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/NCT05974384</url>
    </required_header>
    <id_info>
      <org_study_id>Music Radio</org_study_id>
      <nct_id>NCT05974384</nct_id>
    </id_info>
    <brief_title>Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.</brief_title>
    <official_title>Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management: A Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Corporacion Parc Tauli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Corporacion Parc Tauli</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Fractures of the distal end of the radius are one of the most frequent fractures diagnosed in&#xD;
        the emergency room. The initial management, and in many cases definitive, is carried out&#xD;
        through manipulation, closed reduction and immobilization in the emergency room. Different&#xD;
        methods of anesthesia have been described to reduce pain during the manipulation and&#xD;
        reduction procedure, such as: hematoma block, periosteal block, general anesthesia,&#xD;
        intravenous regional anesthesia, nitrous oxide, intramuscular sedation, and conscious&#xD;
        sedation. Despite the use of different methods of anesthesia, none is fully effective and&#xD;
        each of these methods is not free of complications. Adjuvant measures could play an important&#xD;
        role in improving the patient's experience during the procedure, however, there is little&#xD;
        evidence in this regard.&#xD;
  &#xD;
        Music is increasingly being studied and developed as an adjunctive therapy in the management&#xD;
        of pain and anxiety in different medical procedures, demonstrating a statistically&#xD;
        significant reduction in pain and anxiety. However, in the literature there is no evidence of&#xD;
        studies that evaluate the effect of music during the reduction of fractures in traumatology&#xD;
        as an adjuvant therapy for the management of pain and anxiety.&#xD;
  &#xD;
        In our experience, despite the anesthesia used, reductions of distal radius fractures are&#xD;
        usually a painful procedure that involves a certain degree of discomfort for the patient. For&#xD;
        this reason, the investigators believe this study is necessary, as it could demonstrate a new&#xD;
        adjuvant therapy that reduces pain and anxiety and improves the overall experience of the&#xD;
        patient, in addition to being music, a low-cost tool with no risks for patient safety.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>Supportive Care</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in VAS scale for pain</measure>
      <time_frame>Will be completed just after the fracture immobilization</time_frame>
      <description>It will be completed after the procedure and the punctuation will go from 0 to 10</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Anxiety STAI-6</measure>
      <time_frame>Done just before and after the pfracture immobilization</time_frame>
      <description>Puntuation between 20 and 80, 50 considered high anxiety level</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cardiac frequency</measure>
      <time_frame>Will be assessed just before, during and after the fracture imobilization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Will be assessed just before, during and after the fracture imobilization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction after procedure</measure>
      <time_frame>Just after the immobilization, when patient will be discharged</time_frame>
      <description>1 to 5 scale for satisfaction with the procedure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Distal Radius Fracture Reduction</condition>
    <arm_group>
      <arm_group_label>No Music</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Intervention without music</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Music</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intervention while listening to music</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>No Music</intervention_name>
      <description>No listening to music while intervention is carried out</description>
      <arm_group_label>No Music</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Music</intervention_name>
      <description>Listening to music while intervention is carried out</description>
      <arm_group_label>Music</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 18 years.&#xD;
  &#xD;
            -  Clinical and radiological diagnosis of a fracture of the distal end of a closed radius&#xD;
               that has an indication for closed reduction.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of other concomitant fractures.&#xD;
  &#xD;
            -  Allergy to local anesthetics.&#xD;
  &#xD;
            -  Significant hearing impairment and/or use of hearing aids.&#xD;
  &#xD;
            -  Patients whose comorbidities prevent correct participation in the procedure (such as&#xD;
               cognitive impairment, diagnosis of psychiatric diseases, patients under the influence&#xD;
               of drugs...).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Enrique Cueva, Doctor</last_name>
      <phone>937 23 10 10</phone>
      <phone_ext>21660</phone_ext>
      <email>enrique.cueva.sevieri@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mireia Viñas, Doctor</last_name>
      <phone>937 23 10 10</phone>
      <phone_ext>21660</phone_ext>
      <email>mmvinas@tauli.cat</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Parc Taulí</name>
        <address>
          <city>Sabadell</city>
          <state>Barcelona</state>
          <zip>08208</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mireia</last_name>
        <phone>21660</phone>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Chhabra AB, Yildirim B. Adult Distal Radius Fracture Management. J Am Acad Orthop Surg. 2021 Nov 15;29(22):e1105-e1116. doi: 10.5435/JAAOS-D-20-01335.</citation>
      <PMID>34288886</PMID>
    </reference>
    <reference>
      <citation>Tabrizi A, Mirza Tolouei F, Hassani E, Taleb H, Elmi A. Hematoma Block Versus General Anesthesia in Distal Radius Fractures in Patients Over 60 Years in Trauma Emergency. Anesth Pain Med. 2016 Nov 27;7(1):e40619. doi: 10.5812/aapm.40619. eCollection 2017 Feb.</citation>
      <PMID>28920036</PMID>
    </reference>
    <reference>
      <citation>Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19. Erratum In: J Music Ther. 2021 Aug 24;58(3):372.</citation>
      <PMID>27760797</PMID>
    </reference>
    <reference>
      <citation>Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernandez F, Guerra-Farfan E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9. Erratum In: Trials. 2020 Sep 30;21(1):821.</citation>
      <PMID>32787892</PMID>
    </reference>
    <reference>
      <citation>Low S, Papay M, Eingartner C. Pain Perception following Initial Closed Reduction in the Preoperative Care of Unstable, Dorsally Displaced Distal Radius Fractures. J Hand Microsurg. 2019 Aug;11(2):111-116. doi: 10.1055/s-0039-1688681. Epub 2019 May 26.</citation>
      <PMID>31413496</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
      <investigator_full_name>Heber Enrique Cueva Sevieri</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Radius Fractures</mesh_term>
      <mesh_term>Wrist Fractures</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/NCT05974384
  org study id: Music Radio
  nct id: NCT05974384
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Fractures of the distal end of the radius are one of the most frequent fractures diagnosed in
        the emergency room. The initial management, and in many cases definitive, is carried out
        through manipulation, closed reduction and immobilization in the emergency room. Different
        methods of anesthesia have been described to reduce pain during the manipulation and
        reduction procedure, such as: hematoma block, periosteal block, general anesthesia,
        intravenous regional anesthesia, nitrous oxide, intramuscular sedation, and conscious
        sedation. Despite the use of different methods of anesthesia, none is fully effective and
        each of these methods is not free of complications. Adjuvant measures could play an important
        role in improving the patient's experience during the procedure, however, there is little
        evidence in this regard.
