Trial Outcomes & Findings for Utilization of the Mirror During Pelvic Exams (NCT NCT03785548)

NCT ID: NCT03785548

Last Updated: 2020-08-17

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 147 participants
• Primary outcome timeframe: 30 minutes after the pelvic exam
• Results posted on: 2020-08-17

Participant Flow

Participant milestones

Measure	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. Usage of a mirror: using a mirror during the pelvic examination	No Mirror Group This group of patients decline a mirror, and they will undergo the standard pelvic examination.
Overall Study STARTED	73	74
Overall Study COMPLETED	71	74
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	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. Usage of a mirror: using a mirror during the pelvic examination	No Mirror Group This group of patients decline a mirror, and they will undergo the standard pelvic examination.
Overall Study age > 80	1	0
Overall Study no Postop queries	1	0

Baseline Characteristics

Utilization of the Mirror During Pelvic Exams

Baseline characteristics by cohort

Measure	Mirror Group n=71 Participants 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. Usage of a mirror: using a mirror during the pelvic examination	No Mirror Group n=74 Participants This group of patients decline a mirror, and they will undergo the standard pelvic examination.	Total n=145 Participants Total of all reporting groups
Age, Continuous	53.99 years STANDARD_DEVIATION 12.96 • n=5 Participants	57.84 years STANDARD_DEVIATION 13.86 • n=7 Participants	55.95 years STANDARD_DEVIATION 13.52 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	74 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	62 Participants n=5 Participants	66 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Prefer not to answer	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants	74 participants n=7 Participants	145 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after the pelvic exam

Population: There are 2 missing outcomes from Mirror group

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.

Outcome measures

Measure	Mirror Group n=69 Participants 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. Usage of a mirror: using a mirror during the pelvic examination	No Mirror Group n=74 Participants This group of patients decline a mirror, and they will undergo the standard pelvic examination.
Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability	13.294 mm Standard Error 1.854	16.145 mm Standard Error 1.789

PRIMARY outcome

Timeframe: 30 minutes after the pelvic exam

Population: Each group has 1 missing outcome.

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.

Outcome measures

Measure	Mirror Group n=70 Participants 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. Usage of a mirror: using a mirror during the pelvic examination	No Mirror Group n=73 Participants This group of patients decline a mirror, and they will undergo the standard pelvic examination.
Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort	19.683 mm Standard Error 2.201	19.824 mm Standard Error 2.154

Adverse Events

Mirror Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Mirror Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tiffanie Tam, Md

TriHealth Inc.

Phone: 513-463-4300

Email: Tiffanie_Tam@trihealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place