Heavier blanket for Post-surgical Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Post-surgical PainWeighted blanket - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Post-surgical Pain

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: baseline, 1 week, 1 month, and 3 months

arrival to surgical center and final rating prior to surgery
Change in anxiety ratings from before to during blanket use before surgery
Month 3
Change in medication use from before to after overnight blanket use
Pain

Trial Safety

Trial Design

3 Treatment Groups

Waitlist control
1 of 3
Heavier blanket
1 of 3
Lighter blanket
1 of 3

Active Control

Experimental Treatment

168 Total Participants · 3 Treatment Groups

Primary Treatment: Heavier blanket · No Placebo Group · N/A

Heavier blanket
Device
Experimental Group · 1 Intervention: Weighted blanket · Intervention Types: Device
Lighter blanket
Device
Experimental Group · 1 Intervention: Weighted blanket · Intervention Types: Device
Waitlist controlNoIntervention Group · 1 Intervention: Waitlist control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weighted blanket
2018
N/A
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 week, 1 month, and 3 months

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,029 Previous Clinical Trials
1,806,234 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to speak English fluently.\n
You have undergone breast surgery.\n
You are willing to sleep with a weighted blanket for up to 3 months.
You are willing and able to use your personal smartphone for the ecological momentary assessment app to submit ratings using personal data plan.