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/NCT05980468</url>
    </required_header>
    <id_info>
      <org_study_id>05/2023</org_study_id>
      <nct_id>NCT05980468</nct_id>
    </id_info>
    <brief_title>The Effect of Music Therapy on Nurses</brief_title>
    <official_title>The Effect of Music Therapy on Nurses' Comfort Levels</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>TC Erciyes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>TC Erciyes 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>
        This study was planned to examine the effect of music therapy on the comfort levels of&#xD;
        nurses. In the study, data will be collected by using Descriptive Characteristics Information&#xD;
        Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in&#xD;
        the intervention or control group will be determined by simple randomization. Music&#xD;
        intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20&#xD;
        minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the&#xD;
        participants again.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was planned to examine the effect of music therapy on the comfort levels of&#xD;
        nurses. This study will be conducted as a randomized controlled experimental study. In the&#xD;
        sample calculation, it was determined that for Power = 0.8 (beta = 0.2), alpha = 0.05 and&#xD;
        effect size = 0.7, the sample size should be 66, 33 for the intervention group and 33 for the&#xD;
        control group. In the study, data will be collected by using Descriptive Characteristics&#xD;
        Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria&#xD;
        will be in the intervention or control group will be determined by simple randomization.&#xD;
        Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week,&#xD;
        20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the&#xD;
        participants again. Research data will be analyzed in SPSS-25 package program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 8, 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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comfort</measure>
      <time_frame>5 weeks after first meeting</time_frame>
      <description>The scale consists of 39 items in total. Each statement in the scale has a Likert-type rating ranging from 1-4 from &quot;strongly disagree&quot; to &quot;strongly agree&quot;. 24 of the expressions are positive and 15 are negative, and negative items are reversed in scoring. Accordingly, a high score (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1) indicates high comfort in negative statements, and a high score (4) indicates low comfort. The Cronbach alpha coefficient was found to be 0.915.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Music Therapy</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. Forms will be applied at the first meeting and for five weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No application has been made. Forms will be applied at the first meeting and for five weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>music therapy</intervention_name>
      <description>Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have at least one year of working experience&#xD;
  &#xD;
            -  Have not participated in any music therapy session before&#xD;
  &#xD;
            -  No hearing problems&#xD;
  &#xD;
            -  Absence of neurological/psychiatric disorders&#xD;
  &#xD;
            -  Nurses who volunteered to participate in the study will be included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who use another relaxation methods,&#xD;
  &#xD;
            -  Nurses who do not agree to participate in the study will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sevda Korkut</last_name>
      <role>Principal Investigator</role>
      <affiliation>TC Erciyes University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ayşe Topuz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Karamanoğlu Mehmetbey University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sevda Korkut, PhD</last_name>
      <phone>+90 352 207 66 66</phone>
      <email>skorkut@erciyes.edu.tr</email>
    </overall_contact>
    <verification_date>September 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>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>TC Erciyes University</investigator_affiliation>
      <investigator_full_name>Sevda Korkut</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>nurse</keyword>
    <keyword>comfort</keyword>
    <keyword>music therapy</keyword>
    <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/NCT05980468
  org study id: 05/2023
  nct id: NCT05980468
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned to examine the effect of music therapy on the comfort levels of
        nurses. In the study, data will be collected by using Descriptive Characteristics Information
        Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in
        the intervention or control group will be determined by simple randomization. Music
        intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20
        minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the
        participants again.
  This study was planned to examine the effect of music therapy on the comfort levels of
        nurses. This study will be conducted as a randomized controlled experimental study. In the
        sample calculation, it was determined that for Power = 0.8 (beta = 0.2), alpha = 0.05 and
        effect size = 0.7, the sample size should be 66, 33 for the intervention group and 33 for the
        control group. In the study, data will be collected by using Descriptive Characteristics
        Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria
        will be in the intervention or control group will be determined by simple randomization.
        Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week,
        20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the
        participants again. Research data will be analyzed in SPSS-25 package program.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Comfort
  time frame: 5 weeks after first meeting
  description: The scale consists of 39 items in total. Each statement in the scale has a Likert-type rating ranging from 1-4 from "strongly disagree" to "strongly agree". 24 of the expressions are positive and 15 are negative, and negative items are reversed in scoring. Accordingly, a high score (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1) indicates high comfort in negative statements, and a high score (4) indicates low comfort. The Cronbach alpha coefficient was found to be 0.915.
  arm group label: Intervention group
  arm group type: Experimental
  description: Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. Forms will be applied at the first meeting and for five weeks.
  arm group label: Control group
  arm group type: No Intervention
  description: No application has been made. Forms will be applied at the first meeting and for five weeks.
  intervention type: Other
  intervention name: music therapy
  description: Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sevda Korkut
  role: Principal Investigator
  affiliation: TC Erciyes University
  last name: Ayşe Topuz
  role: Principal Investigator
  affiliation: Karamanoğlu Mehmetbey University
  last name: Sevda Korkut, PhD
  phone: +90 352 207 66 66
  email: skorkut@erciyes.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: TC Erciyes University
  investigator full name: Sevda Korkut
  investigator title: Assistant Professor
  sharing ipd: No