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OpenTrials
Completed

NCT Number: NCT04447885

Weighted Blankets and Chronic Pain

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.

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Key information

Conditions

Chronic Pain Chronic Pain Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weighted blanket

Device

A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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