<?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>IRCT20200908048666N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-23</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of  spouse supportive program on stress and coping Strategy of mothers with premature infant in the selected hospital of  Isfahan University of Medical Sciences,</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of  spouse supportive program on stress and coping Strategy of mothers with premature infant in the selected hospital of  Isfahan University of Medical Sciences,</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50938</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Mothers of selected infants who meet the inclusion criteria are randomly divided into control and test groups. To randomize the samples, the number of paper card samples with the letter A (as the test word cipher) and the letter B (as the control cipher) written on the box will be placed in a box (half Cards have the letter A and the other half have the letter B) and mothers are asked to choose a card at random. Then mothers with an A card are in the experimental group and mothers with a B card are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress and coping strategies of mothers with premature infants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Demographic profile form, PSS-NICU questionnaire and SCQ questionnaire are completed by all units (mothers). The spouses of the intervention group also fill in the consent form, after which the researcher invites the spouses of the experimental group to participate in the training sessions. The training sessions include 3 one-hour sessions (Karami, Rostami, Ghadirian, 2009 and Hassani Taybi, Kermanshahi, 2013) and will be held in three days, from 13:00 to 14:00, in three days, after selecting the samples, in coordination with the spouses of the research units.Necessary arrangements will be made for the spouses to attend the first visit (at the time of sample selection) and the schedule for the spouses' presence in the hospital will be delivered to them in the form of a tract. The content of the sessions was compiled according to the studies and the principles of NeedCap (Valizadeh, Akbar Begloo, Asadollahi 2009 and Karami, Rostami, Ghadirian, 2009 and Hassani Taybi, Kermanshahi, 2013) and was approved by 10 faculty members.Scheduled training sessions with lectures, questions and answers, role-playing and practical work in the form of group training and face-to-face using PowerPoint, videos, pictures, dolls for spouses by the researcher and in the presence of a psychiatric nurse at the training classes Shahid Beheshti Educational and Medical Center will be held. The content of the educational package includes: Session 1: Explaining the objectives of the study, the benefits of using the educational content, presenting the educational package of baby care using the principles of NeedCup, including: teaching kangaroo care, establishing a suitable position for the baby, controlling pain by non-pharmacological methods, changing clothes and diapers Baby, baby skin care. Also, providing a maternal care training package, including: personal health education, skin and wound care, maternal nutrition and proper breastfeeding. Session 2: Providing training and solutions on emotional support and self-confidence by the researcher in the presence of a colleague Psychiatric nurse.At the end of the sessions, the spouses will be explained that for the next 5 days (5 days after the end of the training classes) once a day (Ghaderi et al., 2013) for one hour (in coordination with the head of the ward) at the time of the hospital visit Find and support mothers using the educational content provided, and then on the fifth day (after one hour of meeting and support of spouses) the researcher will again provide the PSS-NICU questionnaire and the SCQ questionnaire to the mothers of the control group and the experimental group to complete. Intervention 2: Control group: The control group will receive the support and routine training of the hospital, and after the intervention, each of the mothers in the control group will receive a pamphlet prepared from the educational materials presented in the training sessions for themselves and their spouses to study.</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 Maintaining confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedigheh Talakoob</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, Complex Samen 4, West Sheikh Safi St, Lahore St.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8156756881</zip>
        <telephone>+98 31 3250 5923</telephone>
        <email>jalali.maryam7580@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh Talakoob</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, Complex Samen 4, West Sheikh Safi St, Lahore St.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8156756881</zip>
        <telephone>+98 31 3250 5923</telephone>
        <email>jalali.maryam7580@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Parents are interested in participating in the study
2- Be able to speak, read and write in Persian
3- Have not previously participated in sessions on training in infant and mother care and maternal support (any other research project in this field)
4- According to the information recorded in the infants' file, mothers should not have any mental illness or drug addiction and should not take any psychiatric medication
5. Mothers in the last 12 months have not experienced severe stress including: death of spouse, divorce, life apart from spouse, imprisonment, death of a family member and illness (Holmes, Rahe, 1967) which will be determined by asking mothers
6- Parents do not have a previous history of hospitalizing the baby in the neonatal intensive care unit</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- Existence of any problem so that parents are not able to continue participating in the study
2. Spouses should be absent from more than one training session
3- Mothers after childbirth suffer from postpartum complications such as thrombophlebitis, postpartum infection, pulmonary embolism, severe bleeding
4- The baby's condition deteriorates or dies
5- Separation or death of the spouse occurs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Demographic profile form, PSS-NICU questionnaire and SCQ questionnaire are completed by all units (mothers). The spouses of the intervention group also fill in the consent form, after which the researcher invites the spouses of the experimental group to participate in the training sessions. The training sessions include 3 one-hour sessions (Karami, Rostami, Ghadirian, 2009 and Hassani Taybi, Kermanshahi, 2013) and will be held in three days, from 13:00 to 14:00, in three days, after selecting the samples, in coordination with the spouses of the research units.Necessary arrangements will be made for the spouses to attend the first visit (at the time of sample selection) and the schedule for the spouses' presence in the hospital will be delivered to them in the form of a tract. The content of the sessions was compiled according to the studies and the principles of NeedCap (Valizadeh, Akbar Begloo, Asadollahi 2009 and Karami, Rostami, Ghadirian, 2009 and Hassani Taybi, Kermanshahi, 2013) and was approved by 10 faculty members.Scheduled training sessions with lectures, questions and answers, role-playing and practical work in the form of group training and face-to-face using PowerPoint, videos, pictures, dolls for spouses by the researcher and in the presence of a psychiatric nurse at the training classes Shahid Beheshti Educational and Medical Center will be held. The content of the educational package includes: Session 1: Explaining the objectives of the study, the benefits of using the educational content, presenting the educational package of baby care using the principles of NeedCup, including: teaching kangaroo care, establishing a suitable position for the baby, controlling pain by non-pharmacological methods, changing clothes and diapers Baby, baby skin care. Also, providing a maternal care training package, including: personal health education, skin and wound care, maternal nutrition and proper breastfeeding. Session 2: Providing training and solutions on emotional support and self-confidence by the researcher in the presence of a colleague Psychiatric nurse.At the end of the sessions, the spouses will be explained that for the next 5 days (5 days after the end of the training classes) once a day (Ghaderi et al., 2013) for one hour (in coordination with the head of the ward) at the time of the hospital visit Find and support mothers using the educational content provided, and then on the fifth day (after one hour of meeting and support of spouses) the researcher will again provide the PSS-NICU questionnaire and the SCQ questionnaire to the mothers of the control group and the experimental group to complete.</i_keyword>
      <i_keyword>Control group: The control group will receive the support and routine training of the hospital, and after the intervention, each of the mothers in the control group will receive a pamphlet prepared from the educational materials presented in the training sessions for themselves and their spouses to study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress and coping strategies using the stress questionnaire of parents of infants admitted to the neonatal intensive care unit and Lazarus and Folkman coping strategies questionnaire. Timepoint: Stress measurement and coping strategies before the intervention and then 5 days after the end of the training sessions. Method of measurement: questionnaire of parents of infants admitted to the neonatal intensive care unit and Lazarus and Folkman coping strategies questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-14</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Feiz hospital,  Modarres Str, Qds Ave Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
