Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial
19. august 2026 opdateret af: Duke University
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
114
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Madeline Thornton, MD, MPH
- Telefonnummer: (919) 668- 2591
- E-mail: madeline.thornton@duke.edu
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27705
- Duke University Hospital
-
Kontakt:
- Beverly Gray, MD
- Telefonnummer: (919) 668- 2591
- E-mail: beverly.gray@duke.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Periumbilical Placement of Vibrating Device
Participants assigned to this arm will have a handheld vibrating device placed at the umbilicus during intrauterine device insertion procedure.
|
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.
|
|
Ingen indgriben: Standard of Care
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain score
Tidsramme: 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,
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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.
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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,
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Satisfaction of Vibration Therapy
Tidsramme: 15 minutes post-procedure
|
Participants in the intervention arm will complete a post-procedure questionnaire evaluating satisfaction with the vibration therapy.
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15 minutes post-procedure
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Acceptability of Vibration Therapy
Tidsramme: 15 minutes post-procedure
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Participants in the intervention arm will complete a post-procedure questionnaire evaluating acceptability of the vibration therapy.
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15 minutes post-procedure
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Beverly Gray, MD, Duke Health
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
1. juli 2027
Datoer for studieregistrering
Først indsendt
15. juli 2026
Først indsendt, der opfyldte QC-kriterier
15. juli 2026
Først opslået (Faktiske)
20. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Pro00118748
- 391001436 (Andet bevillings-/finansieringsnummer: Charles B. Hammond Fund)
Plan for individuelle deltagerdata (IPD)
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