Utilization of the Mirror During Pelvic Exams

NCT03785548 | Completed Results

• 1 other identifier: 18-107
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Exam

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Mirror group

This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.

Other: Usage of a mirror

No mirror group

This group of patients decline a mirror, and they will undergo the standard pelvic examination.

Interventions

Usage of a mirror OTHER

using a mirror during the pelvic examination

Mirror group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women 18 years of age to 80, who undergo pelvic exam by a physician at Cincinnati Urogynecology Associates, TriHealth will be approached for recruitment.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Tam T, Crisp CC, Hill AM, Aldrich E, Ghodsi V, Yook E, Yeung J, Pauls RN. Utilization of a Mirror During Pelvic Examinations: Does it Improve the Patient's Experience? Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):208-213. doi: 10.1097/SPV.0000000000000975.

  PMID: 33620906 DERIVED

Results Point of Contact

• Title: Tiffanie Tam, Md
• Organization: TriHealth Inc.

Tiffanie_Tam@trihealth.com

513-463-4300

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 24, 2018
• Study Start: April 15, 2019
• Primary Completion: May 29, 2020
• Study Completion: July 1, 2020
• Last Updated: August 17, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)