Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

NCT ID: NCT06245655

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2025-04-21

Brief Summary

This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.

Detailed Description

The researchers will recruit eligible participants from patients who opt for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service at Mount Sinai Hospital, Mount Sinai Beth Israel, Mount Sinai Morningside, and Mount Sinai West. Allocation to treatment will be based on a 1:1 blocked randomization scheme stratified by parity. A member of the research/clinical team other than the person performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The team member will set up the TENS unit accordingly by applying pads to the participant and initiating treatment with the correct settings. When setup is complete (<5 minutes), the person performing the IUD insertion and other clinical staff assisting with the procedure will enter the exam room with no knowledge of TENS treatment assignment to insert the IUD.

REDCap, a HIPAA-compliant, secure web application used for building and managing online surveys and databases, will be used for data collection in this study. Participants will complete electronic surveys in REDCap during the study. The first survey is a baseline survey to collect demographics as well as medical, obstetric, and gynecologic history and other characteristics prior to the IUD insertion procedure.

IUD insertion will be performed by complex family planning faculty and fellows, as well as OB/GYN residents on their family planning rotation. A research staff member will be within reach of the study participant during the procedure to collect pain scores using a visual analog scale (VAS) presented on an iPad.

The second survey will have a visual analog scale for study participants to rate their pain between 0 and 100 at the following timepoints during IUD insertion:

1. Baseline

2. Immediately after bimanual exam

3. Immediately after speculum insertion

4. Immediately after tenaculum placement

5. Immediately after uterine sounding

6. Immediately after IUD insertion

7. 5 minutes after speculum removal

The third survey will ask participants about reflections on their experience with IUD insertion and acceptability of the TENS device. Participation in the study is expected to only last one day, the day of IUD insertion.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active TENS

For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: DEVICE

TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.

Placebo TENS

For the placebo TENS group, setup will be identical, but the device will not be turned on.

Group Type: PLACEBO_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: DEVICE

TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)

TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

In order to participate in the study, an individual must meet all the following criteria:

• Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service
• Provision of signed and dated informed consent form for IUD Insertion
• English speaking and age 18 or older
• Opting for either LNG 52mg or copper T380A IUD
• Stated willingness to comply with all study procedures

Exclusion Criteria

• Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy)
• Contraindication or allergy to ibuprofen
• History of a chronic pain disorder
• Recent opioid use in the previous 30 days
• History of a cardiac arrhythmia
• History of heart disease (i.e. atrial fibrillation, congestive heart failure)
• Presence of an implantable device with an electrical discharge (i.e. pacemaker)
• BMI > 50 (class IV obesity)
• History of TENS use
• Planned pain intervention outside standard of care (i.e. paracervical block) OR pre-procedure use of non-standard pain medication (i.e. benzodiazepines, muscle relaxers, gabapentin, benadryl)
• History of epilepsy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Lauren Kus

Complex Family Planning Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren Kus, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Center for Women's Health and Midwifery

New Haven, Connecticut, United States

Yale Family Planning Clinic

New Haven, Connecticut, United States

Mount Sinai Beth Israel

New York, New York, United States

Mount Sinai Union Square

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

SFP17-UL4

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY-23-01562

Identifier Type: -

Identifier Source: org_study_id