Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Insertion Pain

NCT07044622 | Withdrawn FDA Device

• 1 other identifier: 2000038467
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.

Conditions

Pain

Keywords

IUD; TENS

Outcome Measures

Primary Outcomes (1)

• Pain reported on Visual Analog Scale (VAS)

  Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.

  Day 1 (Day of IUD insertion)

Secondary Outcomes (1)

• Post Procedure Surveys

  Day 1 (Day of IUD insertion)

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Placebo TENS

PLACEBO COMPARATOR

For the placebo TENS group, setup will be identical, but the device will not be turned on.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

The TENS 7000 digital TENS unit is a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.

Active TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• English-speaking individual aged 18 years or older.
• Presenting for IUD initiation or replacement during ambulatory care visits to the Yale Family Planning service and Center for Women's Health and Midwifery clinic.
• Opting for either LNG 52mg or copper T380A IUD.
• Review of the provider participant study Information Sheet and provision of verbal consent.
• IUD insertion performed by Yale Family Planning and Center for Women's Health and Midwifery clinic faculty and fellows, as well as OB/GYN residents on their family planning rotation, with IUD insertion competency.
• Performing an IUD insertion on a patient participant who meets all patient participant eligibility criteria

You may not qualify if:

• Contraindication to IUD initiation
• Current Pelvic Infection
• Distorted Uterine Anatomy (I.e., uterine septum, didelphys, uterine fibroids with cavity length greater than 12mm)
• Pregnancy
• Any other contraindications to IUD insertion as determined by the patient's clinical care staff.
• Current IUD with no visible strings
• Contraindication or allergy to ibuprofen
• History of chronic pain disorder
• Recent opioid use in the previous 30 days
• History of cardiac arrhythmia
• History of heart disease (i.e., atrial fibrillation, congestive heart failure)
• Presence of an implantable device with an electrical discharge (i.e., pacemaker)
• History of epilepsy
• BMI \> 50
• History of TENS use

Sponsors & Collaborators

• Yale University: lead
• Society of Family Planning: collaborator

Study Sites (2)

Center for Women's Health and Midwifery

New Haven, Connecticut, 06519, United States

Location

Yale Family Planning Clinic

New Haven, Connecticut, 06519, United States

Location

Related Publications (24)

• Gero A, Elliott S, Baayd J, Cohen S, Simmons RG, Gawron LM. Factors associated with a negative Patient Acceptable Symptom State (PASS) response with intrauterine device placement: A retrospective survey of HER Salt Lake participants. Contraception. 2024 May;133:110385. doi: 10.1016/j.contraception.2024.110385. Epub 2024 Feb 1.

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  PMID: 24882426 BACKGROUND

• Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.

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• Lohr PA, Lyus R, Prager S. Use of intrauterine devices in nulliparous women. Contraception. 2017 Jun;95(6):529-537. doi: 10.1016/j.contraception.2016.08.011. Epub 2016 Aug 31.

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• Pergialiotis V, Vlachos DG, Protopappas A, Vlachos GD. Analgesic options for placement of an intrauterine contraceptive: a meta-analysis. Eur J Contracept Reprod Health Care. 2014 Jun;19(3):149-60. doi: 10.3109/13625187.2014.903238. Epub 2014 May 14.

  PMID: 24828514 BACKGROUND

• Shahnazi M, Nikjoo R, Yavarikia P, Mohammad-Alizadeh-Charandabi S. Inhaled lavender effect on anxiety and pain caused from intrauterine device insertion. J Caring Sci. 2012 Nov 28;1(4):255-61. doi: 10.5681/jcs.2012.035. eCollection 2012 Dec.

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• Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25.

  PMID: 31882291 BACKGROUND

• Cimsir MT, Yildiz MS. Could the Valsalva manoeuvre be an alternative to the tenaculum for intrauterine device insertion? Eur J Contracept Reprod Health Care. 2021 Dec;26(6):503-506. doi: 10.1080/13625187.2021.1934442. Epub 2021 Jun 11.

  PMID: 34114522 BACKGROUND

• Rahman M, King C, Saikaly R, Sosa M, Sibaja K, Tran B, Tran S, Morello P, Yeon Seo S, Yeon Seo Y, Jacobs RJ. Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. Cureus. 2024 Mar 8;16(3):e55785. doi: 10.7759/cureus.55785. eCollection 2024 Mar.

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• Gemzell-Danielsson K, Jensen JT, Monteiro I, Peers T, Rodriguez M, Di Spiezio Sardo A, Bahamondes L. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019 Dec;98(12):1500-1513. doi: 10.1111/aogs.13662. Epub 2019 Jun 27.

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• Babazadeh-Zavieh SS, Bashardoust Tajali S, Haeri SMJ, Shamsi A. Effects of Transcutaneous Electrical Nerve Stimulation on Chronic Pelvic Pain in Women: A Systematic Review and Meta-Analysis. Complement Med Res. 2023;30(2):161-173. doi: 10.1159/000528133. Epub 2022 Nov 21.

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• Guy M, Foucher C, Juhel C, Rigaudier F, Mayeux G, Levesque A. Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo. Prog Urol. 2022 Jul;32(7):487-497. doi: 10.1016/j.purol.2022.01.005. Epub 2022 Mar 3.

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• Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.

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• Njogu A, Qin S, Chen Y, Hu L, Luo Y. The effects of transcutaneous electrical nerve stimulation during the first stage of labor: a randomized controlled trial. BMC Pregnancy Childbirth. 2021 Feb 24;21(1):164. doi: 10.1186/s12884-021-03625-8.

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• Gopalkrishnan P, Sluka KA. Effect of varying frequency, intensity, and pulse duration of transcutaneous electrical nerve stimulation on primary hyperalgesia in inflamed rats. Arch Phys Med Rehabil. 2000 Jul;81(7):984-90. doi: 10.1053/apmr.2000.5576.

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Related Links

• Long-Acting Reversible Contraception Implants and Intrauterine Devices
• Patient-Reported Outcomes Measurement Information System Global-10, PROMIS Global-10. APTA

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Tessa Madden, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)