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Intrauterine Device PlacementNCT07714590

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

A study testing Periumbilical Vibration during Intrauterine Device Placement in people with Intrauterine Device Placement, run by Duke University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Intrauterine Device Placement
What is being tested?
Periumbilical Vibration during Intrauterine Device Placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteUnited States
Study dates
9 Oct 2026to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Madeline Thornton, MD, MPH contact

(919) 668- 2591

madeline.thornton@duke.edu

United States1 site, 1 recruiting

  • Duke University Hospital

    Durham, North Carolina, 27705

    Beverly Gray, MD, (919) 668- 2591, beverly.gray@duke.edu

    Kristin Weaver, 919-681-0308, kristin.weaver@duke.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Periumbilical Vibration during Intrauterine Device Placement
Keywords
intrauterine device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periumbilical Vibration during Intrauterine Device PlacementDevice

    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.

Study groups in NCT07714590
Study groupRoleWhat they receive
Periumbilical Placement of Vibrating DeviceExperimentalParticipants assigned to this arm will have a handheld vibrating device placed at the umbilicus during intrauterine device insertion procedure.
Receives: Device: Periumbilical Vibration during Intrauterine Device Placement
Standard of CareNo interventionParticipants assigned to this arm will not have a vibrating device placed at the umbilicus during intrauterine device placement. They will receive standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Satisfaction of Vibration Therapy

    Participants in the intervention arm will complete a post-procedure questionnaire evaluating satisfaction with the vibration therapy.

    Measured: 15 minutes post-procedure

  2. Acceptability of Vibration Therapy

    Participants in the intervention arm will complete a post-procedure questionnaire evaluating acceptability of the vibration therapy.

    Measured: 15 minutes post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study start9 Oct 2026
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07714590
Sponsor's protocol ID
Pro00118748
Other IDs
391001436
Status last verified
Oct 2026
First submitted
15 Jul 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 39575620

  • 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.

    PubMed 28079781

  • 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.

    PubMed 34352845

  • 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.

    PubMed 33833179

  • 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.

    PubMed 22134226

  • 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.

    PubMed 35102735

  • 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.

    PubMed 40348315

  • 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.

    PubMed 38586685

  • 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.

    PubMed 31882291

  • 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.

    PubMed 36961099

  • 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.

    PubMed 34223223

Questions about this trial

What is this clinical trial studying?

A study testing Periumbilical Vibration during Intrauterine Device Placement in people with Intrauterine Device Placement, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Madeline Thornton, MD, MPH ((919) 668- 2591, madeline.thornton@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: 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,). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07714590, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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