Weighted Blankets and Chronic Pain

University of California, San Diego133 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

133

Conditions

Chronic Pain Chronic Pain Syndrome

Interventions

weighted blanketDEVICE

A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UC San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: at baseline (3 nights) and over 7 nights of use

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: baseline (3 nights) and over 7 nights of use

Data from ClinicalTrials.gov

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