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Weighted Blankets for Post-Surgical Pain

N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing breast surgery
Willing and able to use their personal smartphone for the ecological momentary assessment app to submit ratings using personal data plan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 1 month, and 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trialwill study how blanket weight can affect anxiety & pain before & after breast surgery, and if it can help explain differences in how surgical patients respond.

Who is the study for?
This trial is for English-speaking individuals scheduled for breast surgery, with a BMI of at least 18.5 and the strength to lift up to 15 pounds. They must be willing to sleep with a weighted blanket for up to three months and use their smartphone to submit data. Pregnant individuals, chronic high-dose opioid users, current/previous weighted blanket users, those with claustrophobia or who are incarcerated cannot participate.
What is being tested?
The study is testing if using heavier or lighter blankets before surgery can reduce anxiety and post-surgical pain in patients undergoing breast surgery. It will also explore how these potential changes in pain relate to pre-surgery anxiety levels and identify factors that influence patient responses.
What are the potential side effects?
There may not be typical 'side effects' as seen with medications; however, participants might experience discomfort due to the weight of the blanket or issues related to claustrophobia despite being screened out if they have severe cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for breast surgery.
Select...
I can use my smartphone and data plan for the study's app.
Select...
My BMI is over 18.5 and I can safely lift 15 pounds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 1 month, and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 1 month, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in anxiety ratings from before to during blanket use before surgery
Secondary study objectives
Change in medication use from before to after overnight blanket use
Pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Lighter blanketExperimental Treatment1 Intervention
A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Group II: Heavier blanketExperimental Treatment1 Intervention
A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Group III: Waitlist controlActive Control1 Intervention
No blanket will be provided until the end of the study; participants will sleep with their normal bedding.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weighted blanket
2018
N/A
~30

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,879 Total Patients Enrolled

Media Library

Heavier blanket Clinical Trial Eligibility Overview. Trial Name: NCT05324254 — N/A
Surgical Pain Research Study Groups: Heavier blanket, Lighter blanket, Waitlist control
Surgical Pain Clinical Trial 2023: Heavier blanket Highlights & Side Effects. Trial Name: NCT05324254 — N/A
Heavier blanket 2023 Treatment Timeline for Medical Study. Trial Name: NCT05324254 — N/A
~66 spots leftby May 2026
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