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.