<?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>IRCT20181112041628N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Tele Nursing Training on the Mental Status of Mothers of Patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of family-centered education on tele-nursing method on emotional reactions of mothers after bone marrow transplantation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35205</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples were randomly  waxed envelope in 33 individuals in the control group and 33 in the intervention group, Blinding description: After discharge, mothers will be randomly assigned to two groups of intervention and control. The control group and the intervention group will receive the training according to the routine section after the discharge, individually, and will contact the department in case of difficulty and the intervention group, in addition to the training, Individuals will receive tele nursing training  in the Watts app and their problems will be reviewed and organized.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bone marrow  transplantation.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group consisted of 33 mothers after discharge who were routinely trained in routine and individual care, as well as intermittently via Watts-up software for 40 days.  routine and individual education package includes  health, nutrition, treatment  follow-up, and question and answer. Intervention 2: Control group: The control group consisted of 33 nurses who received post-discharge education in a routine, individual and one-time delivery.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Sahebzamane</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sixth floor,Central Islamic Azad University Building.Boulevard Hesarak,Sattary Highway, University square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4735 1601</telephone>
        <email>m_szamani@iautmn.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Sahebzamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sixth floor,Central building Azad University ,boulevard Hesarak,University Square,Sattary highway ,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>m_szamani@iautmu.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Mothers aged between 20 and 45 2. Have complete satisfaction to participate in research 3- Have reading and writing skills 4. No psychiatric disorders and psychotropic drugs in the onset of research 5- No learning problems and diseases that directly affect Learning has an impact. 6. Having a smartphone and the ability to connect to the Internet and know how to use it</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Child's death during the research 2. Failure to connect to the Internet and lack of mother participation in the training process for one month or more 3- The mother's disease to mental problems and the need for psychedelic pills during the study period 4-Unwilling to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F30-F39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mood disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group consisted of 33 mothers after discharge who were routinely trained in routine and individual care, as well as intermittently via Watts-up software for 40 days.  routine and individual education package includes  health, nutrition, treatment  follow-up, and question and answer.</i_keyword>
      <i_keyword>Control group: The control group consisted of 33 nurses who received post-discharge education in a routine, individual and one-time delivery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional reactions (depression, stress and anxiety). Timepoint: 40 day. Method of measurement: DAS questionnaire.</prim_outcome>
      <prim_outcome>Emotional responses of mothers are measured after discharge. Timepoint: The next 40 days are measured again. Method of measurement: Depression and Anxiety Stress Measurement Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress. Timepoint: Before the intervention and 40 days after the intervention in the intervention group and in the control group, 40 days after the first and second. Method of measurement: depression anxiety Stress scale  questionnaire.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before the intervention and 40 days after the intervention in the intervention group and in the control group, 40 days after the first and second. Method of measurement: depression anxiety Stress scale  questionnaire.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: Before the intervention and 40 days after the intervention in the intervention group and in the control group, 40 days after the first and second. Method of measurement: depression anxiety Stress scale  questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-06</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Tehran University of Medical Sciences, Zargande street, Danesh  alley Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
