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/NCT05981924</url>
    </required_header>
    <id_info>
      <org_study_id>A2023-003</org_study_id>
      <nct_id>NCT05981924</nct_id>
    </id_info>
    <brief_title>Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery</brief_title>
    <official_title>A Phase II Study of Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hao Long</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sun Yat-sen University School of Art</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sun Yat-sen University Department of Psychology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sun Yat-sen University</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>
        To explore the feasibility and effectiveness of Perioperative Music Therapy Plus Oxycodone in&#xD;
        pain management after thoracic surgery, patients will be randomly assigned into two groups.&#xD;
        The experimental group will receive perioperative music therapy and the control group will&#xD;
        not. We will record and contrast the postoperative oxycodone usage to evaluate the effect of&#xD;
        music therapy in relieving the pain. We will also use visual analogue scale, questionnaire&#xD;
        and EEG to evaluate patients' anxiety and depression.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>Patients will be randomly assigned into two groups, the experimental group will receive music therapy and oxycodone for the pain management after thoracic surgery. The control group will only use oxycodone to relief the pain.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The total dose of oxycodone within 72 hours after surgery</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>The total dose of oxycodone within 72 hours after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The VSA-A Score</measure>
      <time_frame>1 day before surgery, 1 hour before surgery, 24/48/72 hours after surgery</time_frame>
      <description>The Visual Analogue Scale-Anxiety Score at different observation point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The VSA-P Score</measure>
      <time_frame>24/48/72 hours after surgery</time_frame>
      <description>The Visual Analogue Scale-Pain Score at different observation point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence rate of analgesic related adverse reaction</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>The incidence rate of analgesic related adverse reaction within 72 hours after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The usage of extra analgesics after surgery</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The kind and usage of anesthetics for anesthesia induction and maintenance</measure>
      <time_frame>During the surgery</time_frame>
      <description>The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Analgesia</condition>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Oxycodone with Perioperative Music Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Using perioperative music therapy plus oxycodone to manage the postoperative pain</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Oxycodone without Perioperative Music Therapy</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Using oxycodone only to manage the postoperative pain</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Perioperative Music Therapy</intervention_name>
      <description>Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia</description>
      <arm_group_label>Oxycodone with Perioperative Music Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Enhanced CT or PET/CT indicate primary malignant pulmonary nodule;&#xD;
  &#xD;
            -  The clinical stage belongs to cT1-4N0-2M0 before treatment or ycT1-4N0-2M0 after&#xD;
               neoadjuvant treatment (AJCC/TNM 8th Edition);&#xD;
  &#xD;
            -  Suitable for video-assisted thoracoscopic surgery after evaluated by thoracic surgeon;&#xD;
  &#xD;
            -  FEV1 &gt; 1.5L and DLCO &gt; 60% pred;&#xD;
  &#xD;
            -  Hearing loss lesser than 35 decibels (dB) in the better hearing ear;&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;&#xD;
  &#xD;
            -  American Society of Anesthesiologists Score of 1 or 2;&#xD;
  &#xD;
            -  Confirmed eligibility for R0 resection for curative intent by thoracic surgeon&#xD;
               assessment;&#xD;
  &#xD;
            -  Adequate cardiopulmonary function, confirmed to meet the requirement for surgical&#xD;
               resection for curative intent;&#xD;
  &#xD;
            -  Able to provide written informed consent and able to understand and agree to comply&#xD;
               with study requirements and evaluation forms;&#xD;
  &#xD;
            -  Life expectancy greater than 12 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Enhanced CT or PET/CT indicate metastatic malignant pulmonary nodule;&#xD;
  &#xD;
            -  Hearing loss greater than 35 decibels (dB) in the better hearing ear;&#xD;
  &#xD;
            -  Active autoimmune disease or history of autoimmune disease that may recur; Note:&#xD;
               well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid&#xD;
               hormone replacement only); well-controlled celiac disease; skin disease not requiring&#xD;
               systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is&#xD;
