TENS Unit for Analgesia During IUD Insertion

Analgesia Clinical Trial

Official title:

Utilization of Transcutaneous Electrical Nerve Stimulation (TENS) Unit for Analgesia During IUD Insertion: A Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240260
• Other study ID #: STUDY00004077
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Tufts Medical Center
• Contact: Caitie McCarthy, MD
• Phone: 617-636-9897
• Email: caitlin.mccarthy[@]tuftsmedicine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure:

• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Persons with a uterus desiring insertion of intrauterine device

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:

1. Unable to provide informed consent/assent

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• IUD
• Pain, Acute
• Patient Preference

Intervention

Device:
• 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.

Other:
• Standard care
Paracervical block only or participant declines analgesia for IUD insertion

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fleming KL, Sokoloff A, Raine TR. Attitudes and beliefs about the intrauterine device among teenagers and young women. Contraception. 2010 Aug;82(2):178-82. doi: 10.1016/j.contraception.2010.02.020. Epub 2010 Apr 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Chem Pharm Bull (Tokyo) 1987 Jan;35(6):2622. — View Citation

Potter J, Rubin SE, Sherman P. Fear of intrauterine contraception among adolescents in New York City. Contraception. 2014 May;89(5):446-50. doi: 10.1016/j.contraception.2014.01.011. Epub 2014 Jan 21. — View Citation

Rignon-Bret JM, Pompignoli M. [Esthetic presentation]. Inf Dent. 1987 Sep 24;69(32):2757-72. No abstract available. French. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported pain intensity from participants during IUD insertion	Survey responses	One day
Secondary	Pain at other time points during IUD insertion procedure	Survey responses	One day
Secondary	Rate of vasovagal responses	Participant observation	One day
Secondary	Likelihood to recommend pain management regiment to a friend for same procedure	Survey responses	One day