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Weighted Blankets and Chronic Pain

Primary Purpose

Chronic Pain, Chronic Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weighted blanket
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental blanket

Control blanket

Arm Description

This blanket is the weight being tested which cannot be disclosed without unblinding participants.

This blanket is the control weight which cannot be disclosed without unblinding participants.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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).
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.

Full Information

First Posted
June 18, 2020
Last Updated
April 26, 2021
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04447885
Brief Title
Weighted Blankets and Chronic Pain
Official Title
Weighted Blankets and Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Chronic Pain Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental blanket
Arm Type
Experimental
Arm Description
This blanket is the weight being tested which cannot be disclosed without unblinding participants.
Arm Title
Control blanket
Arm Type
Active Comparator
Arm Description
This blanket is the control weight which cannot be disclosed without unblinding participants.
Intervention Type
Device
Intervention Name(s)
weighted blanket
Intervention Description
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Primary Outcome Measure Information:
Title
Change in pain ratings from before to after brief blanket use
Description
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).
Time Frame
0 and 15 minutes
Title
Change in pain ratings from before to after nightly blanket use
Description
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).
Time Frame
at baseline (3 nights) and over 7 nights of use
Secondary Outcome Measure Information:
Title
Change in anxiety ratings from before to after brief blanket use
Description
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).
Time Frame
0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use
Title
Change in ratings of sleep quality from before to after brief blanket use
Description
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).
Time Frame
baseline (3 nights) and over 7 nights of use
Title
Change in sleep quality measured by fitness watch from before to during week of blanket use
Description
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.
Time Frame
baseline (3 nights) and over 7 nights of use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Fluent in English Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org) Willing to sleep with a weighted blanket and fitness watch for 1 week Able to safely lift up to 15lb Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan Exclusion Criteria: Pregnancy Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) Current or previous use of a weighted blanket Claustrophobia
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34425251
Citation
Baumgartner JN, Quintana D, Leija L, Schuster NM, Bruno KA, Castellanos JP, Case LK. Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. J Pain. 2022 Jan;23(1):156-174. doi: 10.1016/j.jpain.2021.07.009. Epub 2021 Aug 20.
Results Reference
derived

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Weighted Blankets and Chronic Pain

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