<?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>IRCT20240327061370N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-18</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the implementation developmental supportive care program on the resilience and mental health of mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the continued implementation of developmental supportive care program by mothers with premature infants on the level of resilience and mental health of mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79321</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The block randomization method will be used. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to. In this study, eligible male participants, after receiving informed consent, according to the block randomization protocol (produced by Random Allocation Software) were assigned to one of the two control and intervention groups with a ratio of 1:1 and in blocks of 6. will be given, in such a way that the researcher cannot predict in which intervention group the next person will be placed. The codes will be placed in the opaque envelopes, and with the entry of each new person, the envelope will be opened and the person's belonging to the relevant group will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Developmental Supportive Care. Resilience of mothers. Mental health of mothers..</hc_freetext>
      <i_freetext>Intervention group: After receiving the code of ethics, the protocol will be registered in the IRCT system and then sampling will begin. Informed consent will be obtained from the mother before the intervention. A pre-test will be taken to determine the state of resilience and mental health of mothers before the intervention during the first meeting of the mother with the infant in the unit. Then, the intervention group, during 5 sessions on 5 consecutive days, the supportive/developmental care program, one week before the possible date of discharge of their infant, every day and between the time period of 8 am to 8 pm and in one of the rooms of the neonatal special care department of Rouhani hospital. They will receive an individual form. Although the content of the day the mother was absent will be taught on the next day. During the intervention, the post-test for the intervention group will be completed by mothers at discharge and one month after discharge. It should be noted that the educational content of developmental supportive care will be presented face-to-face in 5 sessions for 30-45 minutes in the form of educational slides individually in one of the rooms of the neonatal intensive care unit of Rouhani Hospital. An educational video that includes (kangaroo mother care-how to breastfeed-changing diapers-bathing-moving and positioning) with a short duration (maximum 15 minutes) when mothers are in the ward (at least one week before the possible date of discharge) individually will be displayed. The pamphlet and educational content will be placed in the form of a text, audio and video file on the Iranian virtual messaging channel (ITA) so that mothers can use it in case of absence and lack of proper understanding of the concepts. In the current study, the researcher will give this opportunity to the mothers by forming virtual groups, so that the mothers can communicate with each other and with the researcher in a group and individually, and continuous follow-up in the form of a phone call every other day and if needed daily and It will even be done face-to-face with the mothers, and the necessary follow-ups and care will be pointed out to the mothers, so that the mother can fully participate in the care and participation of her infant. The intervention includes: Partnering with Families, Optimizing Nutrition management, Safeguarding Sleep, Protecting Skin care, Positioning &amp; Handling will be provided to mothers. Therefore, the mothers of the intervention group will be able to communicate with their peers (peer group) as well as with the researcher, in addition to phone calls, by sending text messages and on the messaging channel(ITA) with easy access and regardless of age, race and place of residence. Communicate with each other to emphasize and remind and review the contents.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsane Arzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganj Afrouz Avn., Babol, Mazandaran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۴۵</zip>
        <telephone>+98 11 3219 0557</telephone>
        <email>a.arzani@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Babol University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganj Afrouz Avn., Babol, Mazandaran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۴۵</zip>
        <telephone>+98 11 3219 0557</telephone>
        <email>a.arzani@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother with premature infants hospitalized in the neonatal intensive care unit with a fetal age of 28 to 34 weeks
Minimum hospitalization for 7 days
Literate mother
Being of Iranian origin
No history of hospitalization of previous children in the neonatal intensive care unit
No history of taking neuropsychiatric drugs or drug use by the mother</inclusion_criteria>
      <agemin>198 days</agemin>
      <agemax>238 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Death of neonate
Sending the neonate to other centers for further treatment
Mother's unwillingness to continue participating in the study
Absence of more than 2 sessions of mothers during 5 days of educational intervention
Mothers who are absent for more than one measurement time other than the initial time in the study process</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After receiving the code of ethics, the protocol will be registered in the IRCT system and then sampling will begin. Informed consent will be obtained from the mother before the intervention. A pre-test will be taken to determine the state of resilience and mental health of mothers before the intervention during the first meeting of the mother with the infant in the unit. Then, the intervention group, during 5 sessions on 5 consecutive days, the supportive/developmental care program, one week before the possible date of discharge of their infant, every day and between the time period of 8 am to 8 pm and in one of the rooms of the neonatal special care department of Rouhani hospital. They will receive an individual form. Although the content of the day the mother was absent will be taught on the next day. During the intervention, the post-test for the intervention group will be completed by mothers at discharge and one month after discharge. It should be noted that the educational content of developmental supportive care will be presented face-to-face in 5 sessions for 30-45 minutes in the form of educational slides individually in one of the rooms of the neonatal intensive care unit of Rouhani Hospital. An educational video that includes (kangaroo mother care-how to breastfeed-changing diapers-bathing-moving and positioning) with a short duration (maximum 15 minutes) when mothers are in the ward (at least one week before the possible date of discharge) individually will be displayed. The pamphlet and educational content will be placed in the form of a text, audio and video file on the Iranian virtual messaging channel (ITA) so that mothers can use it in case of absence and lack of proper understanding of the concepts. In the current study, the researcher will give this opportunity to the mothers by forming virtual groups, so that the mothers can communicate with each other and with the researcher in a group and individually, and continuous follow-up in the form of a phone call every other day and if needed daily and It will even be done face-to-face with the mothers, and the necessary follow-ups and care will be pointed out to the mothers, so that the mother can fully participate in the care and participation of her infant. The intervention includes: Partnering with Families, Optimizing Nutrition management, Safeguarding Sleep, Protecting Skin care, Positioning &amp; Handling will be provided to mothers. Therefore, the mothers of the intervention group will be able to communicate with their peers (peer group) as well as with the researcher, in addition to phone calls, by sending text messages and on the messaging channel(ITA) with easy access and regardless of age, race and place of residence. Communicate with each other to emphasize and remind and review the contents</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience of mothers. Timepoint: first meeting with the infant During discharge and one month after discharge. Method of measurement: Connor and Davidson Resilience Questionnaire.</prim_outcome>
      <prim_outcome>Mental health of mothers. Timepoint: first meeting with the infant During discharge and one month after discharge. Method of measurement: Goldberg General Health 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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-02</approval_date>
        <contact_name>Research ethics committee of health research institute - Babol University of Medical Sciences</contact_name>
        <contact_address>Ganj Afrouz Avn., Babol, Mazandaran babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
