Weighted Blankets and Chronic Pain

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 Overview

• Status: Completed
• Conditions: Chronic Pain; Chronic Pain Syndrome
• Intervention / Treatment: Device: weighted blanket

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental blanket; This blanket is the weight being tested which cannot be disclosed without unblinding participants.	Device: weighted blanket; A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Active Comparator: Control blanket; This blanket is the control weight which cannot be disclosed without unblinding participants.	Device: weighted blanket; A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• Baumgartner JN, Quintana D, Leija L, Schuster NM, Bruno KA, Castellanos JP, Case LK. Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. J Pain. 2022 Jan;23(1):156-174. doi: 10.1016/j.jpain.2021.07.009. Epub 2021 Aug 20.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): November 25, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 200628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No