Weighted Blankets for Postsurgical Pain

University of California San Diego

Status: Enrolling

Conditions: Pain, Postsurgical

Treatments: Device: Weighted blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT05324254

210487

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 3 patient groups

Heavier blanket

Experimental group

Description:

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

Treatment:

Device: Weighted blanket

Lighter blanket

Experimental group

Description:

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

Treatment:

Device: Weighted blanket

Waitlist control

No Intervention group

Description:

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