xml: <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/NCT05979012</url>
    </required_header>
    <id_info>
      <org_study_id>#3454</org_study_id>
      <nct_id>NCT05979012</nct_id>
    </id_info>
    <brief_title>Jazz Music and Mindfulness for Chronic Pain</brief_title>
    <official_title>Jazz Music and Mindfulness for Chronic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Irvine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Irvine</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chronic pain, including spinal pain and osteoarthritis, is the leading cause of years lived&#xD;
        with disability world-wide and the costliest health condition in the U.S. today. Compounding&#xD;
        these concerns, opioid analgesics remain the primary pharmacological treatment for chronic&#xD;
        pain. An estimated 21-29% of chronic pain patients receiving long-term opioid therapy develop&#xD;
        opioid misuse, and opioid misuse portends addiction and overdose. Clearly, chronic pain&#xD;
        patients need better, non-addictive treatment options designed to reverse the downward spiral&#xD;
        of chronic pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Group Assignments&#xD;
  &#xD;
        Participants will be randomized into one of three groups.&#xD;
  &#xD;
          1. Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation&#xD;
             video prior to the 4-week intervention.&#xD;
  &#xD;
          2. Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch a video on&#xD;
             mindful listening to jazz.&#xD;
  &#xD;
          3. Music Waitlist Group: Participants in this group will serve as a control and will not&#xD;
             receive any intervention until the study is completed. They will complete a baseline&#xD;
             survey and a follow-up survey at four weeks. Some videos will be sent to this group&#xD;
             after the study is completed, without tracking their usage.&#xD;
  &#xD;
        Intervention&#xD;
  &#xD;
        All groups will complete a baseline and 4-week follow-up survey.&#xD;
  &#xD;
        Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week&#xD;
        intervention.They will have access to electronic audio recordings, with the order of&#xD;
        listening labeled for each day. It is up to them if they want to listen to the daily&#xD;
        recordings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain Self-Efficacy</measure>
      <time_frame>4 weeks</time_frame>
      <description>Pain self-efficacy, which refers to participants' confidence in their ability to manage pain, will be assessed using the Pain Self-Efficacy Questionnaire.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Satisfaction with Treatment</measure>
      <time_frame>4 weeks</time_frame>
      <description>Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>4 weeks</time_frame>
      <description>The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Interference</measure>
      <time_frame>4 weeks</time_frame>
      <description>The degree of pain interference in different aspects of participants' lives will be evaluated using the PEG scale.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>Jazz Only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MIndfullness and Jazz</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch an introduction to jazz appreciation and mindfulness training video, including the use of jazz for pain tolerance prior to the 4-week intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Music Waitlist Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks. Some videos will be sent to this group after the study is completed, without tracking their usage.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MIndfulness Listening to Jazz</intervention_name>
      <description>All groups will complete a baseline and 4-week follow-up survey.&#xD;
  Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.It is up to them if they want to listen to the daily recordings.</description>
      <arm_group_label>MIndfullness and Jazz</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Listening to Jazz</intervention_name>
      <description>All groups will complete a baseline and 4-week follow-up survey.&#xD;
  Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. The recordings will increase gradually throughout the study, starting with about 10 minutes each day in the first week and reaching 30 minutes each day in the final week. The schedule is as follows: Week 1= 10 minutes, Week 2= 15 minutes, Week 3= 20 minutes Week 4= 30 minutes. It is up to them if they want to listen to the daily recordings.</description>
      <arm_group_label>Jazz Only</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Are 18+&#xD;
  &#xD;
            2. Live in the US&#xD;
  &#xD;
            3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed&#xD;
               on type)&#xD;
  &#xD;
            4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale&#xD;
               in the preceding week&#xD;
  &#xD;
            5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days&#xD;
  &#xD;
            6. Have moderate to severe anxiety based on GAD-7&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Are currently using or have used prescription opioids in the past 3 months to minimize&#xD;
               a known treatment confound and increase sample homogeneity&#xD;
  &#xD;
            2. Have a current cancer diagnosis&#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>University of California Irvine</name>
        <address>
          <city>Irvine</city>
          <state>California</state>
          <zip>92868</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Dominic Ugarte, MD</last_name>
        <email>dugarte@hs.uci.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Irvine</investigator_affiliation>
      <investigator_full_name>Sean D Young</investigator_full_name>
      <investigator_title>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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979012
  org study id: #3454
  nct id: NCT05979012
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Chronic pain, including spinal pain and osteoarthritis, is the leading cause of years lived
        with disability world-wide and the costliest health condition in the U.S. today. Compounding
        these concerns, opioid analgesics remain the primary pharmacological treatment for chronic
        pain. An estimated 21-29% of chronic pain patients receiving long-term opioid therapy develop
        opioid misuse, and opioid misuse portends addiction and overdose. Clearly, chronic pain
        patients need better, non-addictive treatment options designed to reverse the downward spiral
        of chronic pain.
  Group Assignments
  
        Participants will be randomized into one of three groups.
  
          1. Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation
             video prior to the 4-week intervention.
  
          2. Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch a video on
             mindful listening to jazz.
  
          3. Music Waitlist Group: Participants in this group will serve as a control and will not
             receive any intervention until the study is completed. They will complete a baseline
             survey and a follow-up survey at four weeks. Some videos will be sent to this group
             after the study is completed, without tracking their usage.
  
        Intervention
  
        All groups will complete a baseline and 4-week follow-up survey.
  
        Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week
        intervention.They will have access to electronic audio recordings, with the order of
        listening labeled for each day. It is up to them if they want to listen to the daily
        recordings.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain Self-Efficacy
  time frame: 4 weeks
  description: Pain self-efficacy, which refers to participants' confidence in their ability to manage pain, will be assessed using the Pain Self-Efficacy Questionnaire.
  measure: Global Satisfaction with Treatment
  time frame: 4 weeks
  description: Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale.
  measure: Pain Intensity
  time frame: 4 weeks
  description: The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week.
  measure: Pain Interference
  time frame: 4 weeks
  description: The degree of pain interference in different aspects of participants' lives will be evaluated using the PEG scale.
  arm group label: Jazz Only
  arm group type: Active Comparator
  description: Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention.
  arm group label: MIndfullness and Jazz
  arm group type: Experimental
  description: Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch an introduction to jazz appreciation and mindfulness training video, including the use of jazz for pain tolerance prior to the 4-week intervention.
  arm group label: Waitlist
  arm group type: No Intervention
  description: Music Waitlist Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks. Some videos will be sent to this group after the study is completed, without tracking their usage.
  intervention type: Behavioral
  intervention name: MIndfulness Listening to Jazz
  description: All groups will complete a baseline and 4-week follow-up survey.
  Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.It is up to them if they want to listen to the daily recordings.
  arm group label: MIndfullness and Jazz
  intervention type: Behavioral
  intervention name: Listening to Jazz
  description: All groups will complete a baseline and 4-week follow-up survey.
  Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. The recordings will increase gradually throughout the study, starting with about 10 minutes each day in the first week and reaching 30 minutes each day in the final week. The schedule is as follows: Week 1= 10 minutes, Week 2= 15 minutes, Week 3= 20 minutes Week 4= 30 minutes. It is up to them if they want to listen to the daily recordings.
  arm group label: Jazz Only
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Irvine
  investigator full name: Sean D Young
  investigator title: Professor
  mesh term: Chronic Pain