Weighted Blankets for Postsurgical Pain

University of California San Diego logo

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

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.

Trial contacts and locations

1

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Central trial contact

Laura K Case, PhD

Data sourced from clinicaltrials.gov

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