<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/NCT02255916</url>
  </required_header>
  <id_info>
    <org_study_id>MTO_03</org_study_id>
    <nct_id>NCT02255916</nct_id>
  </id_info>
  <brief_title>Short-term Effects of Sound-bed Music Therapy in Healthy Caregivers of a Hospital Oncology Ward (MTO_03)</brief_title>
  <acronym>MTO_03</acronym>
  <official_title>Short-term Effects of Live Sound-bed Music on Physiological and Psychological Parameters in Healthy Oncology Staff - A Randomized Controlled Trial With Crossover Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ARCIM Institute Academic Research in Complementary and Integrative Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ARCIM Institute Academic Research in Complementary and Integrative Medicine</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of live sound-bed music on&#xD;
      physiological and psychological parameters in staff of a hospital oncology ward.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Basler Mood Questionnaire (BBS)</measure>
    <time_frame>30 minutes</time_frame>
    <description>filled in by the participants four times (before and after the music intervention respectively no intervention)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>additional questions addressing body warmth, subjective painlessness and general mental state</measure>
    <time_frame>30 minutes</time_frame>
    <description>filled in by the participants four times (before and after the music intervention respectively no intervention)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate variability -Parameter (HRV)</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>Standard Deviation of Normal to Normal (heart rate) (SDNN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRV-Parameter</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>Root Mean Square of the Successive Differences (RMSSD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRV-Parameter</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>pNN50 (the proportion of NN50 divided by total number of NNs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRV-Parameter</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>ratio low frequency to high frequency (LF/HF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRV-Parameter</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>very low frequency (VLF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRV-Parameter</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>NN50 (the number of pairs of successive NNs that differ by more than 50 ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Anxiety and Depression Scale</measure>
    <time_frame>filled in by the participants as baseline measurement at the beginning</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sense of Coherence (SOC-13)</measure>
    <time_frame>filled in by the participants as baseline measurement at the beginning</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 Health Survey</measure>
    <time_frame>filled in by the participants as baseline measurement at the beginning</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electromyography (EMG)</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>Electromyography of the shoulder muscles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin temperature</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin conductance</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours.</time_frame>
    <description>skin conductance measured at the fingertip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>20 minutes</time_frame>
    <description>via the saliva of the participants before and after the music intervention respectively no intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse-Transit-Time (PTT)</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours</time_frame>
    <description>Pulse-Transit-Time (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perfusion-Index (PI)</measure>
    <time_frame>Physiological parameters are measured twice over a period of 2 hours</time_frame>
    <description>Perfusion-Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Healthy Adults (Hospital Oncology Ward)</condition>
  <condition>Physiological Phenomena (e.g.HRV Parameters)</condition>
  <condition>Morphology</condition>
  <arm_group>
    <arm_group_label>Controll</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No sound-bed intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>live sound-bed music intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music</intervention_name>
    <description>live sound-bed music intervention</description>
    <arm_group_label>Music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed informed consent of the participant&#xD;
&#xD;
          -  affiliation to the staff of the hospital oncology ward&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insufficient knowledge of the German language&#xD;
&#xD;
          -  alcohol, caffeine or nicotine less than 3 hours before the beginning&#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>
  <overall_official>
    <last_name>Jan Vagedes, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>ARCIM-Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Filderklinik</name>
      <address>
        <city>Filderstadt</city>
        <state>Baden-Württemberg</state>
        <zip>70794</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>January 12, 2015</last_update_submitted>
  <last_update_submitted_qc>January 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oncology</keyword>
  <keyword>psychology</keyword>
  <keyword>cancer</keyword>
  <keyword>music</keyword>
  <keyword>sound-bed</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02255916
org study id: MTO_03
nct id: NCT02255916
lead sponsor: 
The purpose of this study is to determine the effects of live sound-bed music on
      physiological and psychological parameters in staff of a hospital oncology ward.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Basler Mood Questionnaire (BBS)
time frame: 30 minutes
description: filled in by the participants four times (before and after the music intervention respectively no intervention)
measure: additional questions addressing body warmth, subjective painlessness and general mental state
time frame: 30 minutes
description: filled in by the participants four times (before and after the music intervention respectively no intervention)
measure: heart rate variability -Parameter (HRV)
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: Standard Deviation of Normal to Normal (heart rate) (SDNN)
measure: HRV-Parameter
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: Root Mean Square of the Successive Differences (RMSSD)
measure: HRV-Parameter
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: pNN50 (the proportion of NN50 divided by total number of NNs)
measure: HRV-Parameter
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: ratio low frequency to high frequency (LF/HF)
measure: HRV-Parameter
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: very low frequency (VLF)
measure: HRV-Parameter
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: NN50 (the number of pairs of successive NNs that differ by more than 50 ms)
measure: Hamilton Anxiety and Depression Scale
time frame: filled in by the participants as baseline measurement at the beginning
measure: Sense of Coherence (SOC-13)
time frame: filled in by the participants as baseline measurement at the beginning
description: questionnaire
measure: SF-12 Health Survey
time frame: filled in by the participants as baseline measurement at the beginning
measure: Electromyography (EMG)
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: Electromyography of the shoulder muscles
measure: Skin temperature
time frame: Physiological parameters are measured twice over a period of 2 hours.
measure: skin conductance
time frame: Physiological parameters are measured twice over a period of 2 hours.
description: skin conductance measured at the fingertip
measure: Cortisol
time frame: 20 minutes
description: via the saliva of the participants before and after the music intervention respectively no intervention
measure: Pulse-Transit-Time (PTT)
time frame: Physiological parameters are measured twice over a period of 2 hours
description: Pulse-Transit-Time (ms)
measure: Perfusion-Index (PI)
time frame: Physiological parameters are measured twice over a period of 2 hours
description: Perfusion-Index
arm group label: Controll
arm group type: No Intervention
description: No sound-bed intervention
arm group label: Music
arm group type: Experimental
description: live sound-bed music intervention
intervention type: Other
intervention name: Music
description: live sound-bed music intervention
arm group label: Music
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Vagedes, Dr.
role: Principal Investigator
affiliation: ARCIM-Institute
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Neoplasms