               not expected to recur in the absence of an external trigger.&#xD;
  &#xD;
            -  History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases,&#xD;
               including diabetes, hypertension, pulmonary fibrosis, acute lung disease;&#xD;
  &#xD;
            -  Serious infection occurred before grouping, including but not limited to&#xD;
               hospitalization due to infectious complications, bacteremia or severe pneumonia;&#xD;
               severe chronic or active infection (including pulmonary tuberculosis infection, etc.)&#xD;
               requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;&#xD;
  &#xD;
            -  Simultaneous participation in another therapeutic clinical study;&#xD;
  &#xD;
            -  Pregnant or lactating women, or male and female patients planning to have children&#xD;
               during the study;&#xD;
  &#xD;
            -  Other conditions that the investigators consider inappropriate for participation in&#xD;
               this trial, such as poor compliance.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hao Long, MD</last_name>
      <phone>+86-20-87343314</phone>
      <email>longhao@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Center</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hao Long, MD</last_name>
        <phone>+86-20-87343261</phone>
        <email>longhao@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17.</citation>
      <PMID>26282640</PMID>
    </reference>
    <results_reference>
      <citation>Zhou W, Ye C, Wang H, Mao Y, Zhang W, Liu A, Yang CL, Li T, Hayashi L, Zhao W, Chen L, Liu Y, Tao W, Zhang Z. Sound induces analgesia through corticothalamic circuits. Science. 2022 Jul 8;377(6602):198-204. doi: 10.1126/science.abn4663. Epub 2022 Jul 7.</citation>
      <PMID>35857536</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Hao Long</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <keyword>Music Therapy</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Quality of Life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Agnosia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05981924
  org study id: A2023-003
  nct id: NCT05981924
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To explore the feasibility and effectiveness of Perioperative Music Therapy Plus Oxycodone in
        pain management after thoracic surgery, patients will be randomly assigned into two groups.
        The experimental group will receive perioperative music therapy and the control group will
        not. We will record and contrast the postoperative oxycodone usage to evaluate the effect of
        music therapy in relieving the pain. We will also use visual analogue scale, questionnaire
        and EEG to evaluate patients' anxiety and depression.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomly assigned into two groups, the experimental group will receive music therapy and oxycodone for the pain management after thoracic surgery. The control group will only use oxycodone to relief the pain.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The total dose of oxycodone within 72 hours after surgery
  time frame: 72 hours after surgery
  description: The total dose of oxycodone within 72 hours after surgery
  measure: The VSA-A Score
  time frame: 1 day before surgery, 1 hour before surgery, 24/48/72 hours after surgery
  description: The Visual Analogue Scale-Anxiety Score at different observation point
  measure: The VSA-P Score
  time frame: 24/48/72 hours after surgery
  description: The Visual Analogue Scale-Pain Score at different observation point
  measure: The incidence rate of analgesic related adverse reaction
  time frame: 72 hours after surgery
  description: The incidence rate of analgesic related adverse reaction within 72 hours after surgery
  measure: The usage of extra analgesics after surgery
  time frame: 72 hours after surgery
  description: The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine
  measure: The kind and usage of anesthetics for anesthesia induction and maintenance
  time frame: During the surgery
  description: The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium
  arm group label: Oxycodone with Perioperative Music Therapy
  arm group type: Experimental
  description: Using perioperative music therapy plus oxycodone to manage the postoperative pain
  arm group label: Oxycodone without Perioperative Music Therapy
  arm group type: No Intervention
  description: Using oxycodone only to manage the postoperative pain
  intervention type: Other
  intervention name: Perioperative Music Therapy
  description: Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia
  arm group label: Oxycodone with Perioperative Music Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hao Long, MD
  phone: +86-20-87343314
  email: longhao@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17.
  PMID: 26282640
  citation: Zhou W, Ye C, Wang H, Mao Y, Zhang W, Liu A, Yang CL, Li T, Hayashi L, Zhao W, Chen L, Liu Y, Tao W, Zhang Z. Sound induces analgesia through corticothalamic circuits. Science. 2022 Jul 8;377(6602):198-204. doi: 10.1126/science.abn4663. Epub 2022 Jul 7.
  PMID: 35857536
  responsible party type: Sponsor-Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Hao Long
  investigator title: Prof.
  mesh term: Agnosia
  sharing ipd: No