An interventional study of Weighted blanket in Pain, Postsurgical, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 168 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Device: Weighted blanket
A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Device: Weighted blanket
No blanket will be provided until the end of the study; participants will sleep with their normal bedding.
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
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"
Time frame: 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
Time frame: 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
Time frame: baseline (before surgery) and 1 and 3 months after surgery
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"
Time frame: baseline, 1 week, 1 month, and 3 months
Change in medication use from before to after overnight blanket use
Medications taken in past 24 hours will be self-reported
Time frame: baseline, 1 week, 1 month, and 3 months
Plan to share: No
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University of California, San Diego