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Weighted Blankets and Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447885
Recruitment Status : Enrolling by invitation
First Posted : June 25, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Laura Case, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Chronic Pain Syndrome Device: weighted blanket Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : June 4, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in pain ratings from before to after brief blanket use [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447885


Locations
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United States, California
UC San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Laura Case, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04447885    
Other Study ID Numbers: 200628
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations