<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/NCT01687907</url>
  </required_header>
  <id_info>
    <org_study_id>18/2.9.2009, 178/13/03/03/2009</org_study_id>
    <nct_id>NCT01687907</nct_id>
  </id_info>
  <brief_title>The Effects of Music on Fear of Childbirth and Outcome of Delivery</brief_title>
  <acronym>MUUSA</acronym>
  <official_title>A Randomized Longitudinal Trial About the Effects of Music on Fear of Childbirth and Outcome of Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <brief_summary>
    <textblock>
      The aim of this trial is to find out if active music listening during pregnancy and delivery&#xD;
      reliefs fear of childbirth, pain in delivery, need for analgesia during delivery and if there&#xD;
      is an effect on delivery complications. Also we try to find out if there is any influence on&#xD;
      mother-baby relationship.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Finland fear of childbirth is one of the common reasons for consultation of obstetrician&#xD;
      and mother´s demand on elective caesarean section. Approximately 5-8% of pregnant women&#xD;
      suffer from severe fear of childbirth, which disturbs their family-life and working and&#xD;
      prevents normal preparation to childbirth and parenthood.&#xD;
&#xD;
      Listening or playing music is very common in all cultures. Even fetuses are able to hear and&#xD;
      recognize music and babies are interested in voices and sounds of music.&#xD;
&#xD;
      Music therapy has been used in other purposes widely. It is known that music stimulates the&#xD;
      synthesis of dopamine in brain and it has been shown that music has an influence on&#xD;
      hypertensive rats, lowering their blood pressure. In human beings there has been pleasurable&#xD;
      responses to music correlate with activity in brain. It has also been shown that music&#xD;
      listening enhances cognitive recovery and mood after middle cerebral artery stroke.&#xD;
&#xD;
      A strong attachment between mother and infant is essential to child's normal developement.&#xD;
      Mothers who suffer from very strong fear of childbirth often have difficulties in&#xD;
      mother-infant relationship and pronounced risk of puerperal depression.&#xD;
&#xD;
      Many features in listening and playing music have something to do in bonding together in&#xD;
      societies. Lullabies are good example of communication between parent and infant.&#xD;
&#xD;
      There has been some trials about music therapy and pregnancy but not systematic randomized&#xD;
      trials about listening to music and its influence on pain experience, length of delivery or&#xD;
      complications of delivery. Music has a relaxing influence on human beings and we assume that&#xD;
      it has a positive influence on pregnant women also.&#xD;
&#xD;
      We try to find out if active listening to music has any influence on physical and mental&#xD;
      wellbeing of pregnant women or is there any influence on fear of childbirth, outcome of&#xD;
      delivery or mother-baby relationship.&#xD;
&#xD;
      Pregnant women referred to the outpatient clinic because of fear of childbirth have also&#xD;
      normal appointments with obstetrician and/or midwife as needed and participating this trial&#xD;
      has no influence on those appointments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2009</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>spontaneous vaginal delivery</measure>
    <time_frame>day of delivery</time_frame>
    <description>delivery data collected from the patient records afterwards</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delivery satisfaction</measure>
    <time_frame>within three days after delivery (before leaving the postpartum ward)</time_frame>
    <description>specific questionnaires</description>
  </secondary_outcome>
  <other_outcome>
    <measure>early mother-infant relationship</measure>
    <time_frame>6 months after delivery</time_frame>
    <description>specific questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>mental wellbeing</measure>
    <time_frame>during pregnancy and up to 6 months after delivery</time_frame>
    <description>specific questionnaires and diaries</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Fear of Childbirth</condition>
  <arm_group>
    <arm_group_label>Fear of childbirth, music</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients referred to the motherhood out-patient clinic because of fear of childbirth. Advised to active music listening. Followed up by weekly and monthly diaries and three questionnaires (when recruiting, just after the delivery and 6 months after the delivery).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fear of childbirth, control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients referred to the motherhood out-patient clinic because of fear of childbirth. No intervention. Followed up by three questionnaires (when recruiting, just after the delivery and 6 months after the delivery).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nulliparous, music</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>300 nulliparous women recruited from the ultrasound screening. Advised to active music listening. Three questionnaires like the other arms, weekly and monthly diaries like the other music group. Screening questionnaires about fear of childbirth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nulliparous, control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>300 nulliparous women recruited from ultrasound screening. No intervention. 3 Questionnaires as all the other groups. Screening questionnaire about fear of childbirth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music</intervention_name>
    <arm_group_label>Fear of childbirth, music</arm_group_label>
    <arm_group_label>Nulliparous, music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fear of childbirth in arms 1 and 2,&#xD;
&#xD;
          -  nulliparous in arms 3 and 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not able to answer the questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terhi Saisto, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Assi Sten, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Assi Sten, MD</last_name>
    <phone>+358504284700</phone>
    <email>assi.sten@helsinki.fi, assi.sten@hus.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Terhi Saisto, MD,PhD</last_name>
    <email>terhi.saisto@hus.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <state>HUS</state>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Assi Sten, MD</last_name>
      <phone>+358504284700</phone>
      <email>assi.sten@helsinki.fi, assi.sten@hus.fi</email>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 15, 2012</last_update_submitted>
  <last_update_submitted_qc>September 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Assi Sten</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>fear of childbirth</keyword>
  <keyword>outcome of delivery</keyword>
  <keyword>music</keyword>
  <keyword>mother-baby relationship</keyword>
  <!-- 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/NCT01687907
org study id: 18/2.9.2009, 178/13/03/03/2009
nct id: NCT01687907
lead sponsor: 
The aim of this trial is to find out if active music listening during pregnancy and delivery
      reliefs fear of childbirth, pain in delivery, need for analgesia during delivery and if there
      is an effect on delivery complications. Also we try to find out if there is any influence on
      mother-baby relationship.
In Finland fear of childbirth is one of the common reasons for consultation of obstetrician
      and mother´s demand on elective caesarean section. Approximately 5-8% of pregnant women
      suffer from severe fear of childbirth, which disturbs their family-life and working and
      prevents normal preparation to childbirth and parenthood.

