<?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>IRCT20111207008315N29</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-27</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect  of hand hygiene education on knowledge and practice of mothers</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of education by face to face and through watching film on hand ‎hygiene knowledge and performance of mothers in neonatal intensive care unit: ‏a ‎clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>132</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31972</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random pattern and allocation to groups will be done by computer using a randomized complete block with size 3. Random sequence that will be generated by software RAS. Mother will be assigned randomly  to one of the groups (film, face to face and control). The groups obtained from this type of randomization are placed inside separate envelopes. Envelopes are sequentially numbered. The first qualified mother chooses the envelope number one and the second mother, number two and so on.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Education.</hc_freetext>
      <i_freetext>Intervention 1: In the film group, mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.  Mothers then watch the video tutorial on how to wash hands in accordance with the approved WHO guideline  through the personal computer monitor of the researcher individually in the mothers' room. On the third day, once again, each mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher. Intervention 2: In the face  to face group, mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.  The mothers then receive a WHO approved  training on how to wash hands for 4 minutes by nurse through  face-to-face. On the third day, once again, each mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher. Intervention 3: In the Control group, mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher. The mothers in the control group did not receive any intervention and behaved as routine. . On the third day, once again, each mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.</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>Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 9785</telephone>
        <email>valizadehl@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 9785</telephone>
        <email>valizadehl@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother’s willingness to participate in the study
Mothers ‎with newborns who hospitalized in  neonatal intensive care unit (NICU) ‎and mothers participate in her baby's care.
Have at least  the ability to read and write
The first day of hospitalization, the baby and the mother is in the hospital.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a wound or an obstacle to hand washing
Mother is a health system worker
Mother has been trained to wash her hands</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z76.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for health supervision and care of other healthy infant and child</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the film group, mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.  Mothers then watch the video tutorial on how to wash hands in accordance with the approved WHO guideline  through the personal computer monitor of the researcher individually in the mothers' room. On the third day, once again, each mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.</i_keyword>
      <i_keyword>In the face  to face group, mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.  The mothers then receive a WHO approved  training on how to wash hands for 4 minutes by nurse through  face-to-face. On the third day, once again, each mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.</i_keyword>
      <i_keyword>In the Control group, mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher. The mothers in the control group did not receive any intervention and behaved as routine. . On the third day, once again, each mothers will complete self- administered questionnaire about knowledge on the importance of hand hygiene , and individually wash their hands before entering the department and the WHO hand washing checklist will be completed through observation by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hand hygiene Knowledge  score by face to face education and through watching film. Timepoint: Before the intervention and the third day after the intervention. Method of measurement: Awareness Questionnaire.</prim_outcome>
      <prim_outcome>Hand hygiene Performance  score by face to face education and through watching film. Timepoint: Before the intervention and the third day after the intervention. Method of measurement: Hand washing check list.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-25</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
