medical care will not change because you are participating in this study. Your doctor will continue to make all decisions regarding your proper treatment and care.

Conditions

Patient Comfort

Keywords

Speculum; Metal; Plastic; Visual Analoge Scale; Discomfort

Outcome Measures

Primary Outcomes (1)

• Patient Discomfort VAS

  . Patients presenting for routine gynecological examination will be randomized to either plastic or metal speculum arm. Patient discomfort will be assessed using a self administered visual analogue scale (VAS). Patient comfort between groups will be assessed

  up to one day post exam

Study Arms (2)

Metal Speculum

exam with metal speculum

Plastic Speculum

exam with plastic speculum

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women greater than 18 years of age presenting for routine speculum exam

You may qualify if:

• Any woman presenting to Great Lakes Obstetrics and Gynecology or Macomb Academic OB/GYN Clinic for a routine gynecological exam
• Women ≥ 18 years of age
• Women willing and able to give informed consent according to the guidelines established by the St John IRB

You may not qualify if:

• Patients that can not or will not sign the informed consent document
• Women whose English language skills are insufficient to understand the written informed consent or the post examination questionnaire.
• Any woman for who use of a speculum is contraindicated.
• Any woman with a condition that might alter pain perception
• Current pain medication use
• History of drug abuse
• History of painful speculum examination
• Menopausal women
• Women who are pregnant or within 6 weeks of delivery
• Women presenting with dyspareunia, vaginitis, vulvar pain or vulvar lesions
• Women presenting for a vulvar, vaginal or uterine procedure.
• Women who have had a previous abnormal PAP smear (Cervical Intraepithelial Neoplasia \>1)
• Women ≤ 18 years of age.
• Women who have never had vaginal intercourse.
• Women who have never had a speculum examination in the past

Sponsors & Collaborators

• St. John Health System, Michigan: lead

Study Sites (1)

St John Macomb Oakland Hospital

Warren, Michigan, 48093, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 11, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

US (1)