<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/NCT03028844</url>
  </required_header>
  <id_info>
    <org_study_id>ED/01/16UCC</org_study_id>
    <nct_id>NCT03028844</nct_id>
  </id_info>
  <brief_title>The Effect of a Musical Intervention on Stress Response to Venepuncture</brief_title>
  <official_title>The Effect of a Musical Intervention on Stress Response to Venepuncture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College Cork</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College Cork</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and&#xD;
      sucrose versus sucrose on stress&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess whether the use of music therapy as a&#xD;
      non-pharmacological intervention around the time of venepuncture significantly decreases the&#xD;
      stress response of a stable preterm neonate, as measured by salivary cortisol levels .&#xD;
&#xD;
      The secondary aim of this study is to analyse the effect of music therapy on the EEG, and&#xD;
      vital signs of the stable preterm neonate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Salivary cortisol levels</measure>
    <time_frame>BASELINE, 20 mins and 4 hours</time_frame>
    <description>Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Premature Infant Pain Profile (PIPP) score</measure>
    <time_frame>immediate</time_frame>
    <description>Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physiological parameters - Heart rate</measure>
    <time_frame>10 mins before venepuncture and 10 mins after</time_frame>
    <description>Increase in heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physiological parameters - respiration rate</measure>
    <time_frame>10 mins before venepuncture and 10 mins after</time_frame>
    <description>Increase in respiration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physiological parameters - oxygen saturation</measure>
    <time_frame>10 mins before venepuncture and 10 mins after</time_frame>
    <description>Decrease in oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physiological parameters - EEG</measure>
    <time_frame>10 mins before venepuncture and 10 mins after</time_frame>
    <description>Altered EEG amplitude and Frequency.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Pain</condition>
  <condition>Stress, Physiological</condition>
  <arm_group>
    <arm_group_label>Sucrose alone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These infants will receive an oral sucrose solution (&quot;Sweetease&quot;) only prior to venepuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Music intervention plus sucrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These infants will receive both oral sucrose solution and music therapy prior to venepuncture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music therapy</intervention_name>
    <description>The musical intervention will be played for ten minutes prior to venepuncture</description>
    <arm_group_label>Music intervention plus sucrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born at less than 32 weeks gestational age (from 23+0 weeks' up to and&#xD;
             including 31+6 weeks' gestational age)&#xD;
&#xD;
          -  Infants must now be &gt;32 weeks corrected gestational age&#xD;
&#xD;
          -  Infants who are medically stable and due to have routine venepuncture as part of their&#xD;
             management plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to obtain informed consent from parent&#xD;
&#xD;
          -  Infants with known hearing impairment&#xD;
&#xD;
          -  Infants receiving sedative medications&#xD;
&#xD;
          -  Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis&#xD;
&#xD;
          -  Infants with congenital abnormalities&#xD;
&#xD;
          -  Infants with known EEG abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Weeks</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cork University Maternity Hospital</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College Cork</investigator_affiliation>
    <investigator_full_name>Dr. Gene Dempsey</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <keyword>Neonate</keyword>
  <keyword>preterm</keyword>
  <keyword>pain</keyword>
  <keyword>music</keyword>
  <keyword>EEG</keyword>
  <keyword>venepuncture</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/NCT03028844
org study id: ED/01/16UCC
nct id: NCT03028844
lead sponsor: 
has dmc: No
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and
      sucrose versus sucrose on stress
The purpose of this study is to assess whether the use of music therapy as a
      non-pharmacological intervention around the time of venepuncture significantly decreases the
      stress response of a stable preterm neonate, as measured by salivary cortisol levels .

      The secondary aim of this study is to analyse the effect of music therapy on the EEG, and
      vital signs of the stable preterm neonate.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Salivary cortisol levels
time frame: BASELINE, 20 mins and 4 hours
description: Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours
measure: Premature Infant Pain Profile (PIPP) score
time frame: immediate
description: Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score
measure: Changes in physiological parameters - Heart rate
time frame: 10 mins before venepuncture and 10 mins after
description: Increase in heart rate
measure: Changes in physiological parameters - respiration rate
time frame: 10 mins before venepuncture and 10 mins after
description: Increase in respiration rate
measure: Changes in physiological parameters - oxygen saturation
time frame: 10 mins before venepuncture and 10 mins after
description: Decrease in oxygen saturation
measure: Changes in physiological parameters - EEG
time frame: 10 mins before venepuncture and 10 mins after
description: Altered EEG amplitude and Frequency.
arm group label: Sucrose alone
arm group type: No Intervention
description: These infants will receive an oral sucrose solution ("Sweetease") only prior to venepuncture
arm group label: Music intervention plus sucrose
arm group type: Experimental
description: These infants will receive both oral sucrose solution and music therapy prior to venepuncture.
intervention type: Other
intervention name: Music therapy
description: The musical intervention will be played for ten minutes prior to venepuncture
arm group label: Music intervention plus sucrose
criteria: 
gender: All
minimum age: 23 Weeks
maximum age: 32 Weeks
healthy volunteers: No
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: University College Cork
investigator full name: Dr. Gene Dempsey
investigator title: Prof
sharing ipd: No