<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/NCT04500054</url>
  </required_header>
  <id_info>
    <org_study_id>(2019/165</org_study_id>
    <nct_id>NCT04500054</nct_id>
  </id_info>
  <brief_title>The Effects Of Music In Retrograde Intrarenal Surgery</brief_title>
  <official_title>The Effects Of Music Listening In Patients Undergoing Retrograde Intrarenal Surgery On Basic Life Findings, Anxiety, Pain, And The Amount Of Analgesic Used.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Afyonkarahisar Health Sciences University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Afyonkarahisar Health Sciences 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 aimed to investigate the effect of music listening during the preoperative and&#xD;
      postoperative stages in patients undergoing retrograde intrarenal surgery(RIRS) on basic life&#xD;
      findings, anxiety, pain, and the amount of analgesic used. This is a randomized controlled&#xD;
      experimental study.&#xD;
&#xD;
      The study was conducted with two groups: the intervention group (n=30) and control group&#xD;
      (n=30). The control group received standard care. In contrast, the intervention group, in&#xD;
      addition to standard care, was listened to the music by the researchers for 15 minutes one&#xD;
      hour before their surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale for Anxiety (VAS-A)</measure>
    <time_frame>2 days</time_frame>
    <description>VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing &quot;no anxiety&quot; and 10 points showing &quot;I feel a lot of anxiety&quot; .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale for Pain (VAS)</measure>
    <time_frame>1 day</time_frame>
    <description>VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as &quot;no pain&quot; with 0 points, and &quot;the most severe pain imaginable&quot; with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Retrograde Intrarenal Surgery</condition>
  <arm_group>
    <arm_group_label>Music Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The music intervention group listened to the music by the researchers for the duration of 15 minutes one hour before the surgery as well as the standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group patients received standard care only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Listening</intervention_name>
    <description>The music type was chosen by the patients and researchers did not have any influence on their choices.</description>
    <arm_group_label>Music Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or above,&#xD;
&#xD;
          -  had elective RIRS,&#xD;
&#xD;
          -  without hearing/speech impairment,&#xD;
&#xD;
          -  without mental problems,&#xD;
&#xD;
          -  without a diagnosis of psychiatric disorders,&#xD;
&#xD;
          -  without a diagnosis of depression,&#xD;
&#xD;
          -  had the surgery under general anesthesia,&#xD;
&#xD;
          -  and volunteered to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age,&#xD;
&#xD;
          -  with hearing/speech impairment,&#xD;
&#xD;
          -  with mental problems,&#xD;
&#xD;
          -  with a diagnosis of psychiatric disorders,&#xD;
&#xD;
          -  with a diagnosis of depression,&#xD;
&#xD;
          -  undergoing the surgery through spinal anesthesia,&#xD;
&#xD;
          -  not willing to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Afyonkarahisar Health Science University</name>
      <address>
        <city>Afyonkarahisar</city>
        <state>Centre</state>
        <zip>03200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Afyonkarahisar Health Sciences University</investigator_affiliation>
    <investigator_full_name>Yeliz Ciğerci</investigator_full_name>
    <investigator_title>Assistant Proffesor PhD</investigator_title>
  </responsible_party>
  <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/NCT04500054
org study id: (2019/165
nct id: NCT04500054
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to investigate the effect of music listening during the preoperative and
      postoperative stages in patients undergoing retrograde intrarenal surgery(RIRS) on basic life
      findings, anxiety, pain, and the amount of analgesic used. This is a randomized controlled
      experimental study.

      The study was conducted with two groups: the intervention group (n=30) and control group
      (n=30). The control group received standard care. In contrast, the intervention group, in
      addition to standard care, was listened to the music by the researchers for 15 minutes one
      hour before their surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Visual Analog Scale for Anxiety (VAS-A)
time frame: 2 days
description: VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety" .
measure: Visual Analog Scale for Pain (VAS)
time frame: 1 day
description: VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.
arm group label: Music Intervention Group
arm group type: Experimental
description: The music intervention group listened to the music by the researchers for the duration of 15 minutes one hour before the surgery as well as the standard care.
arm group label: No Intervention Group
arm group type: No Intervention
description: The control group patients received standard care only.
intervention type: Other
intervention name: Music Listening
description: The music type was chosen by the patients and researchers did not have any influence on their choices.
arm group label: Music Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Afyonkarahisar Health Sciences University
investigator full name: Yeliz Ciğerci
investigator title: Assistant Proffesor PhD
sharing ipd: No