Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
168 participants
INTERVENTIONAL
2022-10-01
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Heavier blanket
A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Weighted blanket
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Lighter blanket
A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Weighted blanket
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Waitlist control
No blanket will be provided until the end of the study; participants will sleep with their normal bedding.
No interventions assigned to this group
Interventions
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Weighted blanket
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Chronic high-dose opioid use
* Current or previous use of a weighted blanket
* Claustrophobia
* Incarceration
18 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Laura Case
Adjunct Professor
Locations
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Actri, Ucsd
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Laura Case
Role: primary
Other Identifiers
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210487
Identifier Type: -
Identifier Source: org_study_id
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