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Speed of Tenaculum Application for Procedural Pain

N/A
Recruiting
Led By Rebecca Allen, MD
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two different techniques for placing a tenaculum on the cervix to measure which is less painful. The visual analog scale will be used to measure pain levels from 0-100mm. The main objective is to determine if there is a difference in pain perception with the two techniques. It is hypothesized that the slow technique will be perceived as less painful.

Who is the study for?
This trial is for women aged 18-49 planning to get an IUD or endometrial biopsy, who can consent and haven't used painkillers, anxiety meds, narcotics, or illegal drugs recently.
What is being tested?
The study compares two ways of using a tenaculum during gynecological procedures: fast vs. slow application. It aims to see which method causes less pain as measured by a pain scale.
What are the potential side effects?
While the trial itself doesn't involve medication with side effects, the use of the tenaculum may cause discomfort or pain at the site of application on the cervix.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain perception with tenaculum application

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Slow tenaculum applicationExperimental Treatment1 Intervention
Group II: Fast tenaculum applicationExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor
114 Previous Clinical Trials
40,200 Total Patients Enrolled
Rebecca Allen, MDPrincipal InvestigatorWomen & Infants Hospital

Media Library

Speed of tenaculum application Clinical Trial Eligibility Overview. Trial Name: NCT05458037 — N/A
Procedural Pain Research Study Groups: Fast tenaculum application, Slow tenaculum application
Procedural Pain Clinical Trial 2023: Speed of tenaculum application Highlights & Side Effects. Trial Name: NCT05458037 — N/A
Speed of tenaculum application 2023 Treatment Timeline for Medical Study. Trial Name: NCT05458037 — N/A
~49 spots leftby Dec 2026
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