What this study is
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.
What's being tested
- Weighted blanket
Intervention · DEVICE
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Study details
- Official title
- Effect of Weighted Blankets on Perioperative Anxiety and Postsurgical Pain
- Sponsor
- University of California, San Diego
- Conditions
- Pain, Postsurgical
- Enrolling
- 168 people
- Starts
- 2022-10-01
- Est. completion
- 2027-05
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Fluent in English
- Undergoing breast surgery
- Willing to sleep with a weighted blanket for up to 3 months
- BMI of at least 18.5 and able to safely lift up to 15lb
- Willing and able to use their personal smartphone for the ecological momentary assessment app to submit ratings using personal data plan
You can't join if
- Pregnancy
- Chronic high-dose opioid use
- Current or previous use of a weighted blanket
- Claustrophobia
- Incarceration
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openActri, Ucsd
La Jolla, California, United States
- Laura Case · Contact
Recruiting
Study team
Sponsor
University of California, San Diego
Study ID 210487
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.