      Listening or playing music is very common in all cultures. Even fetuses are able to hear and
      recognize music and babies are interested in voices and sounds of music.

      Music therapy has been used in other purposes widely. It is known that music stimulates the
      synthesis of dopamine in brain and it has been shown that music has an influence on
      hypertensive rats, lowering their blood pressure. In human beings there has been pleasurable
      responses to music correlate with activity in brain. It has also been shown that music
      listening enhances cognitive recovery and mood after middle cerebral artery stroke.

      A strong attachment between mother and infant is essential to child's normal developement.
      Mothers who suffer from very strong fear of childbirth often have difficulties in
      mother-infant relationship and pronounced risk of puerperal depression.

      Many features in listening and playing music have something to do in bonding together in
      societies. Lullabies are good example of communication between parent and infant.

      There has been some trials about music therapy and pregnancy but not systematic randomized
      trials about listening to music and its influence on pain experience, length of delivery or
      complications of delivery. Music has a relaxing influence on human beings and we assume that
      it has a positive influence on pregnant women also.

      We try to find out if active listening to music has any influence on physical and mental
      wellbeing of pregnant women or is there any influence on fear of childbirth, outcome of
      delivery or mother-baby relationship.

      Pregnant women referred to the outpatient clinic because of fear of childbirth have also
      normal appointments with obstetrician and/or midwife as needed and participating this trial
      has no influence on those appointments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: spontaneous vaginal delivery
time frame: day of delivery
description: delivery data collected from the patient records afterwards
measure: Delivery satisfaction
time frame: within three days after delivery (before leaving the postpartum ward)
description: specific questionnaires
measure: early mother-infant relationship
time frame: 6 months after delivery
description: specific questionnaires
measure: mental wellbeing
time frame: during pregnancy and up to 6 months after delivery
description: specific questionnaires and diaries
arm group label: Fear of childbirth, music
arm group type: Active Comparator
description: Patients referred to the motherhood out-patient clinic because of fear of childbirth. Advised to active music listening. Followed up by weekly and monthly diaries and three questionnaires (when recruiting, just after the delivery and 6 months after the delivery).
arm group label: Fear of childbirth, control
arm group type: No Intervention
description: Patients referred to the motherhood out-patient clinic because of fear of childbirth. No intervention. Followed up by three questionnaires (when recruiting, just after the delivery and 6 months after the delivery).
arm group label: Nulliparous, music
arm group type: Active Comparator
description: 300 nulliparous women recruited from the ultrasound screening. Advised to active music listening. Three questionnaires like the other arms, weekly and monthly diaries like the other music group. Screening questionnaires about fear of childbirth.
arm group label: Nulliparous, control
arm group type: No Intervention
description: 300 nulliparous women recruited from ultrasound screening. No intervention. 3 Questionnaires as all the other groups. Screening questionnaire about fear of childbirth.
intervention type: Behavioral
intervention name: Music
arm group label: Fear of childbirth, music
arm group label: Nulliparous, music
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Terhi Saisto, MD,PhD
role: Study Director
affiliation: Helsinki University Central Hospital
last name: Assi Sten, MD
role: Principal Investigator
affiliation: Helsinki University Central Hospital
last name: Assi Sten, MD
phone: +358504284700
email: assi.sten@helsinki.fi, assi.sten@hus.fi
last name: Terhi Saisto, MD,PhD
email: terhi.saisto@hus.fi
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Assi Sten
investigator title: Principal investigator