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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain perception with tenaculum application

Trial Design

2Treatment groups

Experimental Treatment

Group I: Slow tenaculum applicationExperimental Treatment1 Intervention

Group II: Fast tenaculum applicationExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor

110 Previous Clinical Trials

38,663 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have volunteered to participate in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research study is actively searching for volunteers; it was initially posted on September 29th 2020 and last updated July 13th 2022. The investigators are currently registering 150 individuals across one site."

Answered by AI

Are innovative participants being sought for this research project?

"Affirmative. According to clinicaltrials.gov, this research trial is actively looking for participants, having been posted on September 29th 2020 and updated most recently on July 13th 2022. One hundred fifty volunteers need to be recruited from one site."

Answered by AI

Recent research and studies

Academic Emergency MedicineJournal

Reliability of the Visual Analog Scale for Measurement of Acute Pain

Bijur, Polly E., Wendy Silver, and E. John Gallagher. 2001. “Reliability of the Visual Analog Scale for Measurement of Acute Pain”. Academic Emergency Medicine. Wiley. doi:10.1111/j.1553-2712.2001.tb01132.x.

BMJ Sexual & Reproductive HealthJournal

Pain Perception with Cervical Tenaculum Placement During Intrauterine Device Insertion: A Randomised Controlled Trial

Lambert, Tashima, Tracy Truong, and Beverly Gray. 2019. “Pain Perception with Cervical Tenaculum Placement During Intrauterine Device Insertion: A Randomised Controlled Trial”. BMJ Sexual & Reproductive Health. BMJ. doi:10.1136/bmjsrh-2019-200376.

ContraceptionJournal

Effect of an Atraumatic Vulsellum Versus a Single-tooth Tenaculum on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial

Doty, Nora, and Laura MacIsaac. 2015. “Effect of an Atraumatic Vulsellum Versus a Single-tooth Tenaculum on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2015.05.009.

Obstetrics and Gynecology Clinics of North AmericaJournal