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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

Tracking Information
First Submitted Date  ICMJE June 18, 2020
First Posted Date  ICMJE June 25, 2020
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE June 4, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weighted Blankets and Chronic Pain
Official Title  ICMJE Weighted Blankets and Chronic Pain
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Chronic Pain
  • Chronic Pain Syndrome
Intervention  ICMJE Device: weighted blanket
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Study Arms  ICMJE
  • Experimental: Experimental blanket
    This blanket is the weight being tested which cannot be disclosed without unblinding participants.
    Intervention: Device: weighted blanket
  • Active Comparator: Control blanket
    This blanket is the control weight which cannot be disclosed without unblinding participants.
    Intervention: Device: weighted blanket
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 22, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04447885
Other Study ID Numbers  ICMJE 200628
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura Case, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP