<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/NCT04446143</url>
  </required_header>
  <id_info>
    <org_study_id>5200230</org_study_id>
    <nct_id>NCT04446143</nct_id>
  </id_info>
  <brief_title>Effects on Mindfulness Meditation on Patient's Satisfaction During Urodynamic Study</brief_title>
  <official_title>Effects of Mindfulness Meditation on Patients' Satisfaction During Urodynamic Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</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>
      The purpose of this investigator-initiated study is to evaluate if mindfulness-based stress&#xD;
      reduction (MBSR) will improve satisfaction and reduce anxiety during a urodynamic study&#xD;
      (UDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urodynamic studies (UDS) are used to measure the functionality of the bladder and urethra to&#xD;
      be able to evaluate lower urinary tract symptoms (LUTS). UDS consists of catheterization,&#xD;
      uroflow and cystometrogram. Intravesical, vaginal or rectal transducer placements, and&#xD;
      placement of perineal electrodes are part of the study protocol. During the study the bladder&#xD;
      will be filled slowly with sterile fluid and the patient will be asked about sensation of&#xD;
      filling. At the end of the study the patient will be asked to void.&#xD;
&#xD;
      Although beneficial for diagnosis of underlying LUTS, UDS maybe associated with heightened&#xD;
      patient anxiety and feeling of discomfort. In a recently published pilot study, it was shown&#xD;
      that a mindfulness-based stress reduction (MBSR) protocol may help improve a patient's&#xD;
      emotional health and perception of UDS. To validate the findings from this previous study,&#xD;
      the current study aims to implement a MBSR protocol in a randomized prospective study.&#xD;
      Patients scheduled for UDS will be randomized into two groups. One group will listen to&#xD;
      mindfulness meditation prior to the UDS and the other group won't.&#xD;
&#xD;
      All patients will complete validated questionnaires to assess their satisfaction, anxiety and&#xD;
      pain level as well as lower urinary tract symptoms before and after intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Actual">July 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 15, 2021</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>
    <intervention_model_description>Subject randomization will use permutated blocks and assignments in concealed consecutively numbered envelops. Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete, where as the control group will be seated in a quiet empty room where they wait for 10 min.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction during the urodynamic study testing</measure>
    <time_frame>1 year</time_frame>
    <description>Likert scale will measure satisfaction with urodynamics in both groups. The scale ranges are: very dissatisfied=0, dissatisfied=1, somehow satisfied=2, satisfied=3, very satisfied=4), with 0 as the worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self evaluation of anxiety and comfort level</measure>
    <time_frame>1 year</time_frame>
    <description>The State-Trait Anxiety Inventory (STAI 6) score will be obtained before and after the study. It measures stress and anxiety. It ranges from: not al all=1, somewhat=2, moderately so=3, very much so=4), with 4 as the worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level</measure>
    <time_frame>1 year</time_frame>
    <description>The visualised analog pain score (VAS) will be obtained before and after the study. It measure the degree of pain and a range between 0-10 (0=no pain et all and 10=worst pain ever), with 10 as the worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Personal Satisfaction</condition>
  <arm_group>
    <arm_group_label>Application of mindfulness meditation prior to UDS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No meditation prior to UDS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will be seated in a quiet empty room where they wait for 10 min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness meditation</intervention_name>
    <description>Mindfulness meditation</description>
    <arm_group_label>Application of mindfulness meditation prior to UDS</arm_group_label>
    <arm_group_label>No meditation prior to UDS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and male patients between ages 18 and 99 with clinical indication for UDS&#xD;
             ordered by treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None English speakers will be recruited for this study.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prioners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All genders and gender-identities (phenotype, genotype) are eligible for this study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Staack</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda Univ Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Faculty Medical Offices</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Uberoi P, Smitherman A, Aden J, Park G, Jellison F. Incorporation of Mindfulness Exercises to Reduce Anxiety During Urodynamic Testing: A Randomized Single-Blind Controlled Pilot Trial. J Altern Complement Med. 2020 Jan;26(1):74-75. doi: 10.1089/acm.2018.0447. Epub 2019 Sep 25. No abstract available.</citation>
    <PMID>31553223</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meditation, urodynamics, satisfaction, pain, anxiety</keyword>
  <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/NCT04446143
org study id: 5200230
nct id: NCT04446143
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this investigator-initiated study is to evaluate if mindfulness-based stress
      reduction (MBSR) will improve satisfaction and reduce anxiety during a urodynamic study
      (UDS).
Urodynamic studies (UDS) are used to measure the functionality of the bladder and urethra to
      be able to evaluate lower urinary tract symptoms (LUTS). UDS consists of catheterization,
      uroflow and cystometrogram. Intravesical, vaginal or rectal transducer placements, and
      placement of perineal electrodes are part of the study protocol. During the study the bladder
      will be filled slowly with sterile fluid and the patient will be asked about sensation of
      filling. At the end of the study the patient will be asked to void.

      Although beneficial for diagnosis of underlying LUTS, UDS maybe associated with heightened
      patient anxiety and feeling of discomfort. In a recently published pilot study, it was shown
      that a mindfulness-based stress reduction (MBSR) protocol may help improve a patient's
      emotional health and perception of UDS. To validate the findings from this previous study,
      the current study aims to implement a MBSR protocol in a randomized prospective study.
      Patients scheduled for UDS will be randomized into two groups. One group will listen to
      mindfulness meditation prior to the UDS and the other group won't.

      All patients will complete validated questionnaires to assess their satisfaction, anxiety and
      pain level as well as lower urinary tract symptoms before and after intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subject randomization will use permutated blocks and assignments in concealed consecutively numbered envelops. Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete, where as the control group will be seated in a quiet empty room where they wait for 10 min.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Satisfaction during the urodynamic study testing
time frame: 1 year
description: Likert scale will measure satisfaction with urodynamics in both groups. The scale ranges are: very dissatisfied=0, dissatisfied=1, somehow satisfied=2, satisfied=3, very satisfied=4), with 0 as the worse outcome.
measure: Self evaluation of anxiety and comfort level
time frame: 1 year
description: The State-Trait Anxiety Inventory (STAI 6) score will be obtained before and after the study. It measures stress and anxiety. It ranges from: not al all=1, somewhat=2, moderately so=3, very much so=4), with 4 as the worse outcome.
measure: Pain level
time frame: 1 year
description: The visualised analog pain score (VAS) will be obtained before and after the study. It measure the degree of pain and a range between 0-10 (0=no pain et all and 10=worst pain ever), with 10 as the worse outcome.
arm group label: Application of mindfulness meditation prior to UDS
arm group type: Other
description: Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.
arm group label: No meditation prior to UDS
arm group type: Active Comparator
description: The control group will be seated in a quiet empty room where they wait for 10 min.
intervention type: Behavioral
intervention name: Mindfulness meditation
description: Mindfulness meditation
arm group label: Application of mindfulness meditation prior to UDS
arm group label: No meditation prior to UDS
criteria: 
gender: All
gender based: Yes
gender description: All genders and gender-identities (phenotype, genotype) are eligible for this study.
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Staack
role: Principal Investigator
affiliation: Loma Linda Univ Health
facility: 
country: United States
citation: Uberoi P, Smitherman A, Aden J, Park G, Jellison F. Incorporation of Mindfulness Exercises to Reduce Anxiety During Urodynamic Testing: A Randomized Single-Blind Controlled Pilot Trial. J Altern Complement Med. 2020 Jan;26(1):74-75. doi: 10.1089/acm.2018.0447. Epub 2019 Sep 25. No abstract available.
PMID: 31553223
responsible party type: Sponsor
sharing ipd: No