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/NCT05979103</url>
    </required_header>
    <id_info>
      <org_study_id>#3585</org_study_id>
      <nct_id>NCT05979103</nct_id>
    </id_info>
    <brief_title>Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients</brief_title>
    <official_title>Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients</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>
      <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>
        Social psychological research has demonstrated that internalized stereotypes affect people's&#xD;
        attitudes and behaviors. Music-based interventions that rely on stereotypes might have&#xD;
        promise for keeping participants engaged in health interventions, reducing stress, and&#xD;
        improving wellbeing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Group Assignments&#xD;
  &#xD;
        Participants will be randomized into one of three groups.&#xD;
  &#xD;
          1. Group 1 (Reggae): Participants in this group will receive the stereotype and listen to&#xD;
             the music over the 4 weeks.&#xD;
  &#xD;
          2. Group 2 (Nature): Participants in this group will listen to nature sounds over the 4&#xD;
             weeks.&#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 recordings 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 Group 1 and Group 2 will engage in daily listening 4-week intervention.They&#xD;
        will have access to electronic audio recordings, with the order of listening labeled for each&#xD;
        day. It is up to them if they want to listen to the daily recordings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>GAD-7 Score</measure>
      <time_frame>4 weeks</time_frame>
      <description>Anxiety levels will be evaluated using the General Anxiety Disorder (GAD-7) 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 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>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Reggae Music</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1 (Reggae): Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nature Sounds</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 2 (Nature): Participants in this group will listen to nature sounds over the 4 weeks and will not be told any stereotypes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist Group</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 recordings 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>Listening to Reggae Music and told the stereotype</intervention_name>
      <description>Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks. Each day, we will send them a playlist to listen to.</description>
      <arm_group_label>Reggae Music</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Listening to Nature Sounds</intervention_name>
      <description>Participants in this group will NOT be told the stereotype for the audio they are listening to. They will listen to nature sounds over the 4 weeks. Each day, we will send them a playlist to listen to.</description>
      <arm_group_label>Nature Sounds</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/NCT05979103
  org study id: #3585
  nct id: NCT05979103
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Social psychological research has demonstrated that internalized stereotypes affect people's
        attitudes and behaviors. Music-based interventions that rely on stereotypes might have
        promise for keeping participants engaged in health interventions, reducing stress, and
        improving wellbeing.
  Group Assignments
  
        Participants will be randomized into one of three groups.
  
          1. Group 1 (Reggae): Participants in this group will receive the stereotype and listen to
             the music over the 4 weeks.
  
          2. Group 2 (Nature): Participants in this group will listen to nature sounds over the 4
             weeks.
  
          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 recordings 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 Group 1 and 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: GAD-7 Score
  time frame: 4 weeks
  description: Anxiety levels will be evaluated using the General Anxiety Disorder (GAD-7) 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 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.
  arm group label: Reggae Music
  arm group type: Experimental
  description: Group 1 (Reggae): Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks.
  arm group label: Nature Sounds
  arm group type: Active Comparator
  description: Group 2 (Nature): Participants in this group will listen to nature sounds over the 4 weeks and will not be told any stereotypes.
  arm group label: Waitlist Group
  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 recordings will be sent to this group after the study is completed, without tracking their usage.
  intervention type: Behavioral
  intervention name: Listening to Reggae Music and told the stereotype
  description: Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks. Each day, we will send them a playlist to listen to.
  arm group label: Reggae Music
  intervention type: Behavioral
  intervention name: Listening to Nature Sounds
  description: Participants in this group will NOT be told the stereotype for the audio they are listening to. They will listen to nature sounds over the 4 weeks. Each day, we will send them a playlist to listen to.
  arm group label: Nature Sounds
  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