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The strongest psychological predictor of persistent pain after surgery is anxiety before surgery. The weight of blanket a person uses overnight may alter both anxiety and pain levels. The proposed study will determine whether a heavier or lighter blanket alters presurgical anxiety or postsurgical pain in individuals undergoing a breast surgery. We will also study whether any blanket-induced changes in postsurgical pain are related to reductions in anxiety before surgery induced by the blanket. Finally, we will examine clinical and psychological factors that might explain differences in how surgical patients respond to blanket weight. This research will improve our understanding of whether blanket weight can alter anxiety before a surgery or pain after a surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heavier blanket | Experimental | A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants. |
|
| Lighter blanket | Experimental | A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants. |
|
| Waitlist control | No Intervention | No blanket will be provided until the end of the study; participants will sleep with their normal bedding. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weighted blanket | Device | A weighted blanket is a blanket with extra weight sewn in for added pressure to the body. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety ratings from before to during blanket use before surgery | Anxiety ratings will be compared before and during use of weighted blanket on the following scale: "Extremely anxious" to "Neutral" to "Extremely calm" | arrival to surgical center and final rating prior to surgery |
| Change in postsurgical pain from before to after overnight blanket use | Brief Pain Inventory score will be compared before and after overnight use of assigned blanket | baseline (before surgery) and 1 and 3 months after surgery |
| Change in medication use from before to after overnight blanket use | Medications taken in past 24 hours will be self-reported | baseline (before surgery) and 1 and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postsurgical pain from before to after overnight blanket use | Pain ratings will be compared before and after overnight use of assigned blanket: Pain Intensity visual analog scale "No pain" to "Most intense pain imaginable" and Pain unpleasantness visual analog scale: "No unpleasantness" to "Most unpleasant pain imaginable" | baseline, 1 week, 1 month, and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura K Case, PhD | Contact | 858-246-4968 | lcase@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Actri, Ucsd | Recruiting | La Jolla | California | 92093 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Partial masking: Although blanket heaviness will be perceived, blanket weights tested in the study will not be disclosed to participants. Wait-list control group will know they are not receiving active intervention.
| Change in medication use from before to after overnight blanket use | Medications taken in past 24 hours will be self-reported | baseline, 1 week, 1 month, and 3 months |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |