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| ID | Type | Description | Link |
|---|---|---|---|
| A532014 | Other Identifier | UW Madison | |
| Protocol Version 6/5/2024 | Other Identifier | UW Madison |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorazepam administration prior to IUD insertion procedure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorazepam 1 mg | Drug | 1 mg oral lorazepam, a sedative used to relieve anxiety |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for Pain | Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain). | 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). | before and after the procedure (up to 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Scores for Nulliparous and Multiparous Participants | Comparison of mean pain scores between participants that have never had childbirth to those who have. | before and after the procedure (up to 1 hour) |
| Mean Anxiety Scores for Nulliparous and Multiparous Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jensena Carlson, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Family Medicine Residency Clinics | Madison | Wisconsin | 53715 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Ibuprofen 800 mg | Drug | 800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain |
|
Comparison of mean anxiety scores between participants that have never had childbirth to those who have. |
| before and after the procedure (up to 1 hour) |
| Number of Participants Recruited | Feasibility will in part be measured with recruitment rates. | 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. | 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. | up to 2 months (estimated time period of recruitment) |
| 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. | post-procedure (up to 1 hour) |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |