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

IUD Insertion Pain Clinical Trial

Official title:

Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335823
• Other study ID #: STUDY20231621
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Jean M Marino, APRN-CNP
• Phone: 440-720-3250
• Email: Jean.Marino[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• IUD Insertion Pain

Intervention

Device:
• 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 have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
• 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 have the TENS unit will not be turned on.

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jean Marino

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain during IUD insertion as measured by the VAS score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	baseline
Primary	Pain during IUD insertion as measured by the VAS score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	IUD placement/introducer removal up to 5 minute
Secondary	Pain during IUD insertion as measured by the VAS score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	speculum placement up to 1 minute
Secondary	Pain during IUD insertion as measured by the VAS score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	tenaculum placement up to 1 minute
Secondary	Pain during IUD insertion as measured by the VAS score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	sound insertion up to 5 minute
Secondary	Pain during IUD insertion as measured by the VAS score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	5 minute post IUD insertion