TENS Unit for Analgesia During IUD Insertion

NCT06240260 | Recruiting FDA Device

• 1 other identifier: STUDY00004077
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

iud; contraception; iud placement; pain management; teen

Outcome Measures

Primary Outcomes (1)

• Self reported pain intensity from participants during IUD insertion

  Survey responses

  Day 1

Secondary Outcomes (3)

• Pain at other time points during IUD insertion procedure

  Day 1

• Rate of vasovagal responses

  Day 1

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

  Day 1

Study Arms (2)

TENS unit

EXPERIMENTAL

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

Device: TENS (transcutaneous electrical nerve stimulation) unit

Standard care

ACTIVE COMPARATOR

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

Other: Standard care

Interventions

TENS (transcutaneous electrical nerve stimulation) unit DEVICE

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.

Also known as: TENS (transcutaneous electrical nerve stimulation) machine

TENS unit

Standard care OTHER

Paracervical block only or participant declines analgesia for IUD insertion

Standard care

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Unable to provide informed consent/assent
• Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
• Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
• Cutaneous damage at the TENS electrode sites
• Chronic or pre-procedure use of opioids
• Chronic pain diagnosis
• Prior IUD insertion
• Any contraindication to intrauterine device (IUD):
• Pregnancy
• Uterine anomaly that distorts the uterine cavity
• Acute pelvic inflammatory disease (PID)
• Postpartum endometritis or infected abortion in the past 3 months
• Unexplained abnormal uterine bleeding
• Wilson's disease or copper allergy (contraindication to copper IUD only)
• Breast cancer (contraindication to levonorgestrel IUD only

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

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MeSH Terms

Conditions

Agnosia; Patient Preference; Acute Pain; Stillbirth

Interventions

Transcutaneous Electric Nerve Stimulation; Standard of Care

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior; Pain; Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrea Zuckerman, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitie McCarthy, MD

CONTACT

617-636-9897; caitlin.mccarthy@tuftsmedicine.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: February 5, 2024
• Study Start: April 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)