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

University Hospitals (UH)

Status: Completed

Conditions: IUD Insertion Pain

Treatments: Device: Placebo Transcutaneous electrical nerve stimulation (TENS); Device: Transcutaneous electrical nerve stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06335823

STUDY20231621

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Active TENS unit

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS)

Non-active TENS unit

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Transcutaneous electrical nerve stimulation (TENS)