RecruitingNot ApplicableNCT06240260

TENS Unit for Analgesia During IUD Insertion

Utilization of Transcutaneous Electrical Nerve Stimulation (TENS) Unit for Analgesia During IUD Insertion: A Prospective Cohort Study


Sponsor

Tufts Medical Center

Enrollment

40 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 12 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard care and a medical device called TENS (transcutaneous electrical nerve stimulation) unit for people with analgesia, iud, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETENS (transcutaneous electrical nerve stimulation) unit

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.

OTHERStandard care

Paracervical block only or participant declines analgesia for IUD insertion


Locations(1)

Tufts Medical Center

Boston, Massachusetts, United States

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NCT06240260


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