Weighted Blankets and Chronic Pain

Chronic Pain Clinical Trial

Official title:

Weighted Blankets and Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447885
• Other study ID #: 200628
• Status: Completed
• Phase: N/A
• Start date: June 4, 2020
• Est. completion date: November 25, 2020

Study information

• Verified date: April 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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