<?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>IRCT201204078315N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-02</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Simulation on Placement Peripheral Intravenous Line in Pediatric</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Simulation and Demonstration Training on Baccalaureate nursing Student's Skill and Self Confidence Related to Placement Peripheral Intravenous Line in Pediatric</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8762</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Inadequate teaching.</hc_freetext>
      <i_freetext>Intervention 1: The second intervention group includes students that is being trained with demonstration method. At first the researcher describes the purpose of this procedure and the necessary instrument to them. Then the researcher demonstrates this procedure on infant manikin in skill laboratory for 15 minutes. Then each student tries to do this procedure on infant manikin for 15 minutes. The time for training &amp; practice is limited to 30 minutes. Intervention 2: The first intervention group includes students that will be trained placement  Peripheral Intravenous Line in pediatric in skill laboratory of nursing and midwifery faculty for 45 minutes. For the simulation training, members of the experimental group signed up to come to the learning laboratory in pairs. Prior to the start of the simulation, subjects were oriented to the learning objectives, equipment, setting, student and facilitator roles, and expectations for the simulation. All simulation participants will be provided with a written scenario for the simulation. One subject will be randomly selected to act as the nurse that should place Peripheral Intravenous Line on an infant manikin in the skill laboratory for 15 minutes and interact with child family and the other subject will be in the role of an observer. Researcher acts as a facilitator and child’s mother. During the simulation, the observer and Researcher will take note of the nurse’s performance related to both the placement Peripheral Intravenous Line in pediatric skill as well as interpersonal relations. After the completion of the first simulation, the subject pair will switch roles and completed a second simulation using a different scenario. Immediately after completion of both simulations, the subject pair and facilitator will conduct a 15-minute debriefing session. The Researcher will facilitate the debriefing discussion. During the debriefing, subjects will discuss personal feelings about the simulation and their skill related to placement Peripheral Intravenous Line in pediatric as well as will provide objective feedback to the other subject on his/her performance. The Researcher also will add additional feedback and answer to the subject’s questions or concerns. The time for training &amp; practice is limited to 45 minutes. Intervention 3: There is no intervention for participants in control group and they only receive routine training by lecturing and showing slides.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariety South St; Faculty of Nursing &amp; Midwifery ; Tabriz ; Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 914 412 5864</telephone>
        <email>valizadehl@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariety South St ; Faculty of Nursing &amp; Midwifery of Tabriz ; Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 4114796770152</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>Inclusion criteria: Willingness to participate in the study; 5 and 6 semesters of undergraduate nursing students; No previous experience with Placement Peripheral Intravenous Line in Pediatric Exclusion criteria: Guest  or transferstudent from two and three type of medical sciences university;  having Detectable disease affecting learning ; Not participate in training sessions or periodic tests; Risk of stress or adverse conditions in the training and test sessions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z55.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other problems related to education and literacy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The second intervention group includes students that is being trained with demonstration method. At first the researcher describes the purpose of this procedure and the necessary instrument to them. Then the researcher demonstrates this procedure on infant manikin in skill laboratory for 15 minutes. Then each student tries to do this procedure on infant manikin for 15 minutes. The time for training &amp; practice is limited to 30 minutes.</i_keyword>
      <i_keyword>The first intervention group includes students that will be trained placement  Peripheral Intravenous Line in pediatric in skill laboratory of nursing and midwifery faculty for 45 minutes. For the simulation training, members of the experimental group signed up to come to the learning laboratory in pairs. Prior to the start of the simulation, subjects were oriented to the learning objectives, equipment, setting, student and facilitator roles, and expectations for the simulation. All simulation participants will be provided with a written scenario for the simulation. One subject will be randomly selected to act as the nurse that should place Peripheral Intravenous Line on an infant manikin in the skill laboratory for 15 minutes and interact with child family and the other subject will be in the role of an observer. Researcher acts as a facilitator and child’s mother. During the simulation, the observer and Researcher will take note of the nurse’s performance related to both the placement Peripheral Intravenous Line in pediatric skill as well as interpersonal relations. After the completion of the first simulation, the subject pair will switch roles and completed a second simulation using a different scenario. Immediately after completion of both simulations, the subject pair and facilitator will conduct a 15-minute debriefing session. The Researcher will facilitate the debriefing discussion. During the debriefing, subjects will discuss personal feelings about the simulation and their skill related to placement Peripheral Intravenous Line in pediatric as well as will provide objective feedback to the other subject on his/her performance. The Researcher also will add additional feedback and answer to the subject’s questions or concerns. The time for training &amp; practice is limited to 45 minutes.</i_keyword>
      <i_keyword>There is no intervention for participants in control group and they only receive routine training by lecturing and showing slides.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Baccalaureate nursing Students' Self Confidence Related to Placement Peripheral Intravenous Line in Pediatric. Timepoint: Once before the intervention and Once again, two weeks after the interventiont. Method of measurement: Based on a scale to measure self-confidence when performing psychomotor skills.</prim_outcome>
      <prim_outcome>Baccalaureate nursing Students' Skill Related to Placement Peripheral Intravenous Line in Pediatric. Timepoint: Once before the intervention and again 2 weeks after intervention. Method of measurement: Based on a chek-list related to placement a peripheral Intravenous line in pediatric.</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>Vice chancellor for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-12</approval_date>
        <contact_name>Tabriz University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Golgasht st؛Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
