RCT of Pain Perception With Fast and Slow Tenaculum Application

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT05458037
Status
Recruiting
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Conditions

  • Pain, Acute
  • Pain, Procedural

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Speed of tenaculum application — PROCEDURE
    Fast or slow closure of the tenaculum for application to the uterine cervix

Study Details

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.

Key Dates

Start date
Sep 29, 2020
Status verified
May 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fast tenaculum application
  • Experimental: Slow tenaculum application

Primary Outcome Measure

Pain perception with tenaculum application [ Time Frame: during procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women and Infants HospitalProvidenceRhode Island02905
Rebecca Allen

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By research site
Women and Infants Hospital· Providence, RI

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