<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/NCT03791177</url>
  </required_header>
  <id_info>
    <org_study_id>AksarayUTRH2</org_study_id>
    <nct_id>NCT03791177</nct_id>
  </id_info>
  <brief_title>Urodynamics and Music</brief_title>
  <official_title>The Effects of Listening to Music on Anxiety, Pain and Satisfaction During Urodynamic Study : A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aksaray University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aksaray University Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Today music acts as an analgesic and anxiolytic in a safe, cheap and simple way. Several&#xD;
      trials have confirmed its potential administration and benefits in urology practice. We aimed&#xD;
      to assess the influence of music therapy on perceived anxiety and pain during outpatient&#xD;
      urodynamic study (UDS) using the Visual Analog Scale (VAS) and the State-Trait Anxiety&#xD;
      Inventory (STAI) in a prospective, randomized fashion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urodynamic study (UDS) is often used to help urologists to evaluate the functions of bladder&#xD;
      and urethra in outpatient clinic.1 Although a UDS is a reliable tool for accurate diagnosis,&#xD;
      the process itself can be accompanied by discomfort and pain as it includes the positioning&#xD;
      the catheters urethral and rectally, and the bladder filling. Reports of having such invasive&#xD;
      outpatient process whilst awake may demonstrate pain and disquiet that result in incomplete&#xD;
      examinations and patient noncompliance2,3.&#xD;
&#xD;
      Various pharmacologic options including lidocaine gel and catheter tip lubrication for&#xD;
      urethral catheterization were used to relieve pain and anxiety during UDS. Besides, there are&#xD;
      some non-pharmalogical methods such as patient education, heating pad, music, distraction and&#xD;
      relaxation4-6.&#xD;
&#xD;
      Music has been considered complementary treatment modality as cheap, safe and effective. In&#xD;
      various urological procedures including cystoscopy, transrectal prostate biopsy and&#xD;
      extracorporeal shock wave lithotripsy (ESWL) music has been proven helpful on pain and&#xD;
      anxiety levels 7-10. However, current literature presents limited and controversial data&#xD;
      evaluating the influence of music on pain and anxiety perspective of the patient during UDS.&#xD;
      We, therefore, aimed to assess the effect of music on patient satisfaction in a analgesic and&#xD;
      anxiolytic way during UDS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 29, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>The trial was blinded for data manager ( a nurse collecting the control and study group data) and statistician.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scale: VAS</measure>
    <time_frame>10 minutes after UDS</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Scale: STAI</measure>
    <time_frame>10 minutes after UDS</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Incontinence, Urinary</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 70 patients were included in the study. Using simple randomization method, the patients were acknowledged about the aim of the study and the cards with letters C (control) and S (study) were placed in closed envelopes and the patients were asked to draw a random envelope. After the draw, two groups were formed according to the letter as group I consisted of patients with C letter and group II consisted of patients with S letter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A total of 70 patients were included in the study. Using simple randomization method, the patients were acknowledged about the aim of the study and the cards with letters C (control) and S (study) were placed in closed envelopes and the patients were asked to draw a random envelope. After the draw, two groups were formed according to the letter as group I consisted of patients with C letter and group II consisted of patients with S letter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Therapy</intervention_name>
    <description>Patients in the study group were exposed to flute music therapy (Sufi musical recital - Huseyni mode) at low tempo (60-80 rhythm / min) with weak beats and calm rhythms during the UDS.&#xD;
This audition involves both vocal and instrumental music performed by a reed flute called 'Ney'. A competent lecturer who was specialized in music suggested all the musical compositions during the therapy</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria included paraplegia, hearing impairment, taking any analgesic or&#xD;
        anxiolytic drug to suppress the symptoms of anxiety until 24 hours prior to UDS, inability&#xD;
        to understand or fulfill commands during UDS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aksaray University Training and Research Hospital</name>
      <address>
        <city>Aksaray</city>
        <zip>68001</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aksaray University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Murat Gül</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Music</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</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/NCT03791177
org study id: AksarayUTRH2
nct id: NCT03791177
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Today music acts as an analgesic and anxiolytic in a safe, cheap and simple way. Several
      trials have confirmed its potential administration and benefits in urology practice. We aimed
      to assess the influence of music therapy on perceived anxiety and pain during outpatient
      urodynamic study (UDS) using the Visual Analog Scale (VAS) and the State-Trait Anxiety
      Inventory (STAI) in a prospective, randomized fashion
Urodynamic study (UDS) is often used to help urologists to evaluate the functions of bladder
      and urethra in outpatient clinic.1 Although a UDS is a reliable tool for accurate diagnosis,
      the process itself can be accompanied by discomfort and pain as it includes the positioning
      the catheters urethral and rectally, and the bladder filling. Reports of having such invasive
      outpatient process whilst awake may demonstrate pain and disquiet that result in incomplete
      examinations and patient noncompliance2,3.

      Various pharmacologic options including lidocaine gel and catheter tip lubrication for
      urethral catheterization were used to relieve pain and anxiety during UDS. Besides, there are
      some non-pharmalogical methods such as patient education, heating pad, music, distraction and
      relaxation4-6.

      Music has been considered complementary treatment modality as cheap, safe and effective. In
      various urological procedures including cystoscopy, transrectal prostate biopsy and
      extracorporeal shock wave lithotripsy (ESWL) music has been proven helpful on pain and
      anxiety levels 7-10. However, current literature presents limited and controversial data
      evaluating the influence of music on pain and anxiety perspective of the patient during UDS.
      We, therefore, aimed to assess the effect of music on patient satisfaction in a analgesic and
      anxiolytic way during UDS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
masking description: The trial was blinded for data manager ( a nurse collecting the control and study group data) and statistician.
measure: Pain Scale: VAS
time frame: 10 minutes after UDS
measure: Anxiety Scale: STAI
time frame: 10 minutes after UDS
arm group label: Study Group
arm group type: Experimental
description: A total of 70 patients were included in the study. Using simple randomization method, the patients were acknowledged about the aim of the study and the cards with letters C (control) and S (study) were placed in closed envelopes and the patients were asked to draw a random envelope. After the draw, two groups were formed according to the letter as group I consisted of patients with C letter and group II consisted of patients with S letter.
arm group label: Control Group
arm group type: Sham Comparator
description: A total of 70 patients were included in the study. Using simple randomization method, the patients were acknowledged about the aim of the study and the cards with letters C (control) and S (study) were placed in closed envelopes and the patients were asked to draw a random envelope. After the draw, two groups were formed according to the letter as group I consisted of patients with C letter and group II consisted of patients with S letter.
intervention type: Other
intervention name: Music Therapy
description: Patients in the study group were exposed to flute music therapy (Sufi musical recital - Huseyni mode) at low tempo (60-80 rhythm / min) with weak beats and calm rhythms during the UDS.
This audition involves both vocal and instrumental music performed by a reed flute called 'Ney'. A competent lecturer who was specialized in music suggested all the musical compositions during the therapy
arm group label: Control Group
arm group label: Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Aksaray University Training and Research Hospital
investigator full name: Murat Gül
investigator title: Assistant Professor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No