<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447885</url>
  </required_header>
  <id_info>
    <org_study_id>200628</org_study_id>
    <nct_id>NCT04447885</nct_id>
  </id_info>
  <brief_title>Weighted Blankets and Chronic Pain</brief_title>
  <official_title>Weighted Blankets and Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test whether the use of weighted blankets can change the&#xD;
      experience of chronic pain and to examine if social, psychological, or health factors&#xD;
      influence the perception of the blanket. Multiple blanket weights will be tested.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">November 25, 2020</completion_date>
  <primary_completion_date type="Actual">November 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain ratings from before to after brief blanket use</measure>
    <time_frame>0 and 15 minutes</time_frame>
    <description>Pain ratings will be compared before and after use of weighted blanket on the following scale: Pain VAS: &quot;No pain&quot; to &quot;Worst pain ever&quot; (higher = worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain ratings from before to after nightly blanket use</measure>
    <time_frame>at baseline (3 nights) and over 7 nights of use</time_frame>
    <description>Pain ratings will be compared before and after 1 week of nightly use of weighted blanket on the following scale: Pain VAS: &quot;No pain&quot; to &quot;Worst pain ever&quot; (higher = worse).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety ratings from before to after brief blanket use</measure>
    <time_frame>0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use</time_frame>
    <description>Anxiety ratings will be compared before and after use of weighted blanket on the following scale: Anxiety VAS: &quot;Extremely anxious&quot; to &quot;Neutral&quot; to &quot;Extremely calm&quot; (higher = better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ratings of sleep quality from before to after brief blanket use</measure>
    <time_frame>baseline (3 nights) and over 7 nights of use</time_frame>
    <description>Change in sleep quality from before to after use of weighted blanket will be compared on the following scale: perceived sleep quality VAS: &quot;Extremely poor&quot; to &quot;Neutral&quot; to &quot;Extremely good&quot; (higher = better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality measured by fitness watch from before to during week of blanket use</measure>
    <time_frame>baseline (3 nights) and over 7 nights of use</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Chronic Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Experimental blanket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This blanket is the weight being tested which cannot be disclosed without unblinding participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control blanket</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This blanket is the control weight which cannot be disclosed without unblinding participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>weighted blanket</intervention_name>
    <description>A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.</description>
    <arm_group_label>Control blanket</arm_group_label>
    <arm_group_label>Experimental blanket</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years or older&#xD;
&#xD;
          2. Fluent in English&#xD;
&#xD;
          3. Diagnosis of chronic pain (self-report; those already indicating this diagnosis on&#xD;
             researchmatch.org)&#xD;
&#xD;
          4. Willing to sleep with a weighted blanket and fitness watch for 1 week&#xD;
&#xD;
          5. Able to safely lift up to 15lb&#xD;
&#xD;
          6. Willing and able to use their personal smartphone for fitness tracker app and EMA app&#xD;
             to submit ratings using personal data plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Major medical conditions such as kidney, liver, cardiovascular (hypertension,&#xD;
             preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g.,&#xD;
             seizure disorder)&#xD;
&#xD;
          3. Current or previous use of a weighted blanket&#xD;
&#xD;
          4. Claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Laura Case</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447885
org study id: 200628
nct id: NCT04447885
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in pain ratings from before to after brief blanket use
time frame: 0 and 15 minutes
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).
measure: Change in pain ratings from before to after nightly blanket use
time frame: at baseline (3 nights) and over 7 nights of 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).
measure: 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
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).
measure: Change in ratings of sleep quality from before to after brief blanket use
time frame: baseline (3 nights) and over 7 nights of 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).
measure: 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
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.
arm group label: Experimental blanket
arm group type: Experimental
description: This blanket is the weight being tested which cannot be disclosed without unblinding participants.
arm group label: Control blanket
arm group type: Active Comparator
description: This blanket is the control weight which cannot be disclosed without unblinding participants.
intervention type: Device
intervention name: weighted blanket
description: A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
arm group label: Control blanket
arm group label: Experimental blanket
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Laura Case
investigator title: Assistant Professor
mesh term: Chronic Pain
sharing ipd: No