Weighted Blankets and Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain; Chronic Pain Syndrome
• Interventions: Device: weighted blanket

• Registration Number: NCT04447885
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-04
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Primary Completion: 2020-11-25
• Study Completion: 2020-11-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental blanket	weighted blanket	This blanket is the weight being tested which cannot be disclosed without unblinding participants.
Control blanket	weighted blanket	This blanket is the control weight which cannot be disclosed without unblinding participants.

Primary Outcome Measures

Name	Time	Method
Change in pain ratings from before to after nightly blanket use	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).
Change in pain ratings from before to after brief blanket use	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).

Secondary Outcome Measures

Name	Time	Method
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	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	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	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.

Trial Locations

Locations (1)

UC San Diego; 🇺🇸 La Jolla, California, United States