πŸ›οΈ Verified NIH Record β€’ Updated 2024-05-01

RCT of Pain Perception With Fast and Slow Tenaculum Application (NCT05458037)

A Randomized Controlled Trial of Pain Perception With Fast and Slow Tenaculum Application to the Uterine Cervix

🟒 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Women and Infants Hospital of Rhode Island

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Women and Infants Hospital β€” Providence, Rhode Island

Age range: 18 Years

πŸ§ͺ Interventions in This Study

  • Speed of tenaculum application (PROCEDURE)

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • Women and Infants Hospital β€” Providence, Rhode Island

πŸ“ž Contact the Study Coordinator

Phone: (401) 274-1122

Email: RHAllen@wihri.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Pain, Acute clinical trials

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—