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Completed

NCT Number: NCT06335823

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.

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Key information

Conditions

IUD Insertion Pain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain During IUD Insertion as Measured by the VAS Score

    Time frame: 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 outcomes

  1. Pain During IUD Insertion as Measured by the VAS Score

    Time frame: speculum placement up to 1 minute

    The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

  2. Pain During IUD Insertion as Measured by the VAS Score

    Time frame: tenaculum placement up to 1 minute

    The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

  3. Pain During IUD Insertion as Measured by the VAS Score

    Time frame: sound insertion 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

  4. Pain Post IUD Insertion as Measured by the VAS Score

    Time frame: 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

Other outcomes

  1. Pain Prior to IUD Insertion as Measured by the VAS Score

    Time frame: baseline

    The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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