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/NCT05980845</url>
    </required_header>
    <id_info>
      <org_study_id>12.09.2018-4</org_study_id>
      <nct_id>NCT05980845</nct_id>
    </id_info>
    <brief_title>The Effect Nature Sounds and Music on Hemodialysis Patients</brief_title>
    <official_title>The Effect of Nature Sounds and Music on Vital Signs and Anxiety Levels of Hemodialysis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mehmet Akif Ersoy University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mehmet Akif Ersoy University</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>
        The study was conducted as a randomized controlled experimental research to examine the&#xD;
        effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients.&#xD;
  &#xD;
        The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who&#xD;
        received treatment in the hemodialysis units of three hospitals, one university, one&#xD;
        education research and one state hospital in Antalya province, met the inclusion criteria and&#xD;
        consented to participate in the study. Patients were homogenously divided into intervention&#xD;
        (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age,&#xD;
        gender and hemodialysis duration. Patients in the intervention group were subjected to nature&#xD;
        sounds/music during the hemodialysis procedure, while patients in the control group were not&#xD;
        subjected to any intervention during the procedure. The data were collected by face-to-face&#xD;
        interview technique using the &quot;Descriptive Characteristics Form&quot;, &quot;Vital Signs Monitoring&#xD;
        Form&quot;, &quot;State Anxiety Inventory&quot; and &quot;Trait Anxiety Inventory&quot;. Ethics committee approval,&#xD;
        institutional permissions and written consent of the patients were obtained for the&#xD;
        implementation of the study. Number, percentage, mean, standard deviation, minimum and&#xD;
        maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests,&#xD;
        the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and&#xD;
        Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 6, 2019</start_date>
    <completion_date type="Actual">July 8, 2023</completion_date>
    <primary_completion_date type="Actual">March 21, 2020</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>State Anxiety Scale (SAS)</measure>
      <time_frame>Change in anxiety score during Nature Sounds and Music, an average of 10 minutes</time_frame>
      <description>State Anxiety Scale (SAS) is used to determine how an individual feels at a certain moment and under certain conditions. According to the degree of severity of the emotions, thoughts or behaviors expressed by the items, &quot;not at all&quot; (1), &quot;a little&quot; (2), &quot;a lot&quot; (3), &quot;completely&quot; (4) in the scale. Some of the items in the scale are direct statements and some of them are reversed statements.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Trait Anxiety Scale (TAS)</measure>
      <time_frame>Change in anxiety score during Nature Sounds and Music, an average of 10 minutes</time_frame>
      <description>The Trait Anxiety Scale (TAS) is used to determine how the individual usually perceives themselves. The items are scored as &quot;almost never&quot; (1), &quot;sometimes&quot; (2), &quot;very often&quot; (3) and &quot;almost always&quot; (4) according to the frequency of the feelings, thoughts or behaviors expressed by the items. The items in the scale are in the form of direct and inverted statements.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Hemodialysis Complication</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Assigned Interventions</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>It was explained to the patients in the nature sounds group that nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over. The patients listened to nature sounds for 30 minutes in three HD sessions for one week under the supervision of the researcher.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in the control group were not intervened by the researcher during the HD sessions. Before the first HD session started, the &quot;Descriptive Characteristics Form&quot; and &quot;Trait Anxiety Scale&quot; were performed by the researcher while the patients were in the waiting room. Then, in every three HD sessions for one week, when the patients went to their beds, their vital signs were measured and recorded on the &quot;Vital Signs Monitoring Form&quot; and the &quot;State Anxiety Scale&quot; was administered just before the HD treatment session was started. Then, the vital signs of the patients were measured and recorded on the &quot;Vital Signs Monitoring Form&quot; at the 30th minute, 1st, 2nd, 3rd hour of the HD session and immediately after the end of the HD session. At the same time, the &quot;State Anxiety Scale&quot; was performed again immediately after the end of the HD session. The patient was then transferred out of the unit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Nature sounds</intervention_name>
      <description>Nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over.</description>
      <arm_group_label>Assigned Interventions</arm_group_label>
      <other_name>music</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
            -  Age range between 18 and 79,&#xD;
  &#xD;
            -  Receiving HD treatment for at least six months,&#xD;
  &#xD;
            -  Receiving three sessions of HD treatment per week on a regular outpatient basis at the&#xD;
               same institution.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any problem that prevents cognitive, affective and verbal communication,&#xD;
  &#xD;
            -  Having any psychiatric condition,&#xD;
  &#xD;
            -  Use of anxiolytic medication,&#xD;
  &#xD;
            -  Out of the criteria for inclusion in the study,&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Burdur Mehmet Akif Ersoy University</name>
        <address>
          <city>Burdur</city>
          <zip>15000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Hagemann PMS, Martin LC, Neme CMB. The effect of music therapy on hemodialysis patients' quality of life and depression symptoms. J Bras Nefrol. 2019 Jan-Mar;41(1):74-82. doi: 10.1590/2175-8239-jbn-2018-0023. Epub 2018 Sep 13.</citation>
      <PMID>30222176</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim Y, Evangelista LS, Park YG. Anxiolytic Effects of Music Interventions in Patients Receiving Incenter Hemodialysis: A Systematic Review and Meta-Analysis. Nephrol Nurs J. 2015 Jul-Aug;42(4):339-47; quiz 348.</citation>
      <PMID>26462307</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 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>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mehmet Akif Ersoy University</investigator_affiliation>
      <investigator_full_name>IMarasli</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All authors contributed to the interpretation, writing, and approval of the final manuscript.</ipd_description>
    </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/NCT05980845
  org study id: 12.09.2018-4
  nct id: NCT05980845
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study was conducted as a randomized controlled experimental research to examine the
        effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients.
