Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial

NCT07714590 | Not Yet Recruiting FDA Device

• 2 other identifiers: Pro00118748391001436
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to learn if placing a vibrating device at the umbilicus during insertion of intrauterine device (IUD) decreases perceived pain during the procedure. The main question it aims to answer is: Does applying a vibrating device to the umbilicus during IUD insertion significantly reduce perceived pain compared to standard of care? Researchers will compare pain scores during IUD insertion among patients who received the vibrating device at the umbilicus and those who did not. Participants will be randomly assigned to receive a vibrating device placed on the umbilicus during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device. Participants will complete a pre-procedure survey and will report their pain on a scale of 1-100 at various points during the IUD insertion procedure. Participants who received the vibrating device will also complete a post-procedure survey.

Conditions

Intrauterine Device Placement

Keywords

intrauterine device

Outcome Measures

Primary Outcomes (1)

• Pain score

  Perceived pain will be assessed using a 100-point visual analog scale (VAS). The VAS ranges from 0 to 100 with the lower score indicating less pain and the higher score indicating greater pain.

  Pain will be assessed using a 100-point Visual Analog Scale (VAS) at multiple time points during and after the procedure (pre-procedure, with speculum placement, with tenaculum placement, immediately after uterine sound, immediately after IUD placement,

Secondary Outcomes (2)

• Satisfaction of Vibration Therapy

  15 minutes post-procedure

• Acceptability of Vibration Therapy

  15 minutes post-procedure

Study Arms (2)

Periumbilical Placement of Vibrating Device

EXPERIMENTAL

Participants assigned to this arm will have a handheld vibrating device placed at the umbilicus during intrauterine device insertion procedure.

Device: Periumbilical Vibration during Intrauterine Device Placement

Standard of Care

NO INTERVENTION

Participants assigned to this arm will not have a vibrating device placed at the umbilicus during intrauterine device placement. They will receive standard of care.

Interventions

Periumbilical Vibration during Intrauterine Device Placement DEVICE

Participants will be randomly assigned to receive a vibrating device placed on the belly button during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device.

Periumbilical Placement of Vibrating Device

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Capable of providing informed consent
• Scheduled for IUD insertion at either Duke 1J gynecology clinic or Family Planning clinic
• English-speaking

You may not qualify if:

• Currently pregnant
• Planned use of IV sedation during IUD placement
• Inability to provide informed consent due to disability or language barrier

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Related Publications (12)

• Mckenzie N, Barnhart K. (044) AN INNOVATIVE AND NON-INVASIVE METHOD OF REDUCING PAIN UTILIZING VIBRATION DURING IUD INSERTION: PATIENT REACTIONS AND ONE PROVIDER'S APPROACH. The Journal of Sexual Medicine. 2024;21(Supplement_5):qdae054.042. doi:10.1093/jsxmed/qdae054.042

  BACKGROUND

• Wu J, Lim S, Scott A, Hayes T, Unnithan S, Erkanli A, Havrilesky LJ, Swartz JJ. Transcutaneous Electric Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):e14-e23. doi: 10.1097/AOG.0000000000005727. Epub 2024 Nov 21.

  PMID: 39575620 BACKGROUND

• 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.

  PMID: 28079781 BACKGROUND

• Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.

  PMID: 34352845 BACKGROUND

• Hwang LK, Nash DW, Yedlin A, Greige N, Larios-Valencia J, Choice C, Pothula A. The Effect of Vibration on Pain During Intravenous Injection of Propofol: A Randomized Controlled Trial. Ann Plast Surg. 2021 Jul 1;87(1s Suppl 1):S36-S39. doi: 10.1097/SAP.0000000000002827.

  PMID: 33833179 BACKGROUND

• Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.

  PMID: 22134226 BACKGROUND

• Casale R, Hansson P. The analgesic effect of localized vibration: a systematic review. Part 1: the neurophysiological basis. Eur J Phys Rehabil Med. 2022 Apr;58(2):306-315. doi: 10.23736/S1973-9087.22.07415-9. Epub 2022 Feb 1.

  PMID: 35102735 BACKGROUND

• Dempsey A, Aucoin C, Stallings W, Kulangara A, Sundstrom B. Beyond pain medication: striving toward more patient-centered placement of intrauterine devices. Contraception. 2025 Aug;148:110944. doi: 10.1016/j.contraception.2025.110944. Epub 2025 May 8.

  PMID: 40348315 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.

  PMID: 38586685 BACKGROUND

• 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

• Lopes-Garcia EA, Carmona EV, Monteiro I, Bahamondes L. Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):163-167. doi: 10.1080/13625187.2023.2189500. Epub 2023 Mar 24.

  PMID: 36961099 BACKGROUND

• Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in the United States, 2014 and 2016. F S Rep. 2020 Jul 9;1(2):83-93. doi: 10.1016/j.xfre.2020.06.006. eCollection 2020 Sep.

  PMID: 34223223 BACKGROUND

Study Officials

• Beverly Gray, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline Thornton, MD, MPH

CONTACT

(919) 668- 2591; madeline.thornton@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)