No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
168 (estimated)
Sponsor
University of California, San Diego · Other
Who this trial is looking for
This trial is looking for people who are having breast surgery and want to see if using a weighted blanket can help reduce their anxiety before surgery and pain after surgery. Participants will need to use the blanket for up to 3 months and will share their experiences through an app on their smartphone.
Are You a Good Fit for This Trial?
You may be able to join if
I am fluent in English
I am undergoing breast surgery
I can sleep with a weighted blanket for up to 3 months
I have a BMI of at least 18.5 and can safely lift up to 15 pounds
I can use my smartphone to send updates through an app
You may not be able to join if
I am pregnant
I use high-dose opioids regularly
I have used a weighted blanket before
I have claustrophobia
I am currently incarcerated
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 change…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 ratin…
Inclusion Criteria:
* 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
Exclusion Criteria:
* Pregnancy
* Chronic high-dose opioid use
* Current or previous use of a weighted blanket
* Claustrophobia
* Incarceration
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