Skip to main content
OpenTrials
Completed

NCT Number: NCT03785548

Utilization of the Mirror During Pelvic Exams

This is a prospective cohort study to determine if using a birthing mirror during the patient's pelvic examination decreases patients's degree of vulnerability and discomfort.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Exam

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate nature, pelvic examinations may result in loss of control, embarrassment, discomfort and anxiety.

The mirror pelvic exam has been a proposed technique to decrease patient anxiety and improve comfort during an already uncomfortable examination. However, little research has focused on this modality to date.

The purpose of this study is to investigate whether the mirror pelvic exam decreases the level of vulnerability and discomfort experienced during the pelvic examination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New patients undergoing a pelvic exam performed by a physician at Cincinnati Urogynecology Associates, TriHealth

Exclusion criteria

  • Existing patients
  • Unwillingness to participate in the study
  • Physical or mental impairment that would affect the subject's ability to visualize the mirror during examination or to complete questionnaires
  • Inability to understand English

Treatment and study plan

Usage of a mirror

Other

using a mirror during the pelvic examination

Primary outcomes

  1. Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability

    Time frame: 30 minutes after the pelvic exam

    VAS on vulnerability level will be measured after the pelvic exam, and group difference after controlling for baseline vulnerability, will be calculated. The VAS is a validated 100 millimeter scale with 'no vulnerability' represented as 0 mm and 'very vulnerable' equating to 100 mm.

  2. Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort

    Time frame: 30 minutes after the pelvic exam

    VAS on discomfort level will be measured after the pelvic exam, and group difference after controlling for baseline discomfort level, will be calculated. The VAS is a validated 100 millimeter scale with 'no pain' represented as 0 mm and 'most pain' equating to 100 mm.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Utilization of the Mirror During Pelvic Exams: Does it Reduce Patient Vulnerability and Discomfort?

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2018
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.