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The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental blanket | Experimental | This blanket is the weight being tested which cannot be disclosed without unblinding participants. |
|
| Control blanket | Active Comparator | This blanket is the control weight which cannot be disclosed without unblinding participants. |
|
| 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 pain ratings from before to after brief blanket use | Pain ratings will be compared before and after use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse). | 0 and 15 minutes |
| Change in pain ratings from before to after nightly blanket use | Pain ratings will be compared before and after 1 week of nightly use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse). | at baseline (3 nights) and over 7 nights of use |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety ratings from before to after brief blanket use | Anxiety ratings will be compared before and after use of weighted blanket on the following scale: Anxiety VAS: "Extremely anxious" to "Neutral" to "Extremely calm" (higher = better). | 0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34425251 | Derived | Baumgartner JN, Quintana D, Leija L, Schuster NM, Bruno KA, Castellanos JP, Case LK. Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. J Pain. 2022 Jan;23(1):156-174. doi: 10.1016/j.jpain.2021.07.009. Epub 2021 Aug 20. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change in ratings of sleep quality from before to after brief blanket use |
Change in sleep quality from before to after use of weighted blanket will be compared on the following scale: perceived sleep quality VAS: "Extremely poor" to "Neutral" to "Extremely good" (higher = better). |
| baseline (3 nights) and over 7 nights of use |
| Change in sleep quality measured by fitness watch from before to during week of blanket use | Change in sleep quality from before to during use of weighted blanket will be compared by measurement of deep vs light sleep from a fitness watch. | baseline (3 nights) and over 7 nights of use |