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TENS unit for Pain relief

N/A

Waitlist Available

Led By Andrea Zuckerman, MD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-50 years old

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one day

Awards & highlights

Study Summary

"This trial involves screening subjects over the phone or at a clinic to see if they can participate. If eligible and interested, they will sign a consent form and then be enrolled in the study. Patients can

Who is the study for?

This trial is for individuals who are planning to have an IUD (intrauterine device) inserted and are interested in trying a TENS (transcutaneous electrical nerve stimulation) unit for pain relief during the procedure. Participants will be screened over the phone or at Tufts GYN clinic.Check my eligibility

What is being tested?

The study is testing if using a TENS unit can help reduce pain during IUD insertion compared to standard care, which may include NSAIDs, paracervical block, and heating pads. Pain scores will be recorded at various stages of the insertion process.See study design

What are the potential side effects?

TENS units are generally safe but might cause skin irritation where the pads attach, muscle twitching, or discomfort from the electrical current. Standard care side effects depend on treatments used like stomach issues with NSAIDs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 12 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one day

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

Treatment Details

Study Objectives

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

Primary outcome measures

Self reported pain intensity from participants during IUD insertion

Secondary outcome measures

Likelihood to recommend pain management regiment to a friend for same procedure

Pain at other time points during IUD insertion procedure

Rate of vasovagal responses

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TENS unitExperimental Treatment1 Intervention

Patients who choose to use a TENS unit for their IUD insertion procedure

Group II: Standard careActive Control1 Intervention

Patients who decline to use a TENS unit for their IUD insertion procedure

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor

255 Previous Clinical Trials

255,218 Total Patients Enrolled

Andrea Zuckerman, MDPrincipal InvestigatorTufts Medical Center

Frequently Asked Questions

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

What are the specific criteria for individuals who can participate in this medical study?

"Candidates must be aged between 12 and 50 years old, demonstrate patient preference, with a total of 40 candidates being considered for inclusion in the trial."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, recruitment for this particular trial has ceased. The initial posting date was April 30th, 2024, with the latest update made on January 31st, 2024. Although enrollment is closed for this study, it's noteworthy that there are currently 217 other trials actively seeking participants."

Answered by AI