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/NCT05993936</url>
    </required_header>
    <id_info>
      <org_study_id>129</org_study_id>
      <nct_id>NCT05993936</nct_id>
    </id_info>
    <brief_title>THE EFFECT OF E-MOBILE TRAINING GIVEN POSTNATAL PERIOD ON POSTNATAL The Effect Of E-Mobıle Traınıng Gıven Postnatal Perıod On Postnatal Comfort And Breastfeedıng Self-Effıcıency</brief_title>
    <official_title>The Effect Of E-Mobıle Traınıng Gıven In The Postnatal Perıod On Postnatal Comfort And Breastfeedıng Self-Effıcıency</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cukurova University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cukurova 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 period until the 42nd day after birth is called the postpartum period by the World Health&#xD;
        Organization (WHO) Especially the first week of the postpartum period is the transition&#xD;
        period both physiologically and psychologically, and the period when postpartum problems are&#xD;
        at the highest level.This study was planned as a two-group control and e-mobile application&#xD;
        in order to determine the effect of e-mobile training given in the postpartum period on&#xD;
        postpartum comfort and breastfeeding self-efficacy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>mobile application aim 1</measure>
      <time_frame>postpartum 7th week</time_frame>
      <description>Thanks to the mobile application, it is planned to develop women's breastfeeding self-efficacy. As the scale score increases, self-efficacy changes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mobile application aim 2</measure>
      <time_frame>postpartum 7th week]</time_frame>
      <description>Thanks to the mobile application, it is expected that the postpartum comfort of women will changes. As the score obtained from the scale increases, the comfort changes</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Breastfeeding</condition>
    <arm_group>
      <arm_group_label>e mobile aplication</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Postpartum period mobile application; It is an application that is prepared according to the Android Operating System, can be downloaded free of charge from the Google Play Store, and offers training and live counseling services for women who have given birth.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>this group will only receive the standard care provided in the hospital. no intervention will be made</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>mobile application</intervention_name>
      <description>A mobile application developed by researchers for the problems experienced in the postpartum period and downloaded from the play store.</description>
      <arm_group_label>e mobile aplication</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The ages of 18-35, Primiparous and multiparous pregnancy, Not clinical diagnosis of risky&#xD;
          pregnancy, Able to understand and speak Turkish, Without communication difficulties and&#xD;
          mental disabilities The mother and the baby have not developed any complications during&#xD;
          pregnancy, delivery and postpartum period, Having a smart phone in the mobile application&#xD;
          group, Those who have not attended childbirth preparation classes,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Preterm birth&#xD;
  &#xD;
            -  Postterm birth&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cukurova University</investigator_affiliation>
      <investigator_full_name>seda karaçay yıkar</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <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/NCT05993936
  org study id: 129
  nct id: NCT05993936
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The period until the 42nd day after birth is called the postpartum period by the World Health
        Organization (WHO) Especially the first week of the postpartum period is the transition
        period both physiologically and psychologically, and the period when postpartum problems are
        at the highest level.This study was planned as a two-group control and e-mobile application
        in order to determine the effect of e-mobile training given in the postpartum period on
        postpartum comfort and breastfeeding self-efficacy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: mobile application aim 1
  time frame: postpartum 7th week
  description: Thanks to the mobile application, it is planned to develop women's breastfeeding self-efficacy. As the scale score increases, self-efficacy changes
  measure: mobile application aim 2
  time frame: postpartum 7th week]
  description: Thanks to the mobile application, it is expected that the postpartum comfort of women will changes. As the score obtained from the scale increases, the comfort changes
  arm group label: e mobile aplication
  arm group type: Experimental
  description: Postpartum period mobile application; It is an application that is prepared according to the Android Operating System, can be downloaded free of charge from the Google Play Store, and offers training and live counseling services for women who have given birth.
  arm group label: control
  arm group type: No Intervention
  description: this group will only receive the standard care provided in the hospital. no intervention will be made
  intervention type: Device
  intervention name: mobile application
  description: A mobile application developed by researchers for the problems experienced in the postpartum period and downloaded from the play store.
  arm group label: e mobile aplication
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cukurova University
  investigator full name: seda karaçay yıkar
  investigator title: Assistant professor
  sharing ipd: No