<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2015062722939N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-31</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan university of medical science</primary_sponsor>
      <public_title>The impact of education on the fatigue and sleep disorders in the mother and infant in the postpartum period</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of face to face training and E-learning on the fatigue and maternal and  baby’s  quality of sleep in the postpartum period</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19678</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: For randomization, among all cases in health centers, 10 cases of postpartum mothers on the basis of inclusion criteria will be selected randomly. Random selection of cases will be on the basis of weekdays. Meaning that Saturday and Tuesday will be assigned to face-to-face training group, Sunday and Wednesday will be assigned to E-learning group, Monday and Thursday will be dedicated to the control group. Then every day, with convenient sampling method, qualified individuals are selected for inclusion.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatigue and sleep disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Face to face training on the tenth day after birth for 45-30 minutes and then send the hygienic SMS until the sixtieth day after birth. Intervention 2: Intervention group 2: Giving an educational CD on the tenth day after birth and then sending the hygienic SMSs until the sixtieth day after birth. Intervention 3: Control group: No intervention &#13;
Just fill out the questionnaire.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 23, Twentieth alley, Hashemi nejad Street, Godal cheshmeh, Shahrekord.</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815775369</zip>
        <telephone>+98 38 3333 2602</telephone>
        <email>zahra.gholami@nm.mui.ac.ir; z.gholami309@gmail.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zahra gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 23, Twentieth alley, Hashemi nejad Street, Godal cheshmeh, Shahrekord.</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 38 3333 2602</telephone>
        <email>z.gholami309@gmail.com; zahra.gholami@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: People giving birth to live, singleton healthy, people who are breastfeeding (exclusive breastfeeding or with milk), No risk of bleeding during and after delivery (with the question of the mother), After delivery of the highest hospitalization was 3 days, having an underlying medical condition (asthma, kidney disease, congestive heart failure, gastroesophageal reflux disease, rheumatic disorders, joint pain and other musculoskeletal, diabetes) who are sleep disorders, Lack of depression during the study period (with the use of the Edinburgh Postnatal Depression Scale short-be determined (according to the Edinburgh questionnaire, people who score less than 13 get-out, depressed and those with scores equal to or greater than 13 acquire, they will be considered depressed), Married Women and Iranian nationality, no drug addiction and no Hypnotic drugs addiction (for example benzodiazepines), no repeated spontaneous abortions, no neonatal death, Non-working mother";"  Exclusion criteria: Unwillingness to continue cooperation during the study, not completing the questionnaire completely and correctly, people who suffer from postpartum depression during the study (diagnosed with the information given to mothers at the beginning of the study), providing any disease or disorder that it effects on the sleep of the mother and infant during the study such as long-term cold (more than three days), infectious diseases that cause fever, prolonged fever, hospitalization of the mother and infant, factors such as postpartum bleeding after the sampling.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other mental and behavioural disorders associated with the puerperium, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Face to face training on the tenth day after birth for 45-30 minutes and then send the hygienic SMS until the sixtieth day after birth</i_keyword>
      <i_keyword>Intervention group 2: Giving an educational CD on the tenth day after birth and then sending the hygienic SMSs until the sixtieth day after birth.</i_keyword>
      <i_keyword>Control group: No intervention &#13;
Just fill out the questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The mother fatigue. Timepoint: Before and one and two months after the intervention. Method of measurement: Intensity of fatigue Questionnaire.</prim_outcome>
      <prim_outcome>The sleep quality of the mother. Timepoint: Before and one and two months after the intervention. Method of measurement: The Pittsburgh Sleep Quality questionnaire.</prim_outcome>
      <prim_outcome>The sleep quality of infant. Timepoint: Before and one and two months after the intervention. Method of measurement: The record form of mean duration of infant’s sleep.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-----. Timepoint: ------. Method of measurement: -----.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>---</sec_id>
        <issuing_authority>---</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Isfahan university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-07</approval_date>
        <contact_name>Ethics comitte of  Isfahan university of Medical Sciences</contact_name>
        <contact_address>Hezar jarib street, Isfahan university of medical science,  Isfahan. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
