Weighted Blankets and Chronic Pain

NCT04447885 | Completed

• 1 other identifier: 200628
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• 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 measured by fitness watch from before to during week of blanket use

  baseline (3 nights) and over 7 nights of use

Study Arms (2)

Experimental blanket

EXPERIMENTAL

This blanket is the weight being tested which cannot be disclosed without unblinding participants.

Device: weighted blanket

Control blanket

ACTIVE COMPARATOR

This blanket is the control weight which cannot be disclosed without unblinding participants.

Device: weighted blanket

Interventions

weighted blanket DEVICE

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

Control blanket; Experimental blanket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• 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.

  PMID: 34425251 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 25, 2020
• Study Start: June 4, 2020
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)