<?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>IRCT20191020045168N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-25</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of standard positioning effects of  standard positioning on Physiological responses and pain in operated infants in NICU</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of standard positioning effects of  standard positioning on Physiological responses and pain in operated infants in NICU of children’s Hospital : a crossover clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44143</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigation of standard positioning effects of  standard positioning on Physiological responses and pain in operated infants in NICU.</hc_freetext>
      <i_freetext>A nurse performs care procedures (baby changing probes, gavages, temperature measurements, etc.) on the baby, arranges the baby according to routine, the researcher 30 minutes, 15 minutes and immediately before and immediately, 15 and 30 minutes. The next minute, the physiological response is monitored and the pain score is assessed by the CRIES tool, and the nurse again carries out routine care procedures and arranges the baby, as soon as the baby leaves the baby, standardizing the position to the baby. The standard position will be maintained using the rolled towel. 30 minutes, 15 minutes and immediately before and immediately after, 15 minutes and 30 minutes after, the physiological responses were monitored and pain scores were assessed by the CRIES instrument.The distance between the first and second times is 24 hours in the evening shift. No procedures are performed on the baby within 30 minutes before and after scoring. The time of last analgesia and type of medication will be recorded. This study will work with each infant for two days for fixed procedures, fixed hours, and constant shifts to be measured..</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:
-

When:
-

To whom:
-

Conditions:
-

Where to obtain:
-

How to obtain:
-

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Ebrahimpoor Anbarloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isar Street. Isar 7.NO.7</address>
        <city>Ahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451657411</zip>
        <telephone>009844227173</telephone>
        <email>leila.ebrahimpoor1363@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, South Shariati Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>0474434796770</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>Neonates over 32 weeks of surgery and admitted to NICU Pediatric Hospital
Neonates  extubated after surgery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Transfer from NICU department to other department before sampling
Infant death before completing information
Perform restrictive surgeries and neck surgeries
Surgical neonates who are intubated after surgery.</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A nurse performs care procedures (baby changing probes, gavages, temperature measurements, etc.) on the baby, arranges the baby according to routine, the researcher 30 minutes, 15 minutes and immediately before and immediately, 15 and 30 minutes. The next minute, the physiological response is monitored and the pain score is assessed by the CRIES tool, and the nurse again carries out routine care procedures and arranges the baby, as soon as the baby leaves the baby, standardizing the position to the baby. The standard position will be maintained using the rolled towel. 30 minutes, 15 minutes and immediately before and immediately after, 15 minutes and 30 minutes after, the physiological responses were monitored and pain scores were assessed by the CRIES instrument.The distance between the first and second times is 24 hours in the evening shift. No procedures are performed on the baby within 30 minutes before and after scoring. The time of last analgesia and type of medication will be recorded. This study will work with each infant for two days for fixed procedures, fixed hours, and constant shifts to be measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physiological responses and pain. Timepoint: 30 minutes, 15 minutes and immediately before and immediately after, 15 minutes and 30 minutes later, controls physiological responses and scores with pain using the CRIES tool. The distance between the first and second times is 24 hours in the evening shift. No procedure is performed on the baby within 30 minutes before and after scoring. Method of measurement: CRIES pain tool.</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>2019-12-09</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>NO.7،West Isar،Alley Isar 7. tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
