Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Periumbilical Vibration during Intrauterine Device Placement.
- Who it may be relevant to
- Registry conditions: Intrauterine Device Placement. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Periumbilical Vibration during Intrauterine Device Placement
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.
Primary outcome measures
- 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,]
Secondary outcome measures (2)
- Satisfaction of Vibration Therapy [Time frame: 15 minutes post-procedure]
- Acceptability of Vibration Therapy [Time frame: 15 minutes post-procedure]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Currently pregnant
- Planned use of IV sedation during IUD placement
- Inability to provide informed consent due to disability or language barrier
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Hospital — Durham
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 40348315
Identifiers
NCT: NCT07714590 · Pro00118748 · 391001436