A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort

NCT ID: NCT01788124

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Patient Comfort

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Metal Speculum

exam with metal speculum

No interventions assigned to this group

Plastic Speculum

exam with plastic speculum

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. John Health System, Michigan

OTHER

Sponsor Role: lead

Responsible Party

Michael Shaw PhD

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St John Macomb Oakland Hospital

Warren, Michigan, United States

Countries

United States

Other Identifiers

macomb0001

Identifier Type: -

Identifier Source: org_study_id