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TENS Unit for Pain Relief During IUD Insertion

N/A
Recruiting
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
Must not have
Contraindication to intrauterine device (IUD): Acute pelvic inflammatory disease (PID)
Unable to provide informed consent/assent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am between 12 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot use an IUD due to having acute pelvic inflammatory disease.
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I am unable to understand or sign the consent form.
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I have unexplained bleeding that makes it unsafe for me to use an IUD.
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I have skin damage where TENS electrodes were placed.
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I have had a procedure to remove abnormal cells from my cervix.
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I am undergoing or have recently had a cervical procedure.
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I have been diagnosed with chronic pain.
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I regularly use opioids for pain management.
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I cannot use levonorgestrel IUD due to having breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Self reported pain intensity from participants during IUD insertion
Secondary study objectives
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

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
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

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
264,428 Total Patients Enrolled
Andrea Zuckerman, MDPrincipal InvestigatorTufts Medical Center
~5 spots leftby Dec 2024
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