Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496854
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Prescribing Lorazepam for IUD Insertion Pilot Feasibility Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Prescribing Lorazepam for IUD Insertion Pilot Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants experiences with taking lorazepam and participating in the study
Assess investigators experience with the trial via a focus group
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 participants experiences with taking lorazepam and participating in the study
Assess investigators experience with the trial via a focus group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A532014 | OTHER | None | None |
| Protocol Version 652024 | OTHER | None | None |