Chronic Pain, Chronic Pain Syndrome
Conditions
Brief summary
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.
Interventions
DEVICEweighted blanket
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Fluent in English 3. Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org) 4. Willing to sleep with a weighted blanket and fitness watch for 1 week 5. Able to safely lift up to 15lb 6. Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan
Exclusion criteria
1. Pregnancy 2. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) 3. Current or previous use of a weighted blanket 4. Claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain ratings from before to after brief blanket use | 0 and 15 minutes | 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). |
| Change in pain ratings from before to after nightly blanket use | at baseline (3 nights) and over 7 nights of 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety ratings from before to after brief blanket use | 0 and 15 minutes; also at baseline (3 nights) and over 7 nights of 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). |
| Change in ratings of sleep quality from before to after brief blanket use | baseline (3 nights) and over 7 nights of 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). |
| Change in sleep quality measured by fitness watch from before to during week of blanket use | baseline (3 nights) and over 7 nights of 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. |
Countries
United States
Outcome results
None listed