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NCT03785548

Utilization of the Mirror During Pelvic Exams

Completed Results posted Last updated 17 August 2020
What this trial tests

trial testing Usage of a mirror in Pelvic Exam in 147 participants. Completed in 1 July 2020.

Timeline
15 April 2019
Primary endpoint
29 May 2020
1 July 2020

Quick facts

Lead sponsorTriHealth Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment147
Start date15 April 2019
Primary completion29 May 2020
Estimated completion1 July 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

TriHealth Inc. — full company profile →

Who can join

Adults 18 to 80, female only, with Pelvic Exam. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Mirror Group13.294± 1.854
No Mirror Group16.145± 1.789
Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort Primary · 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.

GroupValue95% CI
Mirror Group19.683± 2.201
No Mirror Group19.824± 2.154

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Utilization of a Mirror During Pelvic Examinations: Does it Improve the Patient's Experience?
    Tam T, Crisp CC, Hill AM, Aldrich E, et al · · 2021 · cited 2× · PMID 33620906 · DOI 10.1097/spv.0000000000000975

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Other TriHealth Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03785548.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing