<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/NCT04466202</url>
  </required_header>
  <id_info>
    <org_study_id>2020.02.13-07</org_study_id>
    <nct_id>NCT04466202</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy</brief_title>
  <official_title>The Effect of Music With Structured Verbal Training on Pain, Anxiety and Satisfaction During Prostate Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi</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>
      Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in&#xD;
      the diagnosis of prostate cancer. This procedure can be very painful and anxious for men.&#xD;
      Various pharmacological methods can be used to relieve patients' pain and discomfort during&#xD;
      TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions&#xD;
      for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological&#xD;
      method, is effective in this regard. The aim of this study is to evaluate the effect of music&#xD;
      with structured verbal training on patients' pain, anxiety and satisfaction levels during&#xD;
      transrectal ultrasound-guided prostate biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although there have been several studies examining the effect of music on pain and / or&#xD;
      anxiety during TRUS prostate biopsy, only one study has been found examining the effect of&#xD;
      stress management (music and one-to-one simulation training) on patients' pain and anxiety&#xD;
      levels. In addition, there is only one study on the effectiveness of the training method&#xD;
      (written and video-based training) on anxiety levels of patients related to prostate biopsy.&#xD;
      For this reason, it is thought that music will be more effective on pain and anxiety levels&#xD;
      along with structured verbal training to alleviate the discomfort associated with patients'&#xD;
      biopsy procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change on pain intensity as measured by Visual Analog Scale</measure>
    <time_frame>&quot;just before procedure&quot;, &quot;during procedure&quot; and &quot;5 minutes after procedure&quot;</time_frame>
    <description>The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>score change on anxiety level as measured by State-Trait Anxiety Inventory</measure>
    <time_frame>&quot;just before procedure&quot; and &quot;5 minutes after procedure&quot;</time_frame>
    <description>The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain</condition>
  <condition>Anxiety</condition>
  <condition>Satisfaction</condition>
  <condition>Urological Nursing</condition>
  <arm_group>
    <arm_group_label>Music Group with Structured Verbal Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music with structured verbal training was applied during transrectal ultrasound guided prostate biopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group did not listen to music during the procedure, and they received routine training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music with Structured Verbal Training</intervention_name>
    <description>Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.</description>
    <arm_group_label>Music Group with Structured Verbal Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being over the age of 40&#xD;
&#xD;
          -  male gender&#xD;
&#xD;
          -  transrectal ultrasound guided prostate biopsy for the first time&#xD;
&#xD;
          -  agreeing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of any contraindication for prostate biopsy&#xD;
&#xD;
          -  any analgesic used 24 hours before prostate biopsy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elif Gezginci, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saglik Bilimleri Universitesi</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.</citation>
    <PMID>11733293</PMID>
  </reference>
  <reference>
    <citation>Chang YH, Oh TH, Lee JW, Park SC, Seo IY, Jeong HJ, Kwon WA. Listening to music during transrectal ultrasound-guided prostate biopsy decreases anxiety, pain and dissatisfaction in patients: a pilot randomized controlled trial. Urol Int. 2015;94(3):337-41. doi: 10.1159/000368420. Epub 2014 Dec 18.</citation>
    <PMID>25531837</PMID>
  </reference>
  <reference>
    <citation>Chiu LP, Tung HH, Lin KC, Lai YW, Chiu YC, Chen SS, Chiu AW. Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Patient Prefer Adherence. 2016 Feb 11;10:147-52. doi: 10.2147/PPA.S96991. eCollection 2016.</citation>
    <PMID>26929606</PMID>
  </reference>
  <reference>
    <citation>Cho SW, Choi HJ. Effect of Music on Reducing Anxiety for Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies: Randomized Prospective Trial. Urol J. 2016 Apr 16;13(2):2612-4.</citation>
    <PMID>27085561</PMID>
  </reference>
  <reference>
    <citation>Chopra S, Rowe EW, Laniado M, Patel A. A prospective study analysing the effect of pain on probe insertion, and the biopsy strategy, on the patients' perception of pain during TRUS-guided biopsy of the prostate. N Z Med J. 2008 Dec 12;121(1287):39-43.</citation>
    <PMID>19098966</PMID>
  </reference>
  <reference>
    <citation>Packiam VT, Nottingham CU, Cohen AJ, Eggener SE, Gerber GS. No Effect of Music on Anxiety and Pain During Transrectal Prostate Biopsies: A Randomized Trial. Urology. 2018 Jul;117:31-35. doi: 10.1016/j.urology.2018.04.014. Epub 2018 Apr 27.</citation>
    <PMID>29709434</PMID>
  </reference>
  <reference>
    <citation>Tsivian M, Qi P, Kimura M, Chen VH, Chen SH, Gan TJ, Polascik TJ. The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology. 2012 Jan;79(1):32-6. doi: 10.1016/j.urology.2011.09.037.</citation>
    <PMID>22202544</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
    <investigator_full_name>Elif Gezginci</investigator_full_name>
    <investigator_title>RN, PhD, Asst Prof</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Nursing</keyword>
  <keyword>Pain</keyword>
  <keyword>Satisfaction</keyword>
  <keyword>Prostate biopsy</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/NCT04466202
org study id: 2020.02.13-07
nct id: NCT04466202
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in
      the diagnosis of prostate cancer. This procedure can be very painful and anxious for men.
