Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology

Not Applicable

Completed

• Conditions: IUD Insertion Pain
• Interventions: Device: Placebo Transcutaneous electrical nerve stimulation (TENS); Device: Transcutaneous electrical nerve stimulation (TENS)

• Registration Number: NCT06335823
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Study Start: 2024-06-05
• Status Verified: 2025-02
• Primary Completion: 2025-02-07
• Study Completion: 2025-02-07
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Age 18-45 years old
• Individuals with a cervix and uterus
• Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
• Meet medical eligibility for IUD placement
• Ability to consent in English
• Ability to use the visual analogue scale (VAS)

Exclusion Criteria

• Contraindications to IUD placement
• Use of analgesics within the last 4 hours prior to IUD placement
• Presence of a pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-active TENS unit	Placebo Transcutaneous electrical nerve stimulation (TENS)	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Active TENS unit	Transcutaneous electrical nerve stimulation (TENS)	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.

Primary Outcome Measures

Name	Time	Method
Pain during IUD insertion as measured by the VAS score	IUD placement/introducer removal up to 5 minute	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

Secondary Outcome Measures

Name	Time	Method
Pain during IUD insertion as measured by the VAS score	5 minute post IUD insertion	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States