Clinical trial NCT01788124: A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
Official title: A Randomized Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Comfort
Keywords: Speculum
Metal
Plastic
Visual Analoge Scale
Discomfort
Lead sponsor: St. John Health System, Michigan
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women greater than 18 years of age presenting for routine speculum exam

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Discomfort VAS
timeFrame: up to one day post exam
Secondary outcomes:
Other outcomes:
Locations:
city: Warren
country: United States
facility: St John Macomb Oakland Hospital
state: Michigan
Study officials:
References: