<?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>IRCT20230719058841N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of peer support through social networks on the stress and caring ability of mothers’ premature infants after discharge</public_title>
      <acronym></acronym>
      <scientific_title>The effect of peer support through social networks on the stress and caring ability of mothers’ premature infants after discharge</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71570</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling is available and allocation of mothers of premature babies to two groups of control and intervention is random and  by lottery with closed pocket.
The samples will be randomly divided into intervention and control groups. In order to randomly assign the participants to two groups, first 35 cards A (intervention group) and 35 cards B (control group) will be prepared. After shuffling the cards, the mothers are asked to take one card respectively, then the samples will be placed in one of the intervention or control groups based on the card taken. In this way, all participants will have an equal chance to be placed in two groups, Blinding description: Data analyzer don't know who is control or intervention group.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Premature infant.</hc_freetext>
      <i_freetext>Intervention group: Peer groups will start communicating with the mother before discharge and will be in contact with the mothers of premature babies in the group during one month through the Ita social network. Peers provide psychological and emotional support to newly discharged mothers and provide them with their experiences according to the questions raised in the group. Peers are asked to give intellectual and advisory help to mothers in taking care of the baby in the first month. Facilitating group discussion and providing correct scientific information and paying attention to the process of group dynamics and preventing the exchange of wrong information will be other duties of the researcher .Control group: mothers with premature babies receive routine care and can contact the department if they have any questions or problems. They complete the questionnaires before the baby's discharge and at the end of the first month after the discharge .The samples will be randomly divided into intervention and control groups. In order to randomly assign the participants to two groups, first 35 cards A (intervention group) and 35 cards B (control group) will be prepared. After shuffling the cards, the mothers are asked to take one card respectively, then the samples will be placed in one of the intervention or control groups based on the card taken. In this way, all participants will have an equal chance to be placed in two groups.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
At the end of the work and after printing the article, with permission from the Mashhad Nursing and Midwifery Faculty and the relevant professors, the information will be accessible in the central library of the Mashhad Nursing and Midwifery Faculty in the student thesis.

When:
Access starts 3 months after results are published

To whom:
Researchers working in academic institutions

Conditions:
Researchers with related fields can use the data and results by mentioning the reference.

Where to obtain:
Correspondence with project manager, Dr. Naghme Razaghi RazaghiN@mums.ac.ir Postal code: 91778-99191

How to obtain:
Apply by email
razaghiN@mums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Ebrahimnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Ebrahimnezhadm4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naghme Razaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebnecina street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>051338591511</telephone>
        <email>RazaghiN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature babies with a gestational age of less than 30 weeks
Premature babies with a birth weight of less than 1500 grams
Willingness to participate in the study
Mother's physical health
Having a smartphone
The ability to use a smartphone and virtual space (social networks)</inclusion_criteria>
      <agemin>14 days</agemin>
      <agemax>2 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any health-threatening congenital abnormalities
Mother's addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>060.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm spontaneous labour with preterm delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Peer groups will start communicating with the mother before discharge and will be in contact with the mothers of premature babies in the group during one month through the Ita social network. Peers provide psychological and emotional support to newly discharged mothers and provide them with their experiences according to the questions raised in the group. Peers are asked to give intellectual and advisory help to mothers in taking care of the baby in the first month. Facilitating group discussion and providing correct scientific information and paying attention to the process of group dynamics and preventing the exchange of wrong information will be other duties of the researcher .Control group: mothers with premature babies receive routine care and can contact the department if they have any questions or problems. They complete the questionnaires before the baby's discharge and at the end of the first month after the discharge .The samples will be randomly divided into intervention and control groups. In order to randomly assign the participants to two groups, first 35 cards A (intervention group) and 35 cards B (control group) will be prepared. After shuffling the cards, the mothers are asked to take one card respectively, then the samples will be placed in one of the intervention or control groups based on the card taken. In this way, all participants will have an equal chance to be placed in two groups</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The care ability of mothers of premature babies will be evaluated in the intervention and control groups. Timepoint: They will be evaluated before entering the group and one month after the intervention. Method of measurement: They are evaluated using the care capacity questionnaire.</prim_outcome>
      <prim_outcome>The stress of mothers of premature infant. Timepoint: It is checked before entering the group and( after intervention)  one month after the training. Method of measurement: They are evaluated using Cohen's 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-30</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Central building of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
