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Recruiting

NCT Number: NCT06240260

TENS Unit for Analgesia During IUD Insertion

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.

Recruiting

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Key information

Age range

12 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Location contact

Alysa St. Charles, MA

CONTACT

[email protected]

617-636-9897

Andrea Zuckerman, MD

PRINCIPAL_INVESTIGATOR

Caitie McCarthy, MD

SUB_INVESTIGATOR

Danielle Roncari, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: TENS (transcutaneous electrical nerve stimulation) machine

Standard care

Other

Paracervical block only or participant declines analgesia for IUD insertion

Primary outcomes

  1. Self reported pain intensity from participants during IUD insertion

    Time frame: Day 1

    Survey responses

Secondary outcomes

  1. Pain at other time points during IUD insertion procedure

    Time frame: Day 1

    Survey responses

  2. Rate of vasovagal responses

    Time frame: Day 1

    Participant observation

  3. Likelihood to recommend pain management regiment to a friend for same procedure

    Time frame: Day 1

    Survey responses

Study contacts

Contact information is provided by the study sponsor or research team.

Caitie McCarthy, MD

CONTACT

[email protected]

617-636-9897

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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