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When having an intrauterine device placed in an outpatient clinic, patients frequently feel anxiety related to the procedure. This study is designed to determine if the use of a small, weighted blanket, placed over the patient's chest and shoulders, would help decrease that anxiety, as well as pain related to the procedure.
Patients scheduled for an IUD placement in this specific outpatient clinic will be approached by the study nurse to gauge interest in participating. Consented patients will be randomized to either receive a weighted blanket or a non-weighted blanket. Patients will rate their anxiety on a 100 mm visual-analog scale and pain on a 0-10 verbal scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weighted blanket | Experimental | A weighted blanket will be applied to the patient during IUD placement |
|
| Non-weighted blanket | Sham Comparator | A non-weighted light blanket will be applied to patient during IUD insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10-pound weighted lap-pad | Other | 10-pound weighted lap pad will be placed over the patient's chest and shoulders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale - Anxiety | Patients will make a mark on a 100 mm line to indicate level of anxiety | At the conclusion of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Guastello, BSN | Saint Luke's Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31882291 | Background | Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| blanket | Other | A simple, unweighted blanket will be applied to patients during IUD insertion |
|