<?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>IRCT20180622040189N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-15</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of two methods of listening and reading tales on anxiety and sleep onest time</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two methods of listening and reading tales on anxiety and sleep onest time in 8-12 year old in hospitalized children  with fractures: a randomized controled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33617</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Samples are selected using the available method. In the next step, random blocks with 3 sets are assigned to two test groups and one control group. A random sequence is generated using the STATA14 software. Number of blocks 34, size 3.
After blocking, patients (individuals)  will assign to study groups by main researcher using generated randomized sequential as  they will recruit.like this:
A: First intervention group
B: Second intervention group
C: control group
First person                          1	  A
                                              2	  B
                                              3	  C
                                               1	  C
                                               2	  A
                                               3 	  B
                                               1	  C
                                               2         B
                                               3         A
                                                .          .
                                                .          .
                                                .          .
                                                .          .
                    
                                                1         C 
                                                2         B
 person  102                           3        A.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Comparison of the Effect of Two Methods of Listening and Reading Tales on Anxiety and Sleep Onest Time in 8-12 Year Old in Hospitalized Children  with Fractures.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group heard the story:on the evening of the second day (day of operation), a heart rate measurement was first performed,then the player's headphones are provided to the child and he listens to the researcher's story book stories for 30 minutes.Then the heart rate is recorded and the RCMAS children's apparent anxiety questionnaire (with the exception of polygraph questions) is completed.In the bedtime  of the children,the final visit is done,player's headphones available to the child,and child listens to storytelling for 30 minutes in the presence of a researcher, and the time taken from the beginning of the story will be recorded until the child falls asleep. Intervention 2: Intervention group: listening and reading the story text simultaneously.The actions performed in this group are like the first group, with the difference that during this intervention, in addition to listening to story, the group also uses the look at story text at the same time.on the evening of the second day (day of operation), a heart rate measurement was first performed,then the story book is available to the child,and for 30 minutes, in the presence of a researcher, while listening to the same story while using the headphone player, the story book is also viewed and followed by the child,then the heart rate is recorded and the RCMAS children's apparent anxiety questionnaire (with the exception of polygraph questions) is completed.In the bedtime of the children,the final visit is done,the story book is available to the child and for 30 minutes in the presence of a researcher while listening to the same tale while using the headphone player the story book is also viewed and followed by the child , and the time taken from the beginning of the story will be recorded until the child falls asleep. Intervention 3: Control group: In this group, the researcher visits the department for two consecutive days (including the day of admission and day of operation) and twice a day (evening and night), but there is no intervention. In the evening of the admission day, the researcher's assistance, the number of pulses is determined and recorded by using the pulse oximeter. Then, children listen to story by the player's headphones for 30 minutes. After that, the heart rate is recorded and the questionnaire is completed. On the evening of the second day (day of operation), the heart rate will be measured. The re-connection takes place at 10 o'clock and the length of sleep time will be measured. On the second day (day of operation), the heart rate is recorded twice with a half an hour interval and the time to fall asleep is measured and recorded.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Romouzi Kouche Bagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, Shariati Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947978</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>azambagh111@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leyla Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, Shariati Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947978</zip>
        <telephone>+98 41 3479 6770</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>Not having a history of sleep disorder
Not having anxiety disorder</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unaccompanied patient
A patient who has multiple trauma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention group: The intervention group heard the story:on the evening of the second day (day of operation), a heart rate measurement was first performed,then the player's headphones are provided to the child and he listens to the researcher's story book stories for 30 minutes.Then the heart rate is recorded and the RCMAS children's apparent anxiety questionnaire (with the exception of polygraph questions) is completed.In the bedtime  of the children,the final visit is done,player's headphones available to the child,and child listens to storytelling for 30 minutes in the presence of a researcher, and the time taken from the beginning of the story will be recorded until the child falls asleep.</i_keyword>
      <i_keyword>Intervention group: listening and reading the story text simultaneously.The actions performed in this group are like the first group, with the difference that during this intervention, in addition to listening to story, the group also uses the look at story text at the same time.on the evening of the second day (day of operation), a heart rate measurement was first performed,then the story book is available to the child,and for 30 minutes, in the presence of a researcher, while listening to the same story while using the headphone player, the story book is also viewed and followed by the child,then the heart rate is recorded and the RCMAS children's apparent anxiety questionnaire (with the exception of polygraph questions) is completed.In the bedtime of the children,the final visit is done,the story book is available to the child and for 30 minutes in the presence of a researcher while listening to the same tale while using the headphone player the story book is also viewed and followed by the child , and the time taken from the beginning of the story will be recorded until the child falls asleep.</i_keyword>
      <i_keyword>Control group: In this group, the researcher visits the department for two consecutive days (including the day of admission and day of operation) and twice a day (evening and night), but there is no intervention. In the evening of the admission day, the researcher's assistance, the number of pulses is determined and recorded by using the pulse oximeter. Then, children listen to story by the player's headphones for 30 minutes. After that, the heart rate is recorded and the questionnaire is completed. On the evening of the second day (day of operation), the heart rate will be measured. The re-connection takes place at 10 o'clock and the length of sleep time will be measured. On the second day (day of operation), the heart rate is recorded twice with a half an hour interval and the time to fall asleep is measured and recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety Score in Revised Children's Manifest Anxiety Scale. Timepoint: Completion of the anxiety questionnaire on the first day after pulse control and the second day after intervention. Method of measurement: Revised Children's Manifest Anxiety Scale.</prim_outcome>
      <prim_outcome>Time to fall asleep children. Timepoint: The first night after 21:30 and the second night after the intervention. Method of measurement: chronometer.</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>2018-07-22</approval_date>
        <contact_name>Regional Ethics College Committee for Biomedical Research, Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht Ave, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
