<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/NCT03779386</url>
  </required_header>
  <id_info>
    <org_study_id>278/18</org_study_id>
    <nct_id>NCT03779386</nct_id>
  </id_info>
  <brief_title>Trial of Music During Labor and Delivery</brief_title>
  <official_title>Music During Labor and Delivery: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of music is widely supported in various areas of medicine: first of all in the&#xD;
      psychiatric field as in the treatment of autism in children, obtaining surprising results&#xD;
      even on Alzheimer's patients, or the unparalleled effect of music on those suffering from&#xD;
      depression. To strengthen the thesis of the usefulness of music in medicine there is what is&#xD;
      called PNEI, or the psychoneuroendocrinoimmunology. This discipline consists in the study of&#xD;
      mutual interactions between mental activity, behavior, nervous system, endocrine system and&#xD;
      immune reactivity. The PNEI itself no longer pays attention to the mind with respect to the&#xD;
      body, but using the principles of the empirical epistemology of the scientific method strives&#xD;
      to clarify those connections that make the nervous system, mind, immunity and hormonal&#xD;
      regulation a unique and complex homeostatic control system of the individual, whose synergism&#xD;
      would be able to modify certain biological behaviors, such as the transition from a distress&#xD;
      to an eustress. This passage would seem to be of particular obstetric interest going to&#xD;
      significantly change the course of labor in terms of pain, anxiety and well-being of women.&#xD;
      In fact, many women prefer not to resort to partoanalgesia and famaci for pain control during&#xD;
      labor.&#xD;
&#xD;
      A recent Cochrane Review analyzed the effectiveness of music in the control of pain in labor,&#xD;
      confirming its role in this sense. However, he concluded that the quality of available&#xD;
      evidence varied from low to very low, thus highlighting the need for further studies in this&#xD;
      area.&#xD;
&#xD;
      Thus, the present study arises with the rational to satisfy this need for further&#xD;
      investigation into the positive effects of music on pain in women in labor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2018</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain during the active phase</measure>
    <time_frame>during the labor</time_frame>
    <description>pain assessed with VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>anxiety during the active phase, second stage, and postpartum</measure>
    <time_frame>during the labor</time_frame>
    <description>assessed with VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain during second stage, and during postpartum</measure>
    <time_frame>during the labor</time_frame>
    <description>pain assessed with VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postpartum depression</measure>
    <time_frame>at the time of delivery</time_frame>
    <description>incidence of postpartum depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>episiotomy and lacerations</measure>
    <time_frame>at the time of delivery</time_frame>
    <description>incidence of episiotomy and lacerations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesia</measure>
    <time_frame>at the time of delivery</time_frame>
    <description>use of analgesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>labor length</measure>
    <time_frame>during labor</time_frame>
    <description>length of first stage, and second stage of labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neonatal outcomes</measure>
    <time_frame>at the time of delivery until 28days of life</time_frame>
    <description>admission to NICU, neonatal death, a composite of outcomes including NEC, IVH, RDS, BPD, ROP, sepsis, N1CU and death. Multiple measurements (i.e. for composite perinatal outcome) will be aggregated to arrive at one reported value (i.e. incidence of composite perianatal outcome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>Music during labor and delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music during labor and delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No music during labor and delivery</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No music during labor and delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>music</intervention_name>
    <description>music during labor and delivery</description>
    <arm_group_label>Music during labor and delivery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton gestations;&#xD;
&#xD;
          -  term of phisiological pregnancy&#xD;
&#xD;
          -  spontaneous labor&#xD;
&#xD;
          -  diagnosis of active phase of labor;&#xD;
&#xD;
          -  nulliparous between 37 and 42 gestation weeks with cephalic presentation ;&#xD;
&#xD;
          -  maternal age between 18 and 45 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple gestations;&#xD;
&#xD;
          -  preterm labor;&#xD;
&#xD;
          -  preterm premature rupture of membranes&#xD;
&#xD;
          -  induction to delivery labor;&#xD;
&#xD;
          -  Hipertensive disorders;&#xD;
&#xD;
          -  fetal abnormalities;&#xD;
&#xD;
          -  diabetes mellitus;&#xD;
&#xD;
          -  intrauterine growth retardation;&#xD;
&#xD;
          -  post-term pregnancy;&#xD;
&#xD;
          -  multiple vaginal delivery;&#xD;
&#xD;
          -  women with an altered state of consciousness, severely ill, mentally disabled;&#xD;
&#xD;
          -  women who are unconscious, severly ill, mentally handicapped;&#xD;
&#xD;
          -  women under the age of 18 years or over the age of 45 years.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gabriele Saccone</name>
      <address>
        <city>Napoli</city>
        <zip>80129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Gabriele Saccone</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <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/NCT03779386
org study id: 278/18
nct id: NCT03779386
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of music is widely supported in various areas of medicine: first of all in the
      psychiatric field as in the treatment of autism in children, obtaining surprising results
      even on Alzheimer's patients, or the unparalleled effect of music on those suffering from
      depression. To strengthen the thesis of the usefulness of music in medicine there is what is
      called PNEI, or the psychoneuroendocrinoimmunology. This discipline consists in the study of
      mutual interactions between mental activity, behavior, nervous system, endocrine system and
      immune reactivity. The PNEI itself no longer pays attention to the mind with respect to the
      body, but using the principles of the empirical epistemology of the scientific method strives
      to clarify those connections that make the nervous system, mind, immunity and hormonal
      regulation a unique and complex homeostatic control system of the individual, whose synergism
      would be able to modify certain biological behaviors, such as the transition from a distress
      to an eustress. This passage would seem to be of particular obstetric interest going to
      significantly change the course of labor in terms of pain, anxiety and well-being of women.
      In fact, many women prefer not to resort to partoanalgesia and famaci for pain control during
      labor.

      A recent Cochrane Review analyzed the effectiveness of music in the control of pain in labor,
      confirming its role in this sense. However, he concluded that the quality of available
      evidence varied from low to very low, thus highlighting the need for further studies in this
      area.

      Thus, the present study arises with the rational to satisfy this need for further
      investigation into the positive effects of music on pain in women in labor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain during the active phase
time frame: during the labor
description: pain assessed with VAS
measure: anxiety during the active phase, second stage, and postpartum
time frame: during the labor
description: assessed with VAS
measure: pain during second stage, and during postpartum
time frame: during the labor
description: pain assessed with VAS
measure: postpartum depression
time frame: at the time of delivery
description: incidence of postpartum depression
measure: episiotomy and lacerations
time frame: at the time of delivery
description: incidence of episiotomy and lacerations
measure: analgesia
time frame: at the time of delivery
description: use of analgesia
measure: labor length
time frame: during labor
description: length of first stage, and second stage of labor
measure: neonatal outcomes
time frame: at the time of delivery until 28days of life
description: admission to NICU, neonatal death, a composite of outcomes including NEC, IVH, RDS, BPD, ROP, sepsis, N1CU and death. Multiple measurements (i.e. for composite perinatal outcome) will be aggregated to arrive at one reported value (i.e. incidence of composite perianatal outcome)
arm group label: Music during labor and delivery
arm group type: Experimental
description: Music during labor and delivery
arm group label: No music during labor and delivery
arm group type: No Intervention
description: No music during labor and delivery
intervention type: Other
intervention name: music
description: music during labor and delivery
arm group label: Music during labor and delivery
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Gabriele Saccone
investigator title: Principal Investigator
mesh term: Labor Pain
sharing ipd: No