Weighted Blankets and Chronic Pain

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 30, 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Experimental blanket
    • This blanket is the weight being tested which cannot be disclosed without unblinding participants.
  • Active Comparator: Control blanket
    • This blanket is the control weight which cannot be disclosed without unblinding participants.

Clinical Trial Outcome Measures

Primary Measures

  • Change in pain ratings from before to after brief blanket use
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Change in anxiety ratings from before to after brief blanket use
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laura Case, Assistant Professor – University of California, San Diego

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