<?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>IRCT20130617013691N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-11</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of deep breathing, feet off gig  and combining them on intensity of venipuncture pain and physiological parameters in school age children-A randomized clinical trial</public_title>
      <acronym>-</acronym>
      <scientific_title>The effects of deep breathing, feet off the gig and combining them on intensity of venipuncture pain and Heart Rate and Pulse Oximetry  in school age children-A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13485</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random sampling will be available, so that by using a randomized table, children will be randomly assigned to one of four groups. Assignment Sequences are determined using a computer random number table (www.Random.com), and in order to hide the allocation, the opaque packets are numbered sequentially, Blinding description: No blinding.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain intensity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the combined group (deep breathing and hypnosis), the pain intensity and physiological indices are measured 3 minutes before the insertion and recorded in the questionnaire. One minute before the trampling, it is done by a deep tail with a nose and will die in the exhalation of the gingival, and after the death of the gig, the numbers will count up to 10 spins and 10 breaths. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers. Intervention 2: Intervention group: In the deep breathing group, the pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. One minute before the pregnancy, a deep tail with a nose is done and the mouth is exhausted, and after each breath, the numbers will count up to 10 breaths. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers. Intervention 3: Intervention group: In the gig group, the pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. A minute before the tuneup, the gig will die, and after the death of the gig, numbers will count up to 10 rotations. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers. Intervention 4: Control group: Control group: The pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. The insertion is done and the measurement of pain intensity and physiological parameters is recorded 3 minutes after the insertion and recorded in the questionnaire.</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:
Individual characteristics of the samples (age, sex, grade of birth, degree of education, parents' education and literacy, place of residence, hospitalization history, number of family members, location of the venue, frequency and economic status), and the form of registration of pain after ineligible Identifying people to be shared.

When:
Start the access period, 6 months after printing the results

To whom:
Data will be available to researchers working in academic and academic institutions

Conditions:
Use of the data provided for performing statistical analyzes is permitted

Where to obtain:
Contact us at hoabdolalizadeh@gmail.com to receive the data.

How to obtain:
After receiving the email from the email address listed, the data will be sent after 24 hours.

Comments:
I have no other explanation.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Horiyeh Abdolalizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5391835196</zip>
        <telephone>+98 935 759 1402</telephone>
        <email>hoabdolalizadeh@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Arshadi Bostanabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Sharyati Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519653918</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>arshadi@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 child is 12-6 years of age.
The cadence is to count the numbers from 1 to 10.
A child is aware that there is a possibility of questions and answers.
Children and parents tend to cooperate.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any life-threatening illness
Use Housing to relieve pain
Catheter more than once into the skin
Taking sedative medications and anticonvulsants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In the combined group (deep breathing and hypnosis), the pain intensity and physiological indices are measured 3 minutes before the insertion and recorded in the questionnaire. One minute before the trampling, it is done by a deep tail with a nose and will die in the exhalation of the gingival, and after the death of the gig, the numbers will count up to 10 spins and 10 breaths. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers</i_keyword>
      <i_keyword>Intervention group: In the deep breathing group, the pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. One minute before the pregnancy, a deep tail with a nose is done and the mouth is exhausted, and after each breath, the numbers will count up to 10 breaths. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers.</i_keyword>
      <i_keyword>Intervention group: In the gig group, the pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. A minute before the tuneup, the gig will die, and after the death of the gig, numbers will count up to 10 rotations. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers.</i_keyword>
      <i_keyword>Control group: Control group: The pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. The insertion is done and the measurement of pain intensity and physiological parameters is recorded 3 minutes after the insertion and recorded in the questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The intensity of the pain. Timepoint: 3 minutes before and 3 minutes after  Iv line. Method of measurement: OUCHER pain tools.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physiological parameters. Timepoint: 3 minutes before and 3 minutes after the Iv line. Method of measurement: Pulsoxymetry devices.</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>2017-05-22</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>South Sharyati Ave Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
