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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: IUD Insertion Pain
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation (TENS); Device: Placebo Transcutaneous electrical nerve stimulation (TENS)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean M Marino, APRN-CNP; Phone Number: 440-720-3250; Email: Jean.Marino@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals
      • Contact: Jean M Marino, APRN-CNP; Phone Number: 440-720-3250; Email: Jean.Marino@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TENS unit; 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.	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 Comparator: Non-active TENS unit; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jean Marino
• Investigators: Principal Investigator: Jean M Marino, APRN-CNP, University Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: contraception
• Other Study ID Numbers: STUDY20231621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No