xml: <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/NCT06003946</url>
    </required_header>
    <id_info>
      <org_study_id>2023 - 000183124</org_study_id>
      <secondary_id>ZHAW</secondary_id>
      <secondary_id>UZH</secondary_id>
      <nct_id>NCT06003946</nct_id>
    </id_info>
    <brief_title>Effectiveness of a Breathing and Relaxation Technique in Antenatal Education</brief_title>
    <acronym>BreLax</acronym>
    <official_title>Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax Study): a Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zurich University of Applied Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Zurich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Zurich University of Applied Sciences</source>
    <oversight_info>
      <has_dmc>Yes</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 aim of this randomised controlled trial is to compare the effects of an antenatal&#xD;
        education class including a breathing and relaxation technique on self-efficacy compared to a&#xD;
        standard antenatal education class without a focus on breathing and relaxation techniques.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Antenatal education classes were developed to inform expectant mothers about pregnancy,&#xD;
        labour and birth and the postpartum period with the aim of improving pregnancy and childbirth&#xD;
        experience. They were based, for example, on concepts of Lamaze and Grantly Dick-Read.&#xD;
        Studies indicate positive emotional effects on labour and birth outcomes in women who&#xD;
        attended antenatal education classes. This includes lower levels of fear of childbirth, lower&#xD;
        rates of caesarean birth at the women's request, a higher rate of spontaneous births, and a&#xD;
        stronger involvement of the partner, better chances of initiating breastfeeding, a lower&#xD;
        likelihood of developing depression symptoms during the postpartum period. There is limited&#xD;
        evidence on the link between birth preparation and neonatal outcomes. Considering recent&#xD;
        evidence suggesting that antenatal education classes may positively influence maternal and&#xD;
        neonatal birth outcomes, we intend to analyse an antenatal education class focusing on a&#xD;
        breathing and relaxation technique and assess the impact of such a class on self-efficacy, as&#xD;
        well as other maternal and neonatal birth outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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 (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Self-efficacy</measure>
      <time_frame>13 weeks till 37 weeks of pregnancy</time_frame>
      <description>Changes from baseline to after the antenatal education class measured with the german version of the childbirth self-efficacy inventory (CBSEI).&#xD;
  The CBSEI is a 32-item scale that measures women's perceived self-efficacy towards labour. Items are scored on a scale of 1 to 10. A higher score indicates that participants are better able to cope with difficult tasks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Childbirth experience</measure>
      <time_frame>within 4 weeks after birth</time_frame>
      <description>Birth experience is assessed after birth using the german version of the childbirth experience questionnaire (CEQ 2.0) The CEQ 2.0 is a 25-item scale with four dimensions (own capacity, perceived safety, professional support and participation). Items are scored on a scale of 1 (disagree at all) to 4 (agree completely). A higher value indicates a more positive assessment of the birth experience.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain management</measure>
      <time_frame>within 4 weeks after birth</time_frame>
      <description>epidural anesthesia (PDA) yes/no, nitrous oxide yes/no, Patient Controlled Analgesia (PCA) yes/no, other pain medication yes/no (medical birth record)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>birthing position</measure>
      <time_frame>within 4 weeks after birth</time_frame>
      <description>Documented during labour and birth (medical birth record). elevated supine yes/no, lateral position yes/no, standing yes/no, 4-foot position yes/no, bathtub yes/no, sitting (stool) yes/no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of labour</measure>
      <time_frame>within 4 weeks after birth</time_frame>
      <description>Documented during labour and birth (medical birth record)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bonding</measure>
      <time_frame>within 4 weeks after birth</time_frame>
      <description>Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-minute Apgar-Score</measure>
      <time_frame>within 4 weeks after birth</time_frame>
      <description>Documented during labour and birth (medical birth record). Appearance 0 to 2 (pale/ trunk rosy, extremities pale/ rosy), Pulse 0 to 2 (no Puls/ &lt;100/min/ &gt;100/min), Grimace 0 to 2 (No/ Grimacing/ Screaming), Activity 0 to 2 (Flaccid/ Sluggish flexion movements/ Spontaneous good self-movement), Respiration 0 to 2 (None/ Slow, irregular breathing or gasping/ Regular (40/min)). Interpretation: normal: 9-10 points; marginal: 5-8 points; critical for the newborn: &lt;5 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>arterial umbilical cord pH</measure>
