A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort (GYN)

A Randomized Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort

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.

Study Overview

• Status: Completed
• Conditions: Patient Comfort

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Metal Speculum; exam with metal speculum
Plastic Speculum; exam with plastic speculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. John Health System, Michigan

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Discomfort; Plastic; Metal; Speculum; Visual Analoge Scale
• Other Study ID Numbers: macomb0001