<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/NCT03816501</url>
  </required_header>
  <id_info>
    <org_study_id>Anxiety</org_study_id>
    <nct_id>NCT03816501</nct_id>
  </id_info>
  <brief_title>Effect of Preoperative Music on Anxiety</brief_title>
  <official_title>The Effect of Favorite Music on Postoperative Anxiety and Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Diskapi Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Diskapi Training and Research 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>
      In this study, we are planning to evaluate whether listening to the music of the patient's&#xD;
      choice preoperatively contributes to postoperative anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative anxiety can be detected via structured and standardised screening by the State -&#xD;
      Trait Anxiety Inventory (STAI) I and II.&#xD;
&#xD;
      117 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70&#xD;
      will be included in our study. preoperative STAI I and II score (anxiety questionnaire) will&#xD;
      be applied to each patient. The patients will be divided into two groups as preoperative&#xD;
      music played and not played. The list of patients listening to the music will be played&#xD;
      through the headphones which are the preference of the patients. The postoperative STAI&#xD;
      questionnaire will be applied again. results will be evaluated statistically&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>STAI score</measure>
    <time_frame>24 hours</time_frame>
    <description>preoperative and postoperative STAI I and II score questions will be asked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>11-point numerical rating scale (NRS)</measure>
    <time_frame>24 hours</time_frame>
    <description>11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Music on Postoperative Anxiety</condition>
  <arm_group>
    <arm_group_label>music</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The preference of the patients will be listened to preoperatively through the headphones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no music</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>preoperative music will not be listened</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>music</intervention_name>
    <description>The preference of the patients will be listened to preoperatively through the headphones</description>
    <arm_group_label>music</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no music</intervention_name>
    <description>the patients will not be listened</description>
    <arm_group_label>no music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inguinal hernia surgery&#xD;
&#xD;
          -  speak Turkish language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with dementia and psychiatric disorders&#xD;
&#xD;
          -  anxiolytic and psychiatric drug users&#xD;
&#xD;
          -  patients without written consent&#xD;
&#xD;
          -  poor vision,&#xD;
&#xD;
          -  significant hearing loss,&#xD;
&#xD;
          -  active opioid use,&#xD;
&#xD;
          -  unwillingness to participate in the study&#xD;
&#xD;
          -  unwillingness to listening to music&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Diskapi Teaching and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <state>Altindag</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Diskapi Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Fatma Kavak Akelma</investigator_full_name>
    <investigator_title>anesthesiology and reanimation specialist doctor</investigator_title>
  </responsible_party>
  <keyword>postoperative anxiety</keyword>
  <keyword>State - Trait Anxiety Inventory</keyword>
  <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>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03816501
org study id: Anxiety
nct id: NCT03816501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, we are planning to evaluate whether listening to the music of the patient's
      choice preoperatively contributes to postoperative anxiety.
Preoperative anxiety can be detected via structured and standardised screening by the State -
      Trait Anxiety Inventory (STAI) I and II.

      117 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70
      will be included in our study. preoperative STAI I and II score (anxiety questionnaire) will
      be applied to each patient. The patients will be divided into two groups as preoperative
      music played and not played. The list of patients listening to the music will be played
      through the headphones which are the preference of the patients. The postoperative STAI
      questionnaire will be applied again. results will be evaluated statistically
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: STAI score
time frame: 24 hours
description: preoperative and postoperative STAI I and II score questions will be asked.
measure: 11-point numerical rating scale (NRS)
time frame: 24 hours
description: 11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
arm group label: music
arm group type: Other
description: The preference of the patients will be listened to preoperatively through the headphones.
arm group label: no music
arm group type: Other
description: preoperative music will not be listened
intervention type: Other
intervention name: music
description: The preference of the patients will be listened to preoperatively through the headphones
arm group label: music
intervention type: Other
intervention name: no music
description: the patients will not be listened
arm group label: no music
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara Diskapi Training and Research Hospital
investigator full name: Fatma Kavak Akelma
investigator title: anesthesiology and reanimation specialist doctor
mesh term: Anxiety Disorders
sharing ipd: No