Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Insertion Pain

Not Applicable

Recruiting

• Conditions: Pain

• Registration Number: NCT07044622
• Lead Sponsor: Yale University

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 or replacement during ambulatory care visits at the Center for Women's Health and Midwifery and Yale Family Planning Clinic. Allocation to treatment will be based on a 1:1 blocked randomization scheme. A member of the research/clinical staff other than the provider performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The research staff 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, the provider 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 three 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. If applicable, immediately after IUD removal

5. Immediately after tenaculum placement

6. Immediately after uterine sounding

7. Immediately after IUD insertion

8. 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, and their past experiences. Clinical Providers who perform the IUD insertion will be asked to take a post IUD insertion survey. This survey will ask questions about the insertion and perceived patient pain.

Participation in the study is expected to only last one day, the day of IUD insertion.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2025-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain reported on Visual Analog Scale (VAS)	Day 1 (Day of IUD insertion)	Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.

Secondary Outcome Measures

Name	Time	Method
Post Procedure Surveys	Day 1 (Day of IUD insertion)	Identify factors other than exposure to TENS associated with higher reported pain, and the acceptability of the TENS device by both patients and providers. Questions answered as yes or no, or on a 4 to 5-point scale.

Trial Locations

Locations (2)

Center for Women's Health and Midwifery; 🇺🇸 New Haven, Connecticut, United States

Yale Family Planning Clinic; 🇺🇸 New Haven, Connecticut, United States