<?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>IRCT20140721018550N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-18</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of interactive playing on the anxiety before orthopedic surgery in children</public_title>
      <acronym>---</acronym>
      <scientific_title>Investigating the effect of interactive playing on the intensity of anxiety before orthopedic surgery in children 4 - 6 year</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67794</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this research, for the interactive playing, we will use the scenario designed by the research team, which uses a glove filled with water, the story is told by the researcher, and the child paints the items on each finger of the glove with a magic marker, Randomization description: We use convenience sampling, but the samples will be allocated to intervention and control groups in the form of random blocks of four using the sealed envelope site.
To ensure matching between the two groups as well as to achieve a completely random and balanced assignment, we will use a randomized classification using Stratified permuted block randomization. Individuals are then divided into two stratum of male and female, and for each class a separate random assignment is continued until the sample size is reached. For random assignment in each class based on different sequences of two methods A (intervention) and B (control), 4 blocks are defined and numbered from left to right from 1 to 4. Then using 1 to 4 random blocks of blocks are randomly selected. Thus, the assignment type is determined from left to right, respectively. Since we need 30 subject in each group, we have to randomly select the block 8 times for that class).</study_design>
      <phase>3</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  On the day of surgery, pulse, blood pressure, and blood oxygen saturation percentage of children in the intervention group with the same equipment in the presence of the child's mother and their anxiety with the preoperative anxiety scale of Yale University and visual analog scale (VAS) by a trained colleague of the project , it is measured and recorded. Then, using gloves filled with water and a magic marker that he gives to the child, the main researcher narrates the scenario designed by the research team and in several stages asks the child to identify parts of the face. Draw on each finger of the glove. At the end, for the second time, the aforementioned indicators are measured and recorded by the colleague of the project from the same arm as before and with the same instrument, and the child's anxiety is measured and recorded with the preoperative anxiety scale of Yale University and the visual analog scale (VAS). Intervention 2: Control group: On the day of surgery, pulse, blood pressure, and blood oxygen saturation percentage of children in the intervention group with the same equipment in the presence of the child's mother and their anxiety with the preoperative anxiety scale of Yale University and visual analog scale (VAS) measured and recorded by a trained colleague of the project. No intervention was done for the control group and they were placed in a comfortable position on the bed for ten minutes, which is equivalent to the intervention time for the intervention group. At the end, for the second time, the aforementioned indicators are measured and recorded by the colleague of the project from the same arm as before and with the same instrument, and the child's anxiety is measured and recorded with the preoperative anxiety scale of Yale University and the visual analog scale (VAS).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is After the completion of the research, it will be provided upon written request.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nayyereh Raiesdana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery. Semnan University of Medical Sciences. 5th kilometer of Damghan road. Semnan. Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4190</telephone>
        <email>nr_dana@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nayyereh Raiesdana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Semnan university of Medical Sciences, 5th Kilometer of Damghan road,Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>+98233513138111</zip>
        <telephone>+98 23 3365 4190</telephone>
        <email>nr_dana@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The presence of the mother next to the child at the time of sampling
No history of entering the operating room for any reason
Closed fracture in any of the lower limbs or non-dominant upper limbs of the child
Absence of mental and cognitive developmental disorders
Not suffering from hyperactivity disorder or autism
Pain score less than 6 according to the Wong Baker scale</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation
Inability to continue intervention for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified mental disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  On the day of surgery, pulse, blood pressure, and blood oxygen saturation percentage of children in the intervention group with the same equipment in the presence of the child's mother and their anxiety with the preoperative anxiety scale of Yale University and visual analog scale (VAS) by a trained colleague of the project , it is measured and recorded. Then, using gloves filled with water and a magic marker that he gives to the child, the main researcher narrates the scenario designed by the research team and in several stages asks the child to identify parts of the face. Draw on each finger of the glove. At the end, for the second time, the aforementioned indicators are measured and recorded by the colleague of the project from the same arm as before and with the same instrument, and the child's anxiety is measured and recorded with the preoperative anxiety scale of Yale University and the visual analog scale (VAS).</i_keyword>
      <i_keyword>Control group: On the day of surgery, pulse, blood pressure, and blood oxygen saturation percentage of children in the intervention group with the same equipment in the presence of the child's mother and their anxiety with the preoperative anxiety scale of Yale University and visual analog scale (VAS) measured and recorded by a trained colleague of the project. No intervention was done for the control group and they were placed in a comfortable position on the bed for ten minutes, which is equivalent to the intervention time for the intervention group. At the end, for the second time, the aforementioned indicators are measured and recorded by the colleague of the project from the same arm as before and with the same instrument, and the child's anxiety is measured and recorded with the preoperative anxiety scale of Yale University and the visual analog scale (VAS).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after intervention. Method of measurement: 1-The Yale Preoperative Anxiety Scale and 2-Visual analog scale of children's anxiety.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic and Diastolic Blood Pressure. Timepoint: Before and after intervention. Method of measurement: Digital Sphygmomanometer.</sec_outcome>
      <sec_outcome>Pulse beat. Timepoint: Before and after intervention. Method of measurement: Wellex portable pulse oximeter model A310 made in Germany.</sec_outcome>
      <sec_outcome>Oxygen saturation percentage. Timepoint: Before and after intervention. Method of measurement: Wellex portable pulse oximeter model A310 made in Germany.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-26</approval_date>
        <contact_name>Ethic committee of Semnan University of Medical sciences</contact_name>
        <contact_address>Basij Blvd. Central Office of Semnan university of Medical sciences. Semnan. Iran Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