      <time_frame>within 4 weeks after birth</time_frame>
      <description>Documented after labour and birth (medical birth record). Normal values in the umbilical artery blood are values of 7.20 - 7.38. At pH below 7.2 there is mild acidosis, below 7.1 moderate acidosis and below 7.0 severe acidosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility and effectiveness BreLax</measure>
      <time_frame>13 weeks of pregnancy till 4 weeks after birth</time_frame>
      <description>Self-reported by participants (digital diary and questionnaire). How often practiced before birth (text), how long practiced each time (Text) , where practiced (Text) , when used during birth (contractions irregular yes/no, contractions regular yes/no, at end of birth (pushing phase) yes/no, whole birth) yes/no.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Pregnancy</condition>
    <arm_group>
      <arm_group_label>Intervention group (BreLax)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BreLax: midwife-led antenatal education class</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group (Standard care)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Midwife-led antenatal education class</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>BreLax: Antenatal education class</intervention_name>
      <description>An antenatal education class over 9 hours with information regarding pregnancy, labour and birth, pain management as well as the postpartum period with an integrated breathing and relaxation technique (prolonged exhalation in the individual rhythm) and 4 accompanying positions (standing upright, sitting supported, four-footed, supported lying on the side). In addition, participants receive a manual for independent practice at home.</description>
      <arm_group_label>Intervention group (BreLax)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard care (control)</intervention_name>
      <description>An antenatal education class over 9 hours, with information regarding pregnancy, labour and birth, pain management and the postpartum period as well as some relaxation exercises.</description>
      <arm_group_label>Control group (Standard care)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pregnant women with a singleton low-risk pregnancy&#xD;
  &#xD;
            -  receiving antenatal care&#xD;
  &#xD;
            -  being willing to attend an antenatal education class&#xD;
  &#xD;
            -  planning a vaginal birth&#xD;
  &#xD;
            -  sufficient oral and written German language knowledge&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  women, who plan an elective caesarean section&#xD;
  &#xD;
            -  pregnant with multiples&#xD;
  &#xD;
            -  do not have sufficient oral and written German language knowledge&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Vanessa Leutenegger, RM, MScN</last_name>
      <phone>+41589344369</phone>
      <email>vanessa.leutenegger@zhaw.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zurich University of Applied Sciences</name>
        <address>
          <city>Winterthur</city>
          <state>Zurich</state>
          <zip>8400</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Vanessa Leutenegger, RM, MScN, PhD Student</last_name>
        <phone>+41589344369</phone>
        <email>vanessa.leutenegger@zhaw.ch</email>
      </contact>
      <investigator>
        <last_name>Vanessa Leutenegger, RM, MScN, PhD Student</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <reference>
      <citation>Shand AW, Lewis-Jones B, Nielsen T, Svensson J, Lainchbury A, Henry A, Nassar N. Birth outcomes by type of attendance at antenatal education: An observational study. Aust N Z J Obstet Gynaecol. 2022 Dec;62(6):859-867. doi: 10.1111/ajo.13541. Epub 2022 May 17.</citation>
      <PMID>35581951</PMID>
    </reference>
    <reference>
      <citation>Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Saisto T. Obstetric outcome after intervention for severe fear of childbirth in nulliparous women - randomised trial. BJOG. 2013 Jan;120(1):75-84. doi: 10.1111/1471-0528.12011. Epub 2012 Nov 2.</citation>
      <PMID>23121002</PMID>
    </reference>
    <reference>
      <citation>Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009 Apr;25(2):114-25. doi: 10.1016/j.midw.2006.12.012. Epub 2007 Apr 24.</citation>
      <PMID>17459542</PMID>
    </reference>
    <reference>
      <citation>Svensson J, Barclay L, Cooke M. Effective antenatal education: strategies recommended by expectant and new parents. J Perinat Educ. 2008 Fall;17(4):33-42. doi: 10.1624/105812408X364152.</citation>
      <PMID>19436529</PMID>
    </reference>
    <reference>
      <citation>Ip WY, Tang CS, Goggins WB. An educational intervention to improve women's ability to cope with childbirth. J Clin Nurs. 2009 Aug;18(15):2125-35. doi: 10.1111/j.1365-2702.2008.02720.x.</citation>
