TENS Unit for Analgesia During IUD Insertion

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT06240260
Status
Recruiting
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Conditions

  • Analgesia
  • IUD
  • Pain, Acute
  • Patient Preference

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • TENS (transcutaneous electrical nerve stimulation) unit — DEVICE
    Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of a mild electrical current. A TENS machine is a small, battery-operated device that has leads connected to sticky pads called electrodes.
  • Standard care — OTHER
    Paracervical block only or participant declines analgesia for IUD insertion

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: TENS unit
    Patients who choose to use a TENS unit for their IUD insertion procedure
  • Active Comparator: Standard care
    Patients who decline to use a TENS unit for their IUD insertion procedure

Primary Outcome Measure

Self reported pain intensity from participants during IUD insertion [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Alysa St. Charles, MA
[email protected]
617-636-9897
Andrea Zuckerman, MD (PRINCIPAL_INVESTIGATOR)
Caitie McCarthy, MD (SUB_INVESTIGATOR)
Danielle Roncari, MD (SUB_INVESTIGATOR)

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