<?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>IRCT20231111060019N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating  the effect of  game-based education  about  preterm infant care to mothers on their self-efficacy and happiness</public_title>
      <acronym></acronym>
      <scientific_title>Investigating  the effect of  game-based education  about  preterm infant care to mothers on their self-efficacy and happiness</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73691</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In order to prevent data contamination, first the data will be collected in the control group and after the discharge of the last baby in the control group, the intervention will begin.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Self-efficacy and happiness of mothers of premature babies.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, mothers meeting the entry criteria received game-based training during training sessions using playing cards (each session for 60 minutes), daily and in groups (choosing mothers to be placed in groups based on homogeneity It will be the day of their hospitalization.) According to the researcher's plan, they will receive and the games will continue daily until the baby is discharged. Game-based training (infection control, hand washing, breastfeeding training, newborn care such as how to bathe, change diapers, warning signs) includes training in three ways: playing cards, station review, and baby care information pool. And in order to teach care in the form of a game, a number of colored cards are used. For each care or educational point, 4 colored cards are prepared (first card: name of care, second card: definition of care, third card: benefits and fourth card: warnings). The game is used.During the first session, first, the method and method of playing the game along with the goals will be presented to the mothers by the researcher along with questions and answers. The implementation of the game in the first session will be based on the fact that first the mothers are divided into two groups, then in each group the mothers face each other. are placed and the cards (green card: name of care, red card: definition of care, red card: benefits and red card: warning) are randomly distributed among mothers so that each mother is given 4 cards. (1 green card and 3 red cards). The first mother, who starts the game, keeps the green card among the cards in her hand until the end of the game, and among the red cards, she keeps those related to the desired care and the unrelated card. Gives to the next mother. The next mothers do the same thing. This game and the rotation of cards between the mothers continues until one of the mothers announces that she has succeeded in completing her care puzzle.Then this mother is obliged to fully explain the care to other mothers, and if the researcher confirms the accuracy of the information, the mother will receive a gold card. Then this mother is out of the game and must be present with other mothers until the end of the game. And the other mothers continue to play until one of them declares that he has completed the care puzzle and the process of checking the accuracy of the contents and receiving the golden card is repeated.  The second session is when mothers participate in the station review session. A number of pink cards (which contain descriptive questions about care) are provided to mothers, and the mother chooses a card from among her cards and answers the question, if she answers correctly, she receives a golden card, and if Not knowing the correct answer, other mothers answer the question.In the third meeting, mothers participate in the information pool meeting. Mothers are randomly divided into two groups. In this program, all the cards that were taught on the first day are scattered on the table and the mothers of each group are asked to put the cards related to each care side by side within a period of 15 minutes. In order to increase competition and motivation, each group receives a golden card for the number of cares completed, and finally, in the next sessions, the games of the first to third sessions are repeated by the mothers. At the end of the games, the number of golden cards of the mothers is counted, and the first to third placers are awarded prizes of their choice (diapers, baby shampoo, baby creams and lotions, and other hygiene items needed by the baby, manual breast pump). Intervention 2: Control group: In the control group, the mothers receive ward routine training (ward rules, infection control, hand washing, breastfeeding training, newborn care) which is provided individually by the ward nurses in the form of lectures and presentation of educational pamphlets.</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:
All data is potentially shareable after de-identifying individuals.

When:
The access period starts 1 month after the results are published

To whom:
The data will be available to researchers working in academic and scientific institutions.

Conditions:
The data will be available to researchers working in academic and scientific institutions.

Where to obtain:
To the researcher by email
Principal investigator: Dr. Betul Pouraboli
b.pouraboli@gmail.com
 Masters student: Mona Habibi
mona.habibi1375@gmail.com

