<?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>IRCT2015062922978N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effects of Discharge Planning on the Quality of Life of Mothers of Premature Infants</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of the Designed Discharge Planning on the Quality of Life Mothers Premature Infants&#13;
&#13;
The Effect of the Designed Discharge Planning on the Quality of Life Mothers Premature Infants&#13;
&#13;
The Effect of the Designed Discharge Planning on the Quality of Life Mothers Premature Infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19716</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of life of mothers of premature infants.</hc_freetext>
      <i_freetext>Intervention 1: for intervention groups of discharge planning for 4 Training sessions for mothers (30-45 minutes each session) based on premature infants discharged just two times a week in the break room mother and baby bed Through direct instruction and face-to-face The first 48 hours of their mother in NICU Held until discharch time. The first meeting of the features of premature infants and cause of infant hospitalization, The second session of maintaining body temperature and control it, the position of the baby, feed and method of feeding and medication to prevent infection, The third meeting of irritation Attention apnea, safe sleeping environment, Kangaroo Mother Careو Fourth session on the growth and development of infants, vaccination and necessity of screening for hearing, vision and ultrasound is. The visits premature infants during the first 48 hours will be at the bedside of their mother. And then the mother timing for the next turn and be given the necessary training. And the last meeting will be 2-1 days before discharge. After discharge the telephone counseling once a week for 4 weeks, in order to continued training and follow-up screening is carried out for a period of 5-10 minutes. Intervention 2: The control group received usual care in unit.</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>Soheila Karbandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery  Mashhad, Crossroads Doktora,  University Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 518591511</telephone>
        <email>karbandiS@mums.ac.ir NeyestaniA921@mums.ac.ir</email>
        <affiliation>Nursing and Midwifery, Mashhad Univercity</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Karbandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Crossroads Doktora, University Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>karbandiS@mums.ac.ir  NeyestaniA921@mums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery, Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for neonatal: Age 30-35 week; weight of 1200 grams; fifth minute Apgar scores of 7 or more; lack of need for mechanical ventilation; no obvious abnormalities and genetic disorders (disorders gastrointestinal, cardiovascular, urinary, reproductive, nervous and trisomy 13,18,21); singletons. &#13;
 mothers inclusion criteria: age 18-35 years; no smoking and tobacco; lack of experience severe stress event 6 months; no history of mental illness; depression and chronic anxiety (according to the mother); Iranian; having the ability to speak Farsi; at least primary education; phone; having to live with his wife and her husband's only wife; In the field of medical science is uneducated; mother does not have a medical problem (heart problems, kidney disease, epilepsy, neurological); lack of disability or debilitating disease in family members; Informed consent to complete; Lack of losing a parent before the age of elevent; demands of pregnancy; Consent of sex; The mother of the baby's bedside&#13;
 Exclusion criteria during the study: to be hospitalized for over a mon and less than a week; incurable disease risk; newborn baby feet; Maternal disease to medical or psychiatric conditions (depression  delivery, breathing problems, kidney, cardiovascular, infectious, neurological); Get the Edinburgh postpartum depression score 13 orand the visit time of discharge and 4 weeks after discharge; anxiety-causing event during the intervention( death of close relatives, spiritual crises, financial crises and divorce); the incidence of disability or debilitating disease in family members (spouse, son)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders related to short gestation and low birth weight, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>for intervention groups of discharge planning for 4 Training sessions for mothers (30-45 minutes each session) based on premature infants discharged just two times a week in the break room mother and baby bed Through direct instruction and face-to-face The first 48 hours of their mother in NICU Held until discharch time. The first meeting of the features of premature infants and cause of infant hospitalization, The second session of maintaining body temperature and control it, the position of the baby, feed and method of feeding and medication to prevent infection, The third meeting of irritation Attention apnea, safe sleeping environment, Kangaroo Mother Careو Fourth session on the growth and development of infants, vaccination and necessity of screening for hearing, vision and ultrasound is. The visits premature infants during the first 48 hours will be at the bedside of their mother. And then the mother timing for the next turn and be given the necessary training. And the last meeting will be 2-1 days before discharge. After discharge the telephone counseling once a week for 4 weeks, in order to continued training and follow-up screening is carried out for a period of 5-10 minutes.</i_keyword>
      <i_keyword>The control group received usual care in unit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Qoality of life. Timepoint: Before the intervention, discharge, four weeks after discharge. Method of measurement: WHOQOL BREF.</prim_outcome>
      <prim_outcome>Social support. Timepoint: Before the intervention, discharge and 4 weeks after discharge. Method of measurement: Multidimensional scale of pereceived social support.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Marital Satisfaction. Timepoint: befor intervention. Method of measurement: Four ENRICH Couple Scales.</sec_outcome>
      <sec_outcome>Postpartum Depression. Timepoint: Before intervention, discharge and 4 weeks after discharge. Method of measurement: Edinburgh Postnatal Depression Scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-15</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>University Of Vice President of Research, University Avenue, Doktora Crossroads Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
