Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-04-30
2025-12-31
Brief Summary
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* anticipated pain during IUD insertion
* baseline pain prior to insertion
* speculum insertion
* tenaculum placement
* paracervical block administration (if performed)
* cervical dilation (if performed)
* uterine sounding
* IUD insertion
* 5 minutes after IUD insertion
Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only.
As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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TENS unit
Patients who choose to use a TENS unit for their IUD insertion procedure
TENS (transcutaneous electrical nerve stimulation) unit
Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of a mild electrical current.
A TENS machine is a small, battery-operated device that has leads connected to sticky pads called electrodes.
Standard care
Patients who decline to use a TENS unit for their IUD insertion procedure
Standard care
Paracervical block only or participant declines analgesia for IUD insertion
Interventions
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TENS (transcutaneous electrical nerve stimulation) unit
Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of a mild electrical current.
A TENS machine is a small, battery-operated device that has leads connected to sticky pads called electrodes.
Standard care
Paracervical block only or participant declines analgesia for IUD insertion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to provide informed consent/assent
3. Age 12-50 years old
4. Minors 12 years of age and older will be included in the study if postmenarchal
Exclusion Criteria
2. Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
3. Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
4. Cutaneous damage at the TENS electrode sites
5. Chronic or pre-procedure use of opioids
6. Chronic pain diagnosis
7. Prior IUD insertion
8. Any contraindication to intrauterine device (IUD):
1. Pregnancy
2. Uterine anomaly that distorts the uterine cavity
3. Acute pelvic inflammatory disease (PID)
4. Postpartum endometritis or infected abortion in the past 3 months
5. Unexplained abnormal uterine bleeding
6. Wilson's disease or copper allergy (contraindication to copper IUD only)
7. Breast cancer (contraindication to levonorgestrel IUD only
12 Years
50 Years
FEMALE
Yes
Sponsors
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Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Andrea Zuckerman, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Seyss R. [Bone scan of persisting epiphyseal cartilage]. Fortschr Geb Rontgenstr Nuklearmed. 1974 Nov;121(5):655-6. No abstract available. German.
Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170.
Hurwitz S. Pigmented nevi. Semin Dermatol. 1988 Mar;7(1):17-25. No abstract available.
Kavanaugh ML, Frohwirth L, Jerman J, Popkin R, Ethier K. Long-acting reversible contraception for adolescents and young adults: patient and provider perspectives. J Pediatr Adolesc Gynecol. 2013 Apr;26(2):86-95. doi: 10.1016/j.jpag.2012.10.006. Epub 2012 Dec 31.
Callahan DG, Garabedian LF, Harney KF, DiVasta AD. Will it Hurt? The Intrauterine Device Insertion Experience and Long-Term Acceptability Among Adolescents and Young Women. J Pediatr Adolesc Gynecol. 2019 Dec;32(6):615-621. doi: 10.1016/j.jpag.2019.08.004. Epub 2019 Aug 8.
ACOG Committee Opinion No. 735: Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2018 May;131(5):e130-e139. doi: 10.1097/AOG.0000000000002632.
American College of Obstetricians and Gynecologists' Committee on Gynecologic Practice; Long-Acting Reversible Contraceptive Expert Work Group. Committee Opinion No 672: Clinical Challenges of Long-Acting Reversible Contraceptive Methods. Obstet Gynecol. 2016 Sep;128(3):e69-77. doi: 10.1097/AOG.0000000000001644.
Crawford M, Davy S, Book N, Elliott JO, Arora A. Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. J Obstet Gynaecol Can. 2017 Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014. Epub 2017 Aug 18.
Nagatomo T, Tajiri A, Nakamura T, Hokibara R, Tanaka Y, Aono J, Tsuchihashi H. Adrenergic and serotonergic receptor-blocking potencies of terazosin, a new antihypertensive agent, as assessed by radioligand binding assay. Chem Pharm Bull (Tokyo). 1987 Apr;35(4):1629-32. doi: 10.1248/cpb.35.1629. No abstract available.
Mody SK, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012 Dec;86(6):704-9. doi: 10.1016/j.contraception.2012.06.004. Epub 2012 Jul 6.
Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.
Rignon-Bret JM, Pompignoli M. [Esthetic presentation]. Inf Dent. 1987 Sep 24;69(32):2757-72. No abstract available. French.
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.
Other Identifiers
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STUDY00004077
Identifier Type: -
Identifier Source: org_study_id
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