      <PMID>19583645</PMID>
    </reference>
    <reference>
      <citation>Ahlden I, Ahlehagen S, Dahlgren LO, Josefsson A. Parents' expectations about participating in antenatal parenthood education classes. J Perinat Educ. 2012 Winter;21(1):11-7. doi: 10.1891/1058-1243.21.1.11.</citation>
      <PMID>23277726</PMID>
    </reference>
    <reference>
      <citation>Schmidt G, Stoll K, Jager B, Gross MM. [German Version of the Childbirth Self-Efficacy Inventory and its Short Form]. Z Geburtshilfe Neonatol. 2016 Feb;220(1):28-34. doi: 10.1055/s-0035-1547296. Epub 2015 Sep 17. German.</citation>
      <PMID>26378776</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zurich University of Applied Sciences</investigator_affiliation>
      <investigator_full_name>Vanessa Leutenegger</investigator_full_name>
      <investigator_title>PhD Student</investigator_title>
    </responsible_party>
    <keyword>breathing technique</keyword>
    <keyword>birth preparation</keyword>
    <keyword>prenatal education</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003946
  org study id: 2023 - 000183124
  secondary id: ZHAW
  secondary id: UZH
  nct id: NCT06003946
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this randomised controlled trial is to compare the effects of an antenatal
        education class including a breathing and relaxation technique on self-efficacy compared to a
        standard antenatal education class without a focus on breathing and relaxation techniques.
  Antenatal education classes were developed to inform expectant mothers about pregnancy,
        labour and birth and the postpartum period with the aim of improving pregnancy and childbirth
        experience. They were based, for example, on concepts of Lamaze and Grantly Dick-Read.
        Studies indicate positive emotional effects on labour and birth outcomes in women who
        attended antenatal education classes. This includes lower levels of fear of childbirth, lower
        rates of caesarean birth at the women's request, a higher rate of spontaneous births, and a
        stronger involvement of the partner, better chances of initiating breastfeeding, a lower
        likelihood of developing depression symptoms during the postpartum period. There is limited
        evidence on the link between birth preparation and neonatal outcomes. Considering recent
        evidence suggesting that antenatal education classes may positively influence maternal and
        neonatal birth outcomes, we intend to analyse an antenatal education class focusing on a
        breathing and relaxation technique and assess the impact of such a class on self-efficacy, as
        well as other maternal and neonatal birth outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Self-efficacy
  time frame: 13 weeks till 37 weeks of pregnancy
  description: Changes from baseline to after the antenatal education class measured with the german version of the childbirth self-efficacy inventory (CBSEI).
  The CBSEI is a 32-item scale that measures women's perceived self-efficacy towards labour. Items are scored on a scale of 1 to 10. A higher score indicates that participants are better able to cope with difficult tasks.
  measure: Childbirth experience
  time frame: within 4 weeks after birth
  description: Birth experience is assessed after birth using the german version of the childbirth experience questionnaire (CEQ 2.0) The CEQ 2.0 is a 25-item scale with four dimensions (own capacity, perceived safety, professional support and participation). Items are scored on a scale of 1 (disagree at all) to 4 (agree completely). A higher value indicates a more positive assessment of the birth experience.
  measure: pain management
  time frame: within 4 weeks after birth
  description: epidural anesthesia (PDA) yes/no, nitrous oxide yes/no, Patient Controlled Analgesia (PCA) yes/no, other pain medication yes/no (medical birth record)
  measure: birthing position
  time frame: within 4 weeks after birth
  description: Documented during labour and birth (medical birth record). elevated supine yes/no, lateral position yes/no, standing yes/no, 4-foot position yes/no, bathtub yes/no, sitting (stool) yes/no
  measure: Duration of labour
  time frame: within 4 weeks after birth
  description: Documented during labour and birth (medical birth record)
  measure: Bonding
  time frame: within 4 weeks after birth
  description: Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no
  measure: 5-minute Apgar-Score
  time frame: within 4 weeks after birth
  description: Documented during labour and birth (medical birth record). Appearance 0 to 2 (pale/ trunk rosy, extremities pale/ rosy), Pulse 0 to 2 (no Puls/ <100/min/ >100/min), Grimace 0 to 2 (No/ Grimacing/ Screaming), Activity 0 to 2 (Flaccid/ Sluggish flexion movements/ Spontaneous good self-movement), Respiration 0 to 2 (None/ Slow, irregular breathing or gasping/ Regular (40/min)). Interpretation: normal: 9-10 points; marginal: 5-8 points; critical for the newborn: <5 points.
