Clinical Trial

RCT of Pain Perception With Fast and Slow Tenaculum Application

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Summary
This project will be a randomized controlled trial (RCT) measuring pain perception with two different tenaculum placement techniques on the uterine cervix. A tenaculum is an instrument used to hold the cervix (the opening to the uterus or womb) in place. The trial will measure pain perception with a Visual Analog Scale (VAS) from 0 to 100 mm for two different tenaculum placement techniques, fast and slow closure on the uterine cervix. The main objective of this study is to determine if there is a difference in pain perception with fast compared to slow tenaculum placement techniques on the uterine cervix. We hypothesize that the slow technique will be perceived as less painful for subjects as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). Subsidiary objectives include describing overall pain levels during the procedure.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-07-13.
Trial Details
NCT Number NCT05458037
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions Pain, Acute, Pain, Procedural
Enrollment 150 participants
Start Date 2020-09-29
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-05-03