Utilization of the Mirror During Pelvic Exams

Pelvic Exam Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785548
• Other study ID #: 18-107
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: July 1, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Exam

Intervention

Other:
• Usage of a mirror
using a mirror during the pelvic examination

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability	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.	30 minutes after the pelvic exam
Primary	Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort	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.	30 minutes after the pelvic exam