  
        The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who
        received treatment in the hemodialysis units of three hospitals, one university, one
        education research and one state hospital in Antalya province, met the inclusion criteria and
        consented to participate in the study. Patients were homogenously divided into intervention
        (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age,
        gender and hemodialysis duration. Patients in the intervention group were subjected to nature
        sounds/music during the hemodialysis procedure, while patients in the control group were not
        subjected to any intervention during the procedure. The data were collected by face-to-face
        interview technique using the "Descriptive Characteristics Form", "Vital Signs Monitoring
        Form", "State Anxiety Inventory" and "Trait Anxiety Inventory". Ethics committee approval,
        institutional permissions and written consent of the patients were obtained for the
        implementation of the study. Number, percentage, mean, standard deviation, minimum and
        maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests,
        the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and
        Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: State Anxiety Scale (SAS)
  time frame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
  description: State Anxiety Scale (SAS) is used to determine how an individual feels at a certain moment and under certain conditions. According to the degree of severity of the emotions, thoughts or behaviors expressed by the items, "not at all" (1), "a little" (2), "a lot" (3), "completely" (4) in the scale. Some of the items in the scale are direct statements and some of them are reversed statements.
  measure: The Trait Anxiety Scale (TAS)
  time frame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
  description: The Trait Anxiety Scale (TAS) is used to determine how the individual usually perceives themselves. The items are scored as "almost never" (1), "sometimes" (2), "very often" (3) and "almost always" (4) according to the frequency of the feelings, thoughts or behaviors expressed by the items. The items in the scale are in the form of direct and inverted statements.
  arm group label: Assigned Interventions
  arm group type: Active Comparator
  description: It was explained to the patients in the nature sounds group that nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over. The patients listened to nature sounds for 30 minutes in three HD sessions for one week under the supervision of the researcher.
  arm group label: Control Group
  arm group type: No Intervention
  description: Patients in the control group were not intervened by the researcher during the HD sessions. Before the first HD session started, the "Descriptive Characteristics Form" and "Trait Anxiety Scale" were performed by the researcher while the patients were in the waiting room. Then, in every three HD sessions for one week, when the patients went to their beds, their vital signs were measured and recorded on the "Vital Signs Monitoring Form" and the "State Anxiety Scale" was administered just before the HD treatment session was started. Then, the vital signs of the patients were measured and recorded on the "Vital Signs Monitoring Form" at the 30th minute, 1st, 2nd, 3rd hour of the HD session and immediately after the end of the HD session. At the same time, the "State Anxiety Scale" was performed again immediately after the end of the HD session. The patient was then transferred out of the unit.
  intervention type: Behavioral
  intervention name: Nature sounds
  description: Nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over.
  arm group label: Assigned Interventions
  other name: music
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 79 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  citation: Hagemann PMS, Martin LC, Neme CMB. The effect of music therapy on hemodialysis patients' quality of life and depression symptoms. J Bras Nefrol. 2019 Jan-Mar;41(1):74-82. doi: 10.1590/2175-8239-jbn-2018-0023. Epub 2018 Sep 13.
  PMID: 30222176
  citation: Kim Y, Evangelista LS, Park YG. Anxiolytic Effects of Music Interventions in Patients Receiving Incenter Hemodialysis: A Systematic Review and Meta-Analysis. Nephrol Nurs J. 2015 Jul-Aug;42(4):339-47; quiz 348.
  PMID: 26462307
  responsible party type: Principal Investigator
  investigator affiliation: Mehmet Akif Ersoy University
  investigator full name: IMarasli
  investigator title: Principal Investigator
  mesh term: Anxiety Disorders
  sharing ipd: No
  ipd description: All authors contributed to the interpretation, writing, and approval of the final manuscript.