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Behavioural Intervention

Active TENS for Pain

N/A

Recruiting

Led By Lauren Kus, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

English speaking and age 18 or older

Opting for either LNG 52mg or copper T380A IUD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (day of iud insertion)

Awards & highlights

Study Summary

This trial is testing if using high frequency TENS (Transcutaneous Electrical Nerve Stimulation) can help reduce pain during IUD insertion. TENS is a safe and inexpensive way to manage pain

Who is the study for?

This trial is for individuals experiencing pain during IUD insertion. Participants should be those undergoing the procedure and willing to use a TENS device for pain management. Specific eligibility details are not provided, but typically include being of reproductive age and in good general health.Check my eligibility

What is being tested?

The study tests high frequency TENS as a non-drug method to manage pain during IUD insertion. It's a double-blind trial, meaning neither participants nor researchers know who gets real TENS or placebo. Pain levels will be measured using a visual scale.See study design

What are the potential side effects?

TENS is generally low-risk with minimal side effects which may include skin irritation at the electrode sites, muscle twitching, or discomfort from the electrical current if set too high.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and speak English.

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I am choosing between the LNG 52mg or copper T380A IUD for birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (day of iud insertion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (day of iud insertion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (day of iud insertion) 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 Visual Analog Scale

Secondary outcome measures

Post Procedure Survey

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active TENSActive Control1 Intervention

For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.

Group II: Placebo TENSPlacebo Group1 Intervention

For the placebo TENS group, setup will be identical, but the device will not be turned on.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,528 Total Patients Enrolled

12 Trials studying Pain

1,252 Patients Enrolled for Pain

Lauren Kus, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

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

Are there any ongoing efforts to enroll patients in this current medical study?

"According to the information available on clinicaltrials.gov, this particular research endeavor is not currently seeking participants. Its initial posting was on February 1st, 2024 and it underwent its latest revision on January 30th of that same year. However, amidst a pool of 364 ongoing trials actively enrolling subjects, there are numerous opportunities for potential candidates to consider."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

Lauren Kus 2024. "Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245655.