  measure: arterial umbilical cord pH
  time frame: within 4 weeks after birth
  description: Documented after labour and birth (medical birth record). Normal values in the umbilical artery blood are values of 7.20 - 7.38. At pH below 7.2 there is mild acidosis, below 7.1 moderate acidosis and below 7.0 severe acidosis.
  measure: Feasibility and effectiveness BreLax
  time frame: 13 weeks of pregnancy till 4 weeks after birth
  description: Self-reported by participants (digital diary and questionnaire). How often practiced before birth (text), how long practiced each time (Text) , where practiced (Text) , when used during birth (contractions irregular yes/no, contractions regular yes/no, at end of birth (pushing phase) yes/no, whole birth) yes/no.
  arm group label: Intervention group (BreLax)
  arm group type: Experimental
  description: BreLax: midwife-led antenatal education class
  arm group label: Control group (Standard care)
  arm group type: Active Comparator
  description: Midwife-led antenatal education class
  intervention type: Behavioral
  intervention name: BreLax: Antenatal education class
  description: An antenatal education class over 9 hours with information regarding pregnancy, labour and birth, pain management as well as the postpartum period with an integrated breathing and relaxation technique (prolonged exhalation in the individual rhythm) and 4 accompanying positions (standing upright, sitting supported, four-footed, supported lying on the side). In addition, participants receive a manual for independent practice at home.
  arm group label: Intervention group (BreLax)
  intervention type: Behavioral
  intervention name: Standard care (control)
  description: An antenatal education class over 9 hours, with information regarding pregnancy, labour and birth, pain management and the postpartum period as well as some relaxation exercises.
  arm group label: Control group (Standard care)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vanessa Leutenegger, RM, MScN
  phone: +41589344369
  email: vanessa.leutenegger@zhaw.ch
  facility: 
  contact: 
  investigator: 
  country: Switzerland
  citation: Shand AW, Lewis-Jones B, Nielsen T, Svensson J, Lainchbury A, Henry A, Nassar N. Birth outcomes by type of attendance at antenatal education: An observational study. Aust N Z J Obstet Gynaecol. 2022 Dec;62(6):859-867. doi: 10.1111/ajo.13541. Epub 2022 May 17.
  PMID: 35581951
  citation: Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Saisto T. Obstetric outcome after intervention for severe fear of childbirth in nulliparous women - randomised trial. BJOG. 2013 Jan;120(1):75-84. doi: 10.1111/1471-0528.12011. Epub 2012 Nov 2.
  PMID: 23121002
  citation: Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009 Apr;25(2):114-25. doi: 10.1016/j.midw.2006.12.012. Epub 2007 Apr 24.
  PMID: 17459542
  citation: Svensson J, Barclay L, Cooke M. Effective antenatal education: strategies recommended by expectant and new parents. J Perinat Educ. 2008 Fall;17(4):33-42. doi: 10.1624/105812408X364152.
  PMID: 19436529
  citation: Ip WY, Tang CS, Goggins WB. An educational intervention to improve women's ability to cope with childbirth. J Clin Nurs. 2009 Aug;18(15):2125-35. doi: 10.1111/j.1365-2702.2008.02720.x.
  PMID: 19583645
  citation: Ahlden I, Ahlehagen S, Dahlgren LO, Josefsson A. Parents' expectations about participating in antenatal parenthood education classes. J Perinat Educ. 2012 Winter;21(1):11-7. doi: 10.1891/1058-1243.21.1.11.
  PMID: 23277726
  citation: Schmidt G, Stoll K, Jager B, Gross MM. [German Version of the Childbirth Self-Efficacy Inventory and its Short Form]. Z Geburtshilfe Neonatol. 2016 Feb;220(1):28-34. doi: 10.1055/s-0035-1547296. Epub 2015 Sep 17. German.
  PMID: 26378776
  responsible party type: Principal Investigator
  investigator affiliation: Zurich University of Applied Sciences
  investigator full name: Vanessa Leutenegger
  investigator title: PhD Student
  mesh term: Respiratory Aspiration
  sharing ipd: No