      Various pharmacological methods can be used to relieve patients' pain and discomfort during
      TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions
      for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological
      method, is effective in this regard. The aim of this study is to evaluate the effect of music
      with structured verbal training on patients' pain, anxiety and satisfaction levels during
      transrectal ultrasound-guided prostate biopsy.
Although there have been several studies examining the effect of music on pain and / or
      anxiety during TRUS prostate biopsy, only one study has been found examining the effect of
      stress management (music and one-to-one simulation training) on patients' pain and anxiety
      levels. In addition, there is only one study on the effectiveness of the training method
      (written and video-based training) on anxiety levels of patients related to prostate biopsy.
      For this reason, it is thought that music will be more effective on pain and anxiety levels
      along with structured verbal training to alleviate the discomfort associated with patients'
      biopsy procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: change on pain intensity as measured by Visual Analog Scale
time frame: "just before procedure", "during procedure" and "5 minutes after procedure"
description: The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.
measure: score change on anxiety level as measured by State-Trait Anxiety Inventory
time frame: "just before procedure" and "5 minutes after procedure"
description: The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.
arm group label: Music Group with Structured Verbal Training
arm group type: Experimental
description: Music with structured verbal training was applied during transrectal ultrasound guided prostate biopsy.
arm group label: Control Group
arm group type: No Intervention
description: The control group did not listen to music during the procedure, and they received routine training.
intervention type: Other
intervention name: Music with Structured Verbal Training
description: Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.
arm group label: Music Group with Structured Verbal Training
criteria: 
gender: Male
gender based: Yes
minimum age: 40 Years
maximum age: 86 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elif Gezginci, PhD
role: Principal Investigator
affiliation: Saglik Bilimleri Universitesi
facility: 
country: Turkey
citation: Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PMID: 11733293
citation: Chang YH, Oh TH, Lee JW, Park SC, Seo IY, Jeong HJ, Kwon WA. Listening to music during transrectal ultrasound-guided prostate biopsy decreases anxiety, pain and dissatisfaction in patients: a pilot randomized controlled trial. Urol Int. 2015;94(3):337-41. doi: 10.1159/000368420. Epub 2014 Dec 18.
PMID: 25531837
citation: Chiu LP, Tung HH, Lin KC, Lai YW, Chiu YC, Chen SS, Chiu AW. Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Patient Prefer Adherence. 2016 Feb 11;10:147-52. doi: 10.2147/PPA.S96991. eCollection 2016.
PMID: 26929606
citation: Cho SW, Choi HJ. Effect of Music on Reducing Anxiety for Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies: Randomized Prospective Trial. Urol J. 2016 Apr 16;13(2):2612-4.
PMID: 27085561
citation: Chopra S, Rowe EW, Laniado M, Patel A. A prospective study analysing the effect of pain on probe insertion, and the biopsy strategy, on the patients' perception of pain during TRUS-guided biopsy of the prostate. N Z Med J. 2008 Dec 12;121(1287):39-43.
PMID: 19098966
citation: Packiam VT, Nottingham CU, Cohen AJ, Eggener SE, Gerber GS. No Effect of Music on Anxiety and Pain During Transrectal Prostate Biopsies: A Randomized Trial. Urology. 2018 Jul;117:31-35. doi: 10.1016/j.urology.2018.04.014. Epub 2018 Apr 27.
PMID: 29709434
citation: Tsivian M, Qi P, Kimura M, Chen VH, Chen SH, Gan TJ, Polascik TJ. The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology. 2012 Jan;79(1):32-6. doi: 10.1016/j.urology.2011.09.037.
PMID: 22202544
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi
investigator full name: Elif Gezginci
investigator title: RN, PhD, Asst Prof
mesh term: Anxiety Disorders
sharing ipd: No