Weighted Blankets for Post-Surgical Pain
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using high-dose opioids, you may not be eligible to participate.
What data supports the effectiveness of the treatment Weighted Blanket for post-surgical pain?
While there is no direct research on weighted blankets for post-surgical pain, studies show that relaxation techniques, like music and jaw relaxation, can help reduce pain after surgery. These methods, similar to the calming effect of a weighted blanket, suggest that such treatments might also help manage post-surgical pain.12345
How does the treatment of using weighted blankets for post-surgical pain differ from other treatments?
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for English-speaking individuals scheduled for breast surgery, with a BMI of at least 18.5 and the strength to lift up to 15 pounds. They must be willing to sleep with a weighted blanket for up to three months and use their smartphone to submit data. Pregnant individuals, chronic high-dose opioid users, current/previous weighted blanket users, those with claustrophobia or who are incarcerated cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use either a heavier or lighter blanket overnight for 3 months to assess changes in anxiety and postsurgical pain
Follow-up
Participants are monitored for changes in anxiety and pain levels after the treatment period
Treatment Details
Interventions
- Weighted Blanket
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor