<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/NCT02991014</url>
  </required_header>
  <id_info>
    <org_study_id>MINTREP-UN</org_study_id>
    <nct_id>NCT02991014</nct_id>
  </id_info>
  <brief_title>Music-based Intervention for the Reduction of Pain</brief_title>
  <acronym>MINTREP</acronym>
  <official_title>Music-based Intervention for the Reduction of Pain and Stress in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the impact of listening to frequency-modulated music vs.&#xD;
      non-modulated music (both researcher-selected), and to test whether there are differential&#xD;
      effects on pain and stress perception. Further, these two conditions will be compared to a&#xD;
      third condition, in which participants will be exposed to self-selected non-modulated music.&#xD;
      It is hypothesized that both researcher-selected frequency-modulated music and self-selected&#xD;
      non-modulated music result in stronger decreases in stress and pain compared to&#xD;
      researcher-selected non-modulated music, while it is expected that there will be no&#xD;
      differences in researcher-selected frequency-modulated music and self-selected non-modulated&#xD;
      music. The intervention consists of ten sessions of music listening in the course of three&#xD;
      consecutive weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to compare the impact of three different music listening interventions on&#xD;
      stress and pain parameters. Participants will be assigned randomly to one of the conditions.&#xD;
      In order to avoid expectancy-related effects, participants in both the researcher- and&#xD;
      self-selected condition are told that they were allocated randomly to frequency-modulated or&#xD;
      non-modulated music. Therefore, subjects are fully blinded with regards to&#xD;
      frequency-modulation.&#xD;
&#xD;
      The study design is as follows:&#xD;
&#xD;
        -  Baseline measurement: assessment of resting state biological parameters and&#xD;
           questionnaires, CPT&#xD;
&#xD;
        -  Music listening sessions: ten sessions in three consecutive weeks including:&#xD;
&#xD;
             1. 60 minutes of music listening&#xD;
&#xD;
             2. CPT following music listening (sessions 1, 3, 6, 10 only)&#xD;
&#xD;
             3. Assessments: biological and subjective pain and stress parameters; music and mood&#xD;
                related parameters&#xD;
&#xD;
        -  Post measurement: assessment of resting state biological parameters and questionnaires,&#xD;
           CPT&#xD;
&#xD;
        -  Follow-up measurement: 4 weeks after intervention, assessment of resting state&#xD;
           biological parameters and questionnaires, CPT&#xD;
&#xD;
      Participants respond to health-related questions (chronic stress, stress reactivity, sleep&#xD;
      quality, fatigue, menstrual cycle phase) as well as mood and music-related questions at&#xD;
      baseline, post-intervention, and follow-up which are assessed as potential outcome,&#xD;
      moderator, and/or control variables. In addition, pain and stress parameters (both biological&#xD;
      and subjective) are being assessed at baseline, post-intervention and follow-up as well as in&#xD;
      the course of the ten music listening sessions. Furthermore, participants respond to specific&#xD;
      music and mood related items following each music listening session (e.g. perceived valence,&#xD;
      arousal, familiarity, liking, induced emotions, etc.).&#xD;
&#xD;
      It is hypothesized that listening to researcher-selected frequency-modulated music and&#xD;
      self-selected non-modulated music results in stronger increases in pain tolerance and&#xD;
      stronger decreases in pain intensity from baseline to post compared to listening to&#xD;
      researcher-selected non-modulated music. Furthermore, stronger decreases in stress parameters&#xD;
      (e.g. increases in HRV) from baseline to post are expected in the researcher-selected&#xD;
      frequency-modulated music and self-selected non-modulated music than in the&#xD;
      researcher-selected non-modulated music listening condition. Moreover, it is expected that&#xD;
      there will be no differences in researcher-selected frequency-modulated music and&#xD;
      self-selected non-modulated music with regards to pain and stress parameters. Additionally,&#xD;
      it will be tested whether changes in pain parameters are being mediated* by changes in&#xD;
      markers of stress-responsive systems (e.g. heart rate variability indices).&#xD;
&#xD;
      Finally, process analysis over the course of the music listening sessions sessions will be&#xD;
      conducted with biological and subjective pain and stress indices as well as music and mood&#xD;
      related parameters.&#xD;
&#xD;
      *Although checking for spelling mistakes before submitting the first record, a mistake in&#xD;
      wording was discovered only after the release of the record and therefore corrected&#xD;
      corresponding to our original hypothesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Tolerance</measure>
    <time_frame>Pre-Post-Change-Design: change from baseline to after 3 weeks</time_frame>
    <description>Cold pressor test (CPT): Duration in seconds from immersion of one hand into cold water until removal of the hand:&#xD;
baseline before music intervention&#xD;
post assessment after completion of music intervention (3 weeks)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>Pre-Post-Change-Design: change from baseline to after 3 weeks</time_frame>
    <description>Cold pressor test (CPT): Subjective pain intensity of the test rated via visual analog scale at the time of removal of the hand&#xD;
baseline assessment before music intervention&#xD;
post assessment after completion of music intervention (3 weeks)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Stress Experience</measure>
    <time_frame>Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention</time_frame>
    <description>visual analog scales&#xD;
baseline assessment (before and after CPT)&#xD;
post assessment after completion of music intervention (before and after CPT)&#xD;
in each music listening session (T1: before music listening, T2: after 60 minutes music listening, before CPT; T3: after CPT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Stress Experience</measure>
    <time_frame>Pre-Post-Change-Design: change from baseline to after 3 weeks</time_frame>
    <description>Measurements:&#xD;
chronic stress: SSCS (Screening scale of the TICS - Trier Inventory of Chronic Stress, assessed at baseline and post after completion of music intervention)&#xD;
stress reactivity: PSRS-23 (Perceived Stress Reactivity Scale, assessed at baseline and post after completion of music intervention)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological Stress: Heart Rate Variability Indices</measure>
    <time_frame>Pre-Post-Change-Design: change from baseline to after 3 weeks, process analysis during the course of the intervention</time_frame>
    <description>Various parameters (e.g. RMSSD, HF, LF, HF/LF)&#xD;
resting state assessed at baseline and post after completion of music intervention&#xD;
continuous assessment in each music listening session&#xD;
assessment in response to CPT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological Stress: Electrodermal activity (EDA)</measure>
    <time_frame>Pre-Post-Change-Design; change from baseline to after 3 weeks, process analysis during the course of the intervention</time_frame>
    <description>skin conductance level, skin conductance response&#xD;
resting state assessed at baseline and post after completion of music intervention&#xD;
continuous assessment in each music listening session&#xD;
assessment in response to CPT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological Stress: Hair Cortisol</measure>
    <time_frame>Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment</time_frame>
    <description>Hair Cortisol assessment:&#xD;
baseline before music intervention&#xD;
follow-up assessment 4 weeks after post assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fatigue</measure>
    <time_frame>Pre-Post-Change-Design; change from baseline to after 3 weeks</time_frame>
    <description>MFI-20 (Multidimensional Fatigue Inventory)&#xD;
baseline before music intervention&#xD;
post assessment after completion of music intervention (3 weeks)</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Pre-Follow Up-Change-Design; change from baseline to 4 weeks after post assessment</time_frame>
    <description>PSQI (Pittsburgh Sleep Quality Index)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Pain Perception</condition>
  <condition>Autonomic Nervous System Functioning</condition>
  <arm_group>
    <arm_group_label>researcher-selected frequency-modulated music</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>researcher-selected non-modulated music</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>participant-selected non-modulated music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>researcher-selected frequency-modulated music</intervention_name>
    <description>Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.</description>
    <arm_group_label>researcher-selected frequency-modulated music</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>researcher-selected non-modulated music</intervention_name>
    <description>The same music pieces as in the active comparator arm have been selected in advance by the researchers, but no artificial frequency modulation.</description>
    <arm_group_label>researcher-selected non-modulated music</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>participant-selected non-modulated music</intervention_name>
    <description>Participants bring their own choice of personally preferred music pieces and listen to them during the intervention sessions. There is no frequency modulation in this condition.</description>
    <arm_group_label>participant-selected non-modulated music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 18 - 35 years&#xD;
&#xD;
          -  BMI: 18.5 - 30 kg/m²&#xD;
&#xD;
          -  full command of the German language&#xD;
&#xD;
          -  capability to attend ten sessions of music listening in our laboratory within three&#xD;
             consecutive weeks, each for a duration of one hour&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  music related profession or studies&#xD;
&#xD;
          -  absolute hearing (self-report)&#xD;
&#xD;
          -  physical conditions (self-report): tinnitus, hearing impairments, extreme visual&#xD;
             impairment, cardiovascular diseases, diabetes, artery occlusive disease,&#xD;
             hyper-/hypotension, Raynaud syndrome, chronic pain condition&#xD;
&#xD;
          -  pregnancy, breastfeeding&#xD;
&#xD;
          -  current mental disorders (self-report): major depression, anxiety disorder, eating&#xD;
             disorder, substance dependence, psychosis, schizophrenia&#xD;
&#xD;
          -  regular intake of pain drugs/psychotropic drugs&#xD;
&#xD;
          -  not being able to refrain from smoking for 2.5 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urs Nater, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Urs Nater, PhD</last_name>
    <phone>0043 - 1 - 4277</phone>
    <phone_ext>47220</phone_ext>
    <email>urs.nater@univie.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Urs M Nater, PhD</last_name>
      <phone>+43-1-4277</phone>
      <phone_ext>47220</phone_ext>
      <email>urs.nater@univie.ac.at</email>
    </contact>
    <investigator>
      <last_name>Anja C Feneberg, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rosa M Maidhof, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Philipps-University Marburg, Department of Psychology, Clinical Biopsychology</name>
      <address>
        <city>Marburg</city>
        <state>Hessen</state>
        <zip>35037</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vienna</investigator_affiliation>
    <investigator_full_name>Urs Nater</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>music intervention</keyword>
  <keyword>heart rate variability</keyword>
  <keyword>frequency modulation</keyword>
  <keyword>pain perception</keyword>
  <keyword>cold pressor test (CPT)</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02991014
org study id: MINTREP-UN
nct id: NCT02991014
lead sponsor: 
has dmc: No
This study aims to compare the impact of listening to frequency-modulated music vs.
      non-modulated music (both researcher-selected), and to test whether there are differential
      effects on pain and stress perception. Further, these two conditions will be compared to a
      third condition, in which participants will be exposed to self-selected non-modulated music.
      It is hypothesized that both researcher-selected frequency-modulated music and self-selected
      non-modulated music result in stronger decreases in stress and pain compared to
      researcher-selected non-modulated music, while it is expected that there will be no
      differences in researcher-selected frequency-modulated music and self-selected non-modulated
      music. The intervention consists of ten sessions of music listening in the course of three
      consecutive weeks.
This study aims to compare the impact of three different music listening interventions on
      stress and pain parameters. Participants will be assigned randomly to one of the conditions.
      In order to avoid expectancy-related effects, participants in both the researcher- and
      self-selected condition are told that they were allocated randomly to frequency-modulated or
      non-modulated music. Therefore, subjects are fully blinded with regards to
      frequency-modulation.

      The study design is as follows:

        -  Baseline measurement: assessment of resting state biological parameters and
           questionnaires, CPT

        -  Music listening sessions: ten sessions in three consecutive weeks including:

             1. 60 minutes of music listening

             2. CPT following music listening (sessions 1, 3, 6, 10 only)

             3. Assessments: biological and subjective pain and stress parameters; music and mood
                related parameters

        -  Post measurement: assessment of resting state biological parameters and questionnaires,
           CPT

        -  Follow-up measurement: 4 weeks after intervention, assessment of resting state
           biological parameters and questionnaires, CPT

      Participants respond to health-related questions (chronic stress, stress reactivity, sleep
      quality, fatigue, menstrual cycle phase) as well as mood and music-related questions at
      baseline, post-intervention, and follow-up which are assessed as potential outcome,
      moderator, and/or control variables. In addition, pain and stress parameters (both biological
      and subjective) are being assessed at baseline, post-intervention and follow-up as well as in
      the course of the ten music listening sessions. Furthermore, participants respond to specific
      music and mood related items following each music listening session (e.g. perceived valence,
      arousal, familiarity, liking, induced emotions, etc.).

      It is hypothesized that listening to researcher-selected frequency-modulated music and
      self-selected non-modulated music results in stronger increases in pain tolerance and
      stronger decreases in pain intensity from baseline to post compared to listening to
      researcher-selected non-modulated music. Furthermore, stronger decreases in stress parameters
      (e.g. increases in HRV) from baseline to post are expected in the researcher-selected
      frequency-modulated music and self-selected non-modulated music than in the
      researcher-selected non-modulated music listening condition. Moreover, it is expected that
      there will be no differences in researcher-selected frequency-modulated music and
      self-selected non-modulated music with regards to pain and stress parameters. Additionally,
      it will be tested whether changes in pain parameters are being mediated* by changes in
      markers of stress-responsive systems (e.g. heart rate variability indices).

      Finally, process analysis over the course of the music listening sessions sessions will be
      conducted with biological and subjective pain and stress indices as well as music and mood
      related parameters.

      *Although checking for spelling mistakes before submitting the first record, a mistake in
      wording was discovered only after the release of the record and therefore corrected
      corresponding to our original hypothesis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain Tolerance
time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks
description: Cold pressor test (CPT): Duration in seconds from immersion of one hand into cold water until removal of the hand:
baseline before music intervention
post assessment after completion of music intervention (3 weeks)
measure: Pain Intensity
time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks
description: Cold pressor test (CPT): Subjective pain intensity of the test rated via visual analog scale at the time of removal of the hand
baseline assessment before music intervention
post assessment after completion of music intervention (3 weeks)
measure: Subjective Stress Experience
time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention
description: visual analog scales
baseline assessment (before and after CPT)
post assessment after completion of music intervention (before and after CPT)
in each music listening session (T1: before music listening, T2: after 60 minutes music listening, before CPT; T3: after CPT)
measure: Subjective Stress Experience
time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks
description: Measurements:
chronic stress: SSCS (Screening scale of the TICS - Trier Inventory of Chronic Stress, assessed at baseline and post after completion of music intervention)
stress reactivity: PSRS-23 (Perceived Stress Reactivity Scale, assessed at baseline and post after completion of music intervention)
measure: Physiological Stress: Heart Rate Variability Indices
time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks, process analysis during the course of the intervention
description: Various parameters (e.g. RMSSD, HF, LF, HF/LF)
resting state assessed at baseline and post after completion of music intervention
continuous assessment in each music listening session
assessment in response to CPT
measure: Physiological Stress: Electrodermal activity (EDA)
time frame: Pre-Post-Change-Design; change from baseline to after 3 weeks, process analysis during the course of the intervention
description: skin conductance level, skin conductance response
resting state assessed at baseline and post after completion of music intervention
continuous assessment in each music listening session
assessment in response to CPT
measure: Physiological Stress: Hair Cortisol
time frame: Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment
description: Hair Cortisol assessment:
baseline before music intervention
follow-up assessment 4 weeks after post assessment
measure: Fatigue
time frame: Pre-Post-Change-Design; change from baseline to after 3 weeks
description: MFI-20 (Multidimensional Fatigue Inventory)
baseline before music intervention
post assessment after completion of music intervention (3 weeks)
measure: Sleep Quality
time frame: Pre-Follow Up-Change-Design; change from baseline to 4 weeks after post assessment
description: PSQI (Pittsburgh Sleep Quality Index)
arm group label: researcher-selected frequency-modulated music
arm group type: Active Comparator
arm group label: researcher-selected non-modulated music
arm group type: Placebo Comparator
arm group label: participant-selected non-modulated music
arm group type: Experimental
intervention type: Behavioral
intervention name: researcher-selected frequency-modulated music
description: Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.
arm group label: researcher-selected frequency-modulated music
intervention type: Behavioral
intervention name: researcher-selected non-modulated music
description: The same music pieces as in the active comparator arm have been selected in advance by the researchers, but no artificial frequency modulation.
arm group label: researcher-selected non-modulated music
intervention type: Behavioral
intervention name: participant-selected non-modulated music
description: Participants bring their own choice of personally preferred music pieces and listen to them during the intervention sessions. There is no frequency modulation in this condition.
arm group label: participant-selected non-modulated music
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Urs Nater, PhD
role: Principal Investigator
affiliation: University of Vienna
last name: Urs Nater, PhD
phone: 0043 - 1 - 4277
phone ext: 47220
email: urs.nater@univie.ac.at
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
country: Austria
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Vienna
investigator full name: Urs Nater
investigator title: Prof. Dr.
sharing ipd: Undecided