Weighted Blankets for Postsurgical Pain

Not Applicable

Recruiting

• Conditions: Pain, Postsurgical
• Interventions: Device: Weighted blanket

• Registration Number: NCT05324254
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Study Start: 2022-10-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lighter blanket	Weighted blanket	A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Heavier blanket	Weighted blanket	A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

Primary Outcome Measures

Name	Time	Method
Change in anxiety ratings from before to during blanket use before surgery	arrival to surgical center and final rating prior to surgery	Anxiety ratings will be compared before and during use of weighted blanket on the following scale: "Extremely anxious" to "Neutral" to "Extremely calm"
Change in postsurgical pain from before to after overnight blanket use	baseline (before surgery) and 1 and 3 months after surgery	Brief Pain Inventory score will be compared before and after overnight use of assigned blanket
Change in medication use from before to after overnight blanket use	baseline (before surgery) and 1 and 3 months after surgery	Medications taken in past 24 hours will be self-reported

Secondary Outcome Measures

Name	Time	Method
Change in medication use from before to after overnight blanket use	baseline, 1 week, 1 month, and 3 months	Medications taken in past 24 hours will be self-reported
Change in postsurgical pain from before to after overnight blanket use	baseline, 1 week, 1 month, and 3 months	Pain ratings will be compared before and after overnight use of assigned blanket: Pain Intensity visual analog scale "No pain" to "Most intense pain imaginable" and Pain unpleasantness visual analog scale: "No unpleasantness" to "Most unpleasant pain imaginable"

Trial Locations

Locations (1)

Actri, Ucsd; 🇺🇸 La Jolla, California, United States