The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.
The purpose of the research is to evaluate the feasibility of prescribing lorazepam and measuring its effect on anxiety and pain with IUD insertion. The descriptive data from this study will be used to offer guidance for how to implement a larger scale study in the future. Primary endpoint: Assess preliminary differences in pain and anxiety scores pre-IUD insertion and post-IUD insertion using a Mann-Whitney U test. Participants will score their anxiety and pain levels pre-procedure and post-procedure using a 10cm visual analogue scale. This will be a one arm trial where all subjects will receive 1mg lorazepam and 800mg ibuprofen prior to the procedure. Secondary endpoints * Discuss if there was a difference in pain and anxiety scores among nulliparous (no previous childbirths) and multiparous (one or more previous childbirths) participants. * Summarize recruitment rates, adherence to lorazepam prescription, completion rates of questionnaires and scales * Discuss participant's experiences with taking lorazepam and participating in the study * Assess investigator's experience with the trial via a focus group
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
1 mg oral lorazepam, a sedative used to relieve anxiety
800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain
UW Family Medicine Residency Clinics
Madison, Wisconsin, United States
Visual Analogue Scale for Pain
Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain).
Time frame: before and after the procedure (up to 1 hour)
Visual Analogue Scale for Anxiety
Participant will be asked to rate their anxiety on a scale of 0 (no anxiety) to 10 (severe anxiety).
Time frame: before and after the procedure (up to 1 hour)
Mean Pain Scores for Nulliparous and Multiparous Participants
Comparison of mean pain scores between participants that have never had childbirth to those who have.
Time frame: before and after the procedure (up to 1 hour)
Mean Anxiety Scores for Nulliparous and Multiparous Participants
Comparison of mean anxiety scores between participants that have never had childbirth to those who have.
Time frame: before and after the procedure (up to 1 hour)
Number of Participants Recruited
Feasibility will in part be measured with recruitment rates.
Time frame: up to 2 months (estimated time period of recruitment)
Number of Participants with lorazepam prescription adherence
Feasibility will in part be measured with adherence rates.
Time frame: up to 2 months (estimated time period of recruitment)
Number of Participants Who Completed All Surveys
Feasibility will in part be measured with survey completion rates.
Time frame: up to 2 months (estimated time period of recruitment)
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Qualitative Measure: Participant Experience
Participants will be asked questions about their experience taking lorazepam and to provide feedback about the study. Participant answers will be coded and themed to report as participant counts.
Time frame: post-procedure (up to 1 hour)