TENS Unit for Analgesia During IUD Insertion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-50
SponsorTufts Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Persons with a uterus desiring insertion of intrauterine device

Able to provide informed consent/assent

Age 12-50 years old

Minors 12 years of age and older will be included in the study if postmenarchal

Disqualifiers

Unable to provide informed consent/assent

Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)

Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)

Cutaneous damage at the TENS electrode sites

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Paracervical block only or participant declines analgesia for IUD insertion

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: TENS unitExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self reported pain intensity from participants during IUD insertion

Survey responses

Time frame
Day 1

Secondary outcomes

1

Pain at other time points during IUD insertion procedure

Survey responses

Time frame
Day 1
2

Rate of vasovagal responses

Participant observation

Time frame
Day 1
3

Likelihood to recommend pain management regiment to a friend for same procedure

Survey responses

Time frame
Day 1

Other outcomes

Sponsors and contacts

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