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/NCT06032897</url>
    </required_header>
    <id_info>
      <org_study_id>KMUHIRB-SV(Ⅰ)-20220050</org_study_id>
      <nct_id>NCT06032897</nct_id>
    </id_info>
    <brief_title>Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study</brief_title>
    <official_title>The Effect of Personalized Music on the Elderly With Cognitive Impairment and Dementia: a Quasi-experimental Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</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>
        This pilot study was designed to evaluate the effects of Individualized music listening (IML)&#xD;
        implemented on older adults with mild cognitive impairment (MCI) and PwD. This&#xD;
        quasi-experimental study used convenience sampling where thirty-two elderly individuals were&#xD;
        recruited from five community-based dementia care centers then assigned to experimental (EG,&#xD;
        n = 16) or control (CG, n = 16) groups according to the self-reports of importance of music&#xD;
        in their lives and according to their personal wishes. The EG received eight treatments of&#xD;
        IML (two times per week, 20 minutes per time), while the CG received the usual activities of&#xD;
        the care centers for four weeks when EG received IML. The anxiety levels of both groups were&#xD;
        investigated before and after first time IML and after eighth time IML. The researcher&#xD;
        observed positive and negative behaviors of EG before, during and after each IML per 20&#xD;
        minutes in each time IML.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 25, 2022</start_date>
    <completion_date type="Actual">July 3, 2023</completion_date>
    <primary_completion_date type="Actual">January 5, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety</measure>
      <time_frame>First day: before the first time individualized music listening; first day: after completing first-time individualized music listeningof 20 minutes; the fourth week: after the last (eighth) time Individualized music listening of 20 minutes.</time_frame>
      <description>The Chinese Mandarin version State-Trait Anxiety Inventory Y form. The scores of the 20 questions are summed with total score ranging from 20 to 80 points. The higher the total score, the higher the anxiety level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Behavioral</measure>
      <time_frame>Four weeks: eight times of individualized music listening. Before 20 minutes, during 20 minute, after 20 minute of every time individualized music listening.</time_frame>
      <description>The Behavioral Observation Form for Intervention Condition checklist. If the 15 behaviors occurred in each period (20 minutes), the behavior column will be counted as 1 point in this time period, and if there were no behavior, it would be scored as 0 points. In this study, 15 behaviors were further classified into positive and negative behaviors (four negative behaviors included eye movement, agitation/restlessness, alertness, and sleeping), and then the scores of the two types of behaviors were summed up and the total score represented the performances of the behavior type. Higher scores mean more the type.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">32</enrollment>
    <condition>Music Listening</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group who participated in routine activities</description>
    </arm_group>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The individualized music listening were performed twice a week for four weeks, for a total of eight times.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Individualized music listening (IML)</intervention_name>
      <description>The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The Individualized music listening (IML) were performed twice a week for four weeks, for a total of eight times.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 50 years or older;&#xD;
  &#xD;
            2. Mild cognitive impairment or dementia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Can not answer questions by themselves;&#xD;
  &#xD;
            2. Have the habit of listening music in the past week.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pei-Chao Lin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kaohsiung Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kaohsiung Medical University</name>
        <address>
          <city>Kaohsiung</city>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dementia</keyword>
    <keyword>individualized music listening</keyword>
    <keyword>anxiety</keyword>
    <keyword>behavior</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</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/NCT06032897
  org study id: KMUHIRB-SV(Ⅰ)-20220050
  nct id: NCT06032897
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This pilot study was designed to evaluate the effects of Individualized music listening (IML)
        implemented on older adults with mild cognitive impairment (MCI) and PwD. This
        quasi-experimental study used convenience sampling where thirty-two elderly individuals were
        recruited from five community-based dementia care centers then assigned to experimental (EG,
        n = 16) or control (CG, n = 16) groups according to the self-reports of importance of music
        in their lives and according to their personal wishes. The EG received eight treatments of
        IML (two times per week, 20 minutes per time), while the CG received the usual activities of
        the care centers for four weeks when EG received IML. The anxiety levels of both groups were
        investigated before and after first time IML and after eighth time IML. The researcher
        observed positive and negative behaviors of EG before, during and after each IML per 20
        minutes in each time IML.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Anxiety
  time frame: First day: before the first time individualized music listening; first day: after completing first-time individualized music listeningof 20 minutes; the fourth week: after the last (eighth) time Individualized music listening of 20 minutes.
  description: The Chinese Mandarin version State-Trait Anxiety Inventory Y form. The scores of the 20 questions are summed with total score ranging from 20 to 80 points. The higher the total score, the higher the anxiety level.
  measure: Behavioral
  time frame: Four weeks: eight times of individualized music listening. Before 20 minutes, during 20 minute, after 20 minute of every time individualized music listening.
  description: The Behavioral Observation Form for Intervention Condition checklist. If the 15 behaviors occurred in each period (20 minutes), the behavior column will be counted as 1 point in this time period, and if there were no behavior, it would be scored as 0 points. In this study, 15 behaviors were further classified into positive and negative behaviors (four negative behaviors included eye movement, agitation/restlessness, alertness, and sleeping), and then the scores of the two types of behaviors were summed up and the total score represented the performances of the behavior type. Higher scores mean more the type.
  arm group label: control group
  arm group type: No Intervention
  description: The control group who participated in routine activities
  arm group label: experimental group
  arm group type: Experimental
  description: The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The individualized music listening were performed twice a week for four weeks, for a total of eight times.
  intervention type: Other
  intervention name: Individualized music listening (IML)
  description: The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The Individualized music listening (IML) were performed twice a week for four weeks, for a total of eight times.
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pei-Chao Lin
  role: Principal Investigator
  affiliation: Kaohsiung Medical University
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Dementia