Weighted Blankets for Postsurgical Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Weighted Blankets on Perioperative Anxiety and Postsurgical Pain

Conditions
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Pain, Postsurgical

Intervention / Treatment
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* Device: Weighted blanket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heavier blanket<br>A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants. | Device: Weighted blanket<br>* A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.<br>|
| Experimental: Lighter blanket<br>A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants. | Device: Weighted blanket<br>* A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.<br>|
| No Intervention: Waitlist control<br>No blanket will be provided until the end of the study; participants will sleep with their normal bedding. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postsurgical pain from before to after overnight blanket use | 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 | baseline, 1 week, 1 month, and 3 months | 
| Change in medication use from before to after overnight blanket use | Medications taken in past 24 hours will be self-reported | baseline, 1 week, 1 month, and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastectomy, anxiety, blankets