RecruitingNot Applicable

Weighted Blankets for Postsurgical Pain

United States168 participantsStarted 2022-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in anxiety ratings from before to during blanket use before surgery

Timeframe: arrival to surgical center and final rating prior to surgery

Change in postsurgical pain from before to after overnight blanket use

Timeframe: baseline (before surgery) and 1 and 3 months after surgery

Change in medication use from before to after overnight blanket use

Timeframe: baseline (before surgery) and 1 and 3 months after surgery

Trial details

NCT IDNCT05324254

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Laura K Case, PhD

858-246-4968 lcase@health.ucsd.edu

View on ClinicalTrials.gov More Pain, Postsurgical trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in anxiety ratings from before to during blanket use before surgery

Timeframe: arrival to surgical center and final rating prior to surgery

Change in postsurgical pain from before to after overnight blanket use

Timeframe: baseline (before surgery) and 1 and 3 months after surgery

Change in medication use from before to after overnight blanket use

Timeframe: baseline (before surgery) and 1 and 3 months after surgery