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RCT of Pain Perception With Fast and Slow Tenaculum Application

NCT05458037 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-05-03

No results posted yet for this study

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.

Conditions

  • Pain, Acute
  • Pain, Procedural

Interventions

PROCEDURE

Speed of tenaculum application

Fast or slow closure of the tenaculum for application to the uterine cervix

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Rebecca Allen, MD · Women & Infants Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05458037 on ClinicalTrials.gov