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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken any strong pain medication in the last 24 hours.You have taken any anxiety medication or drug within the past 24 hours.You have taken NSAIDS or Tylenol in the last 12 hours.You are between 18 and 49 years old.You have not taken pain relievers or anxiety medications in the last 24 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Fast tenaculum application
- Group 2: Slow tenaculum application
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.