<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/NCT02999542</url>
  </required_header>
  <id_info>
    <org_study_id>451/2016</org_study_id>
    <nct_id>NCT02999542</nct_id>
  </id_info>
  <brief_title>Effect of Music on Emergence Delirium</brief_title>
  <official_title>The Effect of Intraoperative Music on the Prevalence and Severity of Emergence Delirium in Paediatric Patients: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pretoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pretoria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers are conducting a research study to see whether listening to music during an&#xD;
      operation will have a positive effect on the way that children wake up from&#xD;
      surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and&#xD;
      screaming (known as emergence delirium). Research have shown that music decreases anxiety and&#xD;
      pain. The researchers want to see whether music can also influence a child's behaviour after&#xD;
      emerging from anaesthesia. In other words whether they will be more calm and cooperative&#xD;
      after listening to music while they are asleep during surgery. Should music have a positive&#xD;
      effect, anaesthesiologists may use it in future to improve care of patients coming for&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children coming for certain elective surgeries, where pain has been excluded as a confounding&#xD;
      factor, will have headphones placed on their ears after induction of anaesthesia. They will&#xD;
      be randomised to two groups, one will receive music and the other just silence. The&#xD;
      headphones will be removed just before waking the patient up. In the recovery room the&#xD;
      child's behaviour will be observed and will be scored according to a validated score. The two&#xD;
      groups will then be compared to see whether music makes a difference to the behaviour after&#xD;
      anaesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of music on the prevalence of emergence delirium in paediatric patients</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect of music therapy on the severity of emergence delirium in paediatric patients.</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Emergence Delirium</condition>
  <arm_group>
    <arm_group_label>Music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will receive music via headphones</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will listen to silence via headphones</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music</intervention_name>
    <description>Children will be randomised to receive either music via headphones or silence via headphones</description>
    <arm_group_label>Music</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No music</intervention_name>
    <description>Children will be randomised to receive either music via headphones or silence via headphones</description>
    <arm_group_label>No music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 2-7 years&#xD;
&#xD;
          -  American society of anaesthesiologists class I and II patients&#xD;
&#xD;
          -  Child has adequate hearing&#xD;
&#xD;
          -  Surgery or procedure under general anaesthesia&#xD;
&#xD;
          -  Receiving standardised anaesthetic&#xD;
&#xD;
          -  Type of surgeries included: orthopaedic, urological, paediatric surgery and&#xD;
             ophthalmology&#xD;
&#xD;
          -  Minimum exposure to music must be 15minutes&#xD;
&#xD;
          -  Child may not receive any premedication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American society of Anaesthesiologists class 3 and above&#xD;
&#xD;
          -  Emergency cases&#xD;
&#xD;
          -  Children with hearing problems&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pretoria</investigator_affiliation>
    <investigator_full_name>DR. Michelle Olivier</investigator_full_name>
    <investigator_title>DR</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <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/NCT02999542
org study id: 451/2016
nct id: NCT02999542
lead sponsor: 
has dmc: Yes
The researchers are conducting a research study to see whether listening to music during an
      operation will have a positive effect on the way that children wake up from
      surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and
      screaming (known as emergence delirium). Research have shown that music decreases anxiety and
      pain. The researchers want to see whether music can also influence a child's behaviour after
      emerging from anaesthesia. In other words whether they will be more calm and cooperative
      after listening to music while they are asleep during surgery. Should music have a positive
      effect, anaesthesiologists may use it in future to improve care of patients coming for
      surgery.
Children coming for certain elective surgeries, where pain has been excluded as a confounding
      factor, will have headphones placed on their ears after induction of anaesthesia. They will
      be randomised to two groups, one will receive music and the other just silence. The
      headphones will be removed just before waking the patient up. In the recovery room the
      child's behaviour will be observed and will be scored according to a validated score. The two
      groups will then be compared to see whether music makes a difference to the behaviour after
      anaesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: The effect of music on the prevalence of emergence delirium in paediatric patients
time frame: Up to 12 months
measure: The effect of music therapy on the severity of emergence delirium in paediatric patients.
time frame: Up to 12 months
arm group label: Music
arm group type: Experimental
description: Children will receive music via headphones
arm group label: No music
arm group type: Experimental
description: Children will listen to silence via headphones
intervention type: Other
intervention name: Music
description: Children will be randomised to receive either music via headphones or silence via headphones
arm group label: Music
intervention type: Other
intervention name: No music
description: Children will be randomised to receive either music via headphones or silence via headphones
arm group label: No music
criteria: 
gender: All
minimum age: 2 Years
maximum age: 7 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Pretoria
investigator full name: DR. Michelle Olivier
investigator title: DR
mesh term: Delirium
mesh term: Emergence Delirium
sharing ipd: Undecided