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TENS Unit for Analgesia During IUD Insertion

NCT06240260 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-04

No results posted yet for this study

Summary

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure:

* anticipated pain during IUD insertion
* baseline pain prior to insertion
* speculum insertion
* tenaculum placement
* paracervical block administration (if performed)
* cervical dilation (if performed)
* uterine sounding
* IUD insertion
* 5 minutes after IUD insertion

Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only.

As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.

Conditions

  • IUD
  • Analgesia
  • Patient Preference
  • Pain, Acute

Interventions

DEVICE

TENS (transcutaneous electrical nerve stimulation) unit

Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of a mild electrical current. A TENS machine is a small, battery-operated device that has leads connected to sticky pads called electrodes.

OTHER

Standard care

Paracervical block only or participant declines analgesia for IUD insertion

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Andrea Zuckerman, MD · Tufts Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06240260 on ClinicalTrials.gov