To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
73
Cervical stabilization device that uses vacuum
standard of care cervical stabilization device
Indiana University Hospital
Indianapolis, Indiana, United States
Patient-perceived Pain
Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Provider-perceived Bleeding
Bleeding perceived by the provider during and after the procedure.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Provider-perceived Ease of Use
Providers will report their perceived ease of use with the Carevix device indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Provider-perceived Satisfaction
Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
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