  
        Music is increasingly being studied and developed as an adjunctive therapy in the management
        of pain and anxiety in different medical procedures, demonstrating a statistically
        significant reduction in pain and anxiety. However, in the literature there is no evidence of
        studies that evaluate the effect of music during the reduction of fractures in traumatology
        as an adjuvant therapy for the management of pain and anxiety.
  
        In our experience, despite the anesthesia used, reductions of distal radius fractures are
        usually a painful procedure that involves a certain degree of discomfort for the patient. For
        this reason, the investigators believe this study is necessary, as it could demonstrate a new
        adjuvant therapy that reduces pain and anxiety and improves the overall experience of the
        patient, in addition to being music, a low-cost tool with no risks for patient safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Investigator)
  measure: Change in VAS scale for pain
  time frame: Will be completed just after the fracture immobilization
  description: It will be completed after the procedure and the punctuation will go from 0 to 10
  measure: Change in Anxiety STAI-6
  time frame: Done just before and after the pfracture immobilization
  description: Puntuation between 20 and 80, 50 considered high anxiety level
  measure: Cardiac frequency
  time frame: Will be assessed just before, during and after the fracture imobilization
  measure: Blood pressure
  time frame: Will be assessed just before, during and after the fracture imobilization
  measure: Satisfaction after procedure
  time frame: Just after the immobilization, when patient will be discharged
  description: 1 to 5 scale for satisfaction with the procedure
  arm group label: No Music
  arm group type: Placebo Comparator
  description: Intervention without music
  arm group label: Music
  arm group type: Active Comparator
  description: Intervention while listening to music
  intervention type: Device
  intervention name: No Music
  description: No listening to music while intervention is carried out
  arm group label: No Music
  intervention type: Device
  intervention name: Music
  description: Listening to music while intervention is carried out
  arm group label: Music
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Enrique Cueva, Doctor
  phone: 937 23 10 10
  phone ext: 21660
  email: enrique.cueva.sevieri@gmail.com
  last name: Mireia Viñas, Doctor
  phone: 937 23 10 10
  phone ext: 21660
  email: mmvinas@tauli.cat
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  citation: Chhabra AB, Yildirim B. Adult Distal Radius Fracture Management. J Am Acad Orthop Surg. 2021 Nov 15;29(22):e1105-e1116. doi: 10.5435/JAAOS-D-20-01335.
  PMID: 34288886
  citation: Tabrizi A, Mirza Tolouei F, Hassani E, Taleb H, Elmi A. Hematoma Block Versus General Anesthesia in Distal Radius Fractures in Patients Over 60 Years in Trauma Emergency. Anesth Pain Med. 2016 Nov 27;7(1):e40619. doi: 10.5812/aapm.40619. eCollection 2017 Feb.
  PMID: 28920036
  citation: Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19. Erratum In: J Music Ther. 2021 Aug 24;58(3):372.
  PMID: 27760797
  citation: Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernandez F, Guerra-Farfan E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9. Erratum In: Trials. 2020 Sep 30;21(1):821.
  PMID: 32787892
  citation: Low S, Papay M, Eingartner C. Pain Perception following Initial Closed Reduction in the Preoperative Care of Unstable, Dorsally Displaced Distal Radius Fractures. J Hand Microsurg. 2019 Aug;11(2):111-116. doi: 10.1055/s-0039-1688681. Epub 2019 May 26.
  PMID: 31413496
  responsible party type: Principal Investigator
  investigator affiliation: Corporacion Parc Tauli
  investigator full name: Heber Enrique Cueva Sevieri
  investigator title: Doctor
  mesh term: Fractures, Bone
  mesh term: Radius Fractures
  mesh term: Wrist Fractures
  sharing ipd: No