How to obtain:
The applicant can access the information by submitting valid application documents through the relevant scientific institution.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tawheed Square, Dr. Mirkhani St. (East Nusrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>mona.habibi1375@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mona Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tawheed Square, Dr. Mirkhani St. (East Nusrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>mona.habibi1375@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers of babies whose babies were born prematurely (34-37 weeks).
At least 4 days have passed since the baby was admitted
Absence of history of known psychiatric disorders under treatment in the mother, based on individual statements and documents in the file</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>In case of unwillingness to participate in the study at any stage of the research
A newborn suffering from a specific disease, including heart disorders or various syndromes
Mother's non-attendance for more than one session in training sessions using playing cards
Early discharge of the baby (earlier than 3 sessions of training using playing cards) from the neonatal intensive care unit</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other preterm infants</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, mothers meeting the entry criteria received game-based training during training sessions using playing cards (each session for 60 minutes), daily and in groups (choosing mothers to be placed in groups based on homogeneity It will be the day of their hospitalization.) According to the researcher's plan, they will receive and the games will continue daily until the baby is discharged. Game-based training (infection control, hand washing, breastfeeding training, newborn care such as how to bathe, change diapers, warning signs) includes training in three ways: playing cards, station review, and baby care information pool. And in order to teach care in the form of a game, a number of colored cards are used. For each care or educational point, 4 colored cards are prepared (first card: name of care, second card: definition of care, third card: benefits and fourth card: warnings). The game is used.During the first session, first, the method and method of playing the game along with the goals will be presented to the mothers by the researcher along with questions and answers. The implementation of the game in the first session will be based on the fact that first the mothers are divided into two groups, then in each group the mothers face each other. are placed and the cards (green card: name of care, red card: definition of care, red card: benefits and red card: warning) are randomly distributed among mothers so that each mother is given 4 cards. (1 green card and 3 red cards). The first mother, who starts the game, keeps the green card among the cards in her hand until the end of the game, and among the red cards, she keeps those related to the desired care and the unrelated card. Gives to the next mother. The next mothers do the same thing. This game and the rotation of cards between the mothers continues until one of the mothers announces that she has succeeded in completing her care puzzle.Then this mother is obliged to fully explain the care to other mothers, and if the researcher confirms the accuracy of the information, the mother will receive a gold card. Then this mother is out of the game and must be present with other mothers until the end of the game. And the other mothers continue to play until one of them declares that he has completed the care puzzle and the process of checking the accuracy of the contents and receiving the golden card is repeated.  The second session is when mothers participate in the station review session. A number of pink cards (which contain descriptive questions about care) are provided to mothers, and the mother chooses a card from among her cards and answers the question, if she answers correctly, she receives a golden card, and if Not knowing the correct answer, other mothers answer the question.In the third meeting, mothers participate in the information pool meeting. Mothers are randomly divided into two groups. In this program, all the cards that were taught on the first day are scattered on the table and the mothers of each group are asked to put the cards related to each care side by side within a period of 15 minutes. In order to increase competition and motivation, each group receives a golden card for the number of cares completed, and finally, in the next sessions, the games of the first to third sessions are repeated by the mothers. At the end of the games, the number of golden cards of the mothers is counted, and the first to third placers are awarded prizes of their choice (diapers, baby shampoo, baby creams and lotions, and other hygiene items needed by the baby, manual breast pump).</i_keyword>
      <i_keyword>Control group: In the control group, the mothers receive ward routine training (ward rules, infection control, hand washing, breastfeeding training, newborn care) which is provided individually by the ward nurses in the form of lectures and presentation of educational pamphlets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In this research, happiness means the score that the mother gets from the Oxford Happiness Questionnaire. This questionnaire has 29 items. The questions of the questionnaire are scored based on a four-point spectrum and measure the level of individual happiness. The theoretical basis of this questionnaire is Argyll and Crosland's definition of happiness; It is graded based on a four-point scale from 0 to 3. Thus, the highest score that the respondent can get in this scale is 87, which represents the highest level of happiness, and the lowest score of this scale is 0. Timepoint: The Oxford happiness questionnaire will be completed by the mothers of both control and intervention groups before the start of the first game session, and the same questionnaires will be completed in the control and intervention groups after the intervention (at discharge). Method of measurement: Oxford Happiness Questionnaire.</prim_outcome>
      <prim_outcome>In this research, self-efficacy means the score that the mother gets from the questionnaire of mothers' self-efficacy in motherhood. This questionnaire has 20 items and each item is based on a Likert scale from completely agree to completely disagree. This questionnaire has four areas including: caring processes, stimulating behaviors, understanding behaviors and situational beliefs. The range of points is between 20 and 80.The score is scored between 1 and 25 for low self-efficacy, 26 to 65 for medium self-efficacy, and 66 to 80 for high self-efficacy. Timepoint: The self-efficacy questionnaire of mothers in mothering will be completed by the mothers of both control and intervention groups before the start of the first game session, and the same questionnaires will be completed in the control and intervention groups after the intervention (at discharge). Method of measurement: Self-efficacy questionnaire of mothers in motherhood.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-07</approval_date>
        <contact_name>ًًResearch Ethics Committees of school  of Nursing and Midwifery and Rehabilitation - Tehran Univers</contact_name>
        <contact_address>Tawheed Square, Dr. Mirkhani St. (East Nusrat) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
