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TENS Unit for Analgesia During IUD Insertion

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025 Completion date: Jan 31, 2025 to Dec 31, 2025v3 Show 1 more changeShow less
    • Completion date: Jan 31, 2025 to Dec 31, 2025
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 31, 2024 to Dec 31, 2024 · Completion date: Sep 1, 2024 to Jan 31, 2025 · Secondary endpoints: details revised at 3 of 3 entries · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Jul 31, 2024 to Dec 31, 2024
    • Completion date: Sep 1, 2024 to Jan 31, 2025
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06240260
Lead Sponsor Tufts Medical Center
Conditions IUD, Analgesia, Patient Preference, Pain, Acute
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov