Weighted Blankets and Chronic Pain

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT04447885
• Collaborator: (none)
• Enrollment: 133
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 23.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Chronic Pain Syndrome	Device: weighted blanket	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Weighted Blankets and Chronic Pain
• Actual Study Start Date: Jun 4, 2020
• Actual Primary Completion Date: Nov 25, 2020
• Actual Study Completion Date: Nov 25, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

Secondary Outcome Measures

1. 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).

2. 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).

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC San Diego	La Jolla	California	United States	92093

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Case, Assistant Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT04447885
• Other Study ID Numbers: 200628
• First Posted: Jun 25, 2020
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Apr 27, 2021