Weighted Blankets and Chronic Pain

Study Overview
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Brief Summary
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The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.

Official Title
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Weighted Blankets and Chronic Pain

Conditions
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Chronic Pain, Chronic Pain Syndrome

Intervention / Treatment
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* Device: weighted blanket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Fluent in English Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org) Willing to sleep with a weighted blanket and fitness watch for 1 week Able to safely lift up to 15lb Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan Exclusion Criteria: Pregnancy Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) Current or previous use of a weighted blanket Claustrophobia

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental blanket<br>This blanket is the weight being tested which 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>|
| Active Comparator: Control blanket<br>This blanket is the control weight which 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain ratings from before to after brief blanket use | Pain ratings will be compared before and after use of weighted blanket on the following scale: Pain VAS: No pain to Worst pain ever (higher = worse). | 0 and 15 minutes | 
| Change in pain ratings from before to after nightly blanket use | Pain ratings will be compared before and after 1 week of nightly use of weighted blanket on the following scale: Pain VAS: No pain to Worst pain ever (higher = worse). | at baseline (3 nights) and over 7 nights of use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety ratings from before to after brief blanket use | Anxiety ratings will be compared before and after use of weighted blanket on the following scale: Anxiety VAS: Extremely anxious to Neutral to Extremely calm (higher = better). | 0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use | 
| Change in ratings of sleep quality from before to after brief blanket use | Change in sleep quality from before to after use of weighted blanket will be compared on the following scale: perceived sleep quality VAS: Extremely poor to Neutral to Extremely good (higher = better). | baseline (3 nights) and over 7 nights of use | 
| Change in sleep quality measured by fitness watch from before to during week of blanket use | Change in sleep quality from before to during use of weighted blanket will be compared by measurement of deep vs light sleep from a fitness watch. | baseline (3 nights) and over 7 nights of use |