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CompletedNCT01788124GYNUpdated Feb 11, 2013

A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort

An observational study in Patient Comfort, sponsored by St. John Health System, Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-11.

Sponsored by St. John Health System, Michigan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 85 Years
Sex
Female
01

Study 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.

Read the detailed description

Speculum examination is a common procedure in the gynecology clinic used for evaluation of numerous conditions such as vaginitis, and during cervical cytology screening (PAP smears). The speculum is inserted into the woman's vagina and used to keep the vaginal walls apart during exam and procedures. Each step of the examination with a speculum including insertion, manipulation during examination, and removal can cause discomfort for the patient. Fear of examination pain is considered one barrier to examination compliance. Any method to decrease discomfort during the exam would be considered beneficial to patient screening.

Typically two types of speculums are used in clinical practice, metal and plastic. There are advantages to both, and usage is usually predicated by physician preference. Previous studies have demonstrated a clear difference in patient comfort between metal speculums and newer dilating speculums such as the Vera scope (1). Clinical trials have also shown the benefit of using lubrication on metal speculums during routine exams (2). To date there are no clinical trails to examine the difference in patient comfort between metal and plastic bi-valve speculums.

02

Conditions studied

  • Patient Comfort

Keywords

  • Speculum
  • Metal
  • Plastic
  • Visual Analoge Scale
  • Discomfort
03

In context

Lead sponsor

St. John Health System, Michigan is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • Metal Speculum

    exam with metal speculum

  • Plastic Speculum

    exam with plastic speculum

06

What researchers measure

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

    Time frame: up to one day post exam

07

Study locations

1 site
  • St John Macomb Oakland Hospital
    Warren, Michigan 48093, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01788124
Lead sponsor
St. John Health System, Michigan
Responsible party
Michael Shaw PhD (Research Coordinator, St. John Health System, Michigan) — Principal investigator
First posted
Feb 11, 2013
Start date
Jul 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Feb 11, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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