Recruiting

Weighted Blankets

Sponsor:

UCLA

Code:

NCT05324254

Conditions

Pain, Postsurgical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Weighted blanket

Study Details

Brief 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.

Conditions

Pain, Postsurgical

Study ID

NCT05324254

Start date

Oct 1, 2022

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Heavier blanket

A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

experimental: Lighter blanket

A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

no intervention: Waitlist control

No blanket will be provided until the end of the study; participants will sleep with their normal bedding.

Interventions

Weighted blanket

A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

Primary outcome measure

  • Change in anxiety ratings from before to during blanket use before surgery [ Time Frame: arrival to surgical center and final rating prior to surgery ]
  • Change in postsurgical pain from before to after overnight blanket use [ Time Frame: baseline (before surgery) and 1 and 3 months after surgery ]
  • Change in medication use from before to after overnight blanket use [ Time Frame: baseline (before surgery) and 1 and 3 months after surgery ]

Central Contacts and Locations

Central contacts

Laura K Case, PhD

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

Locations

Actri, Ucsd

Recruiting

La Jolla, California, United States, 92093

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • mastectomy
  • anxiety
  • blankets

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-04-28.