Clinical trial NCT06496854: Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study
Official title: Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pain
IUD
Keywords: IUD insertion
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Participants who undergo IUD insertion and complete the visual analogue scales to rate their anxiety and pain level prior to the procedure and after the procedure.
* Participants must have a driver take them to their appointment if they take lorazepam prior to their arrival at the clinic.
* Participants must have a driver take them home after the procedure as well.
* Participants must consent to email communication since they will sign the consent forms electronically

Exclusion Criteria:

* Participants who do not show up for their appointment.
* Participants who receive cervical blocks or other analgesic method during IUD insertion.
* Participants who have a history of substance use disorder.
* Participants who are taking medications with a central nervous system (CNS) depressant effect (ex: opioids, benzodiazepines).
* Participants who are not able to sign an electronic consent form.
* Participants who do not have a driver to take them to their appointment and to take them home after the procedure.
* Participants who do not agree to sign consent forms electronically.

Primary outcomes:
measure: Visual Analogue Scale for Pain
timeFrame: before and after the procedure (up to 1 hour)
measure: Visual Analogue Scale for Anxiety
timeFrame: before and after the procedure (up to 1 hour)
Secondary outcomes:
measure: Mean Pain Scores for Nulliparous and Multiparous Participants
timeFrame: before and after the procedure (up to 1 hour)
measure: Mean Anxiety Scores for Nulliparous and Multiparous Participants
timeFrame: before and after the procedure (up to 1 hour)
measure: Number of Participants Recruited
timeFrame: up to 2 months (estimated time period of recruitment)
measure: Number of Participants with lorazepam prescription adherence
timeFrame: up to 2 months (estimated time period of recruitment)
measure: Number of Participants Who Completed All Surveys
timeFrame: up to 2 months (estimated time period of recruitment)
measure: Qualitative Measure: Participant Experience
timeFrame: post-procedure (up to 1 hour)
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Family Medicine Residency Clinics
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Jensena Carlson, MD
role: PRINCIPAL_INVESTIGATOR
References: