NCT06335823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 2, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

March 21, 2024

Results QC Date

January 20, 2026

Last Update Submit

February 27, 2026

Conditions

IUD Insertion Pain

Keywords

contraception

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pain During IUD Insertion as Measured by the VAS Score

    speculum placement up to 1 minute

  • Pain During IUD Insertion as Measured by the VAS Score

    tenaculum placement up to 1 minute

  • Pain During IUD Insertion as Measured by the VAS Score

    sound insertion up to 5 minute

  • Pain Post IUD Insertion as Measured by the VAS Score

    5 minute post IUD insertion

Other Outcomes (1)

  • Pain Prior to IUD Insertion as Measured by the VAS Score

    baseline

Study Arms (2)

Active TENS unit

EXPERIMENTAL

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)

Non-active TENS unit

PLACEBO COMPARATOR

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)

Interventions

Transcutaneous electrical nerve stimulation (TENS)DEVICE

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.

Active TENS unit
Placebo Transcutaneous electrical nerve stimulation (TENS)DEVICE

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.

Non-active TENS unit

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Results Point of Contact

Title
Jean Marino
Organization
University Hospitals Cleveland Medical Center
jean@kultivatewomenshealth.com
216-844-8879

Study Officials

  • Jean M Marino, APRN-CNP

    University Hospitals

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 28, 2024

Study Start

June 5, 2024

Primary Completion

February 7, 2025

Study Completion

February 7, 2025

Last Updated

March 2, 2026

Results First Posted

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)