TENS Unit for Analgesia During IUD Insertion

January 31, 2024 updated by: Tufts Medical Center

Utilization of Transcutaneous Electrical Nerve Stimulation (TENS) Unit for Analgesia During IUD Insertion: A Prospective Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Persons with a uterus desiring insertion of intrauterine device
  2. Able to provide informed consent/assent
  3. Age 12-50 years old
  4. Minors 12 years of age and older will be included in the study if postmenarchal

Exclusion Criteria:

  1. Unable to provide informed consent/assent
  2. Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
  3. Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
  4. Cutaneous damage at the TENS electrode sites
  5. Chronic or pre-procedure use of opioids
  6. Chronic pain diagnosis
  7. Prior IUD insertion

  8. Any contraindication to intrauterine device (IUD):

    1. Pregnancy
    2. Uterine anomaly that distorts the uterine cavity
    3. Acute pelvic inflammatory disease (PID)
    4. Postpartum endometritis or infected abortion in the past 3 months
    5. Unexplained abnormal uterine bleeding
    6. Wilson's disease or copper allergy (contraindication to copper IUD only)
    7. Breast cancer (contraindication to levonorgestrel IUD only

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS unit
Patients who choose to use a TENS unit for their IUD insertion procedure
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 Names:
  • TENS (transcutaneous electrical nerve stimulation) machine
Active Comparator: Standard care
Patients who decline to use a TENS unit for their IUD insertion procedure
Other: Standard care
Paracervical block only or participant declines analgesia for IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported pain intensity from participants during IUD insertion
Time Frame: One day
Survey responses
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at other time points during IUD insertion procedure
Time Frame: One day
Survey responses
One day
Rate of vasovagal responses
Time Frame: One day
Participant observation
One day
Likelihood to recommend pain management regiment to a friend for same procedure
Time Frame: One day
Survey responses
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Investigators

  • Principal Investigator: Andrea Zuckerman, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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