<?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>IRCT20190406043176N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-08</date_registration>
      <primary_sponsor>Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Visual Attention on Heart Rate Variability and Respiratory Rate Variability During White Noise</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Visual Attention on Heart Rate Variability and Respiratory Rate Variability During White Noise in Medical Students of Alborz University</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38601</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Basic scienece, Blinding description: Test participants are not aware of changes made independent variables.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention.</hc_freetext>
      <i_freetext>Intervention 1: Control group: First, for 20 minutes, the person taking the test is seated in the laboratory without any stimuli. In the second step, it will be recorded in the same non-stimulating state. Intervention 2: First intervention group: First, for 20 minutes, the person participating in the test will be seated without any stimuli in the laboratory space. Secondly, in the same state of sitting, the participant will receive a white noise sound (at a rate of about 70 dB) through the headphones for 20 minutes. Intervention 3: Second intervention group: First, for 20 minutes, the person participating in the test will be seated in a laboratory without any stimuli in the laboratory space. Secondly, in the same situation without sound, the participant will sit in the ANT test for 20 minutes. Intervention 4: Third intervention group: First, for 20 minutes, the person participating in the test will be seated without any stimuli in the laboratory space. In the second step, the participant sitting on the chair takes an ANT test for 20 minutes, and at the same time he receives hearing white noise through the headphones.</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:
The total data is potentially unobtrusive after being unidentifiable

When:
There will be general accessibility after publication.

To whom:
The data for this research will only be available to researchers working in academic and scientific institutions

Conditions:
These data can use for different analyzes of heartbeat or breathing pattern

Where to obtain:
Roham Mazloom, Alborz University of Medical Sciences, Karaj, Iran.
rohammazloom@abzums.ac.ir

How to obtain:
After receiving the request, the information will be sent to the requesting person by e-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roham Mazloom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Alborz University of Medical Sciences, West Bouali Street, Moazen Boulevard</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3146883811</zip>
        <telephone>+98 26 3428 7315</telephone>
        <email>rohammazloom@abzums.ac.ir</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roham Mazloom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Alborz University of Medical Sciences, West Bouali street, Moazen Boulevard</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3146883811</zip>
        <telephone>+98 26 3428 7315</telephone>
        <email>rohammazloom@abzums.ac.ir</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-25 years
Medical students
Normal vision and audition</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Chronic disease
Professional athletes
Using of treatment and stimulants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disturbance of activity and attention</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: First, for 20 minutes, the person taking the test is seated in the laboratory without any stimuli. In the second step, it will be recorded in the same non-stimulating state.</i_keyword>
      <i_keyword>First intervention group: First, for 20 minutes, the person participating in the test will be seated without any stimuli in the laboratory space. Secondly, in the same state of sitting, the participant will receive a white noise sound (at a rate of about 70 dB) through the headphones for 20 minutes.</i_keyword>
      <i_keyword>Second intervention group: First, for 20 minutes, the person participating in the test will be seated in a laboratory without any stimuli in the laboratory space. Secondly, in the same situation without sound, the participant will sit in the ANT test for 20 minutes.</i_keyword>
      <i_keyword>Third intervention group: First, for 20 minutes, the person participating in the test will be seated without any stimuli in the laboratory space. In the second step, the participant sitting on the chair takes an ANT test for 20 minutes, and at the same time he receives hearing white noise through the headphones.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate variability. Timepoint: Measurement of dynamic heart rate changes in the first 20 minutes and the second 20 minutes with the research process in each group. Method of measurement: Electrocardiogram recording via analog to digital conversion device the BIODAC ER21 model, Trita Healthcare Technology Company, will be  analyzed through the MATLAB program.</prim_outcome>
      <prim_outcome>Respiratory rate variability. Timepoint: Measurement of dynamic respiratory rate changes in the first 20 minutes and the second 20 minutes with the research process in each group. Method of measurement: Respiratory pattern recording via analog to digital conversion device the BIODAC ER21 model, Trita Healthcare Technology Company, will be  analyzed through the MATLAB program.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Linear indices. Timepoint: First 20 minutes and second 20 minutes. Method of measurement: MATLAB Software.</sec_outcome>
      <sec_outcome>Nonlinear indices. Timepoint: First 20 minutes and second 20 minutes. Method of measurement: MATLAB Software.</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>Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-26</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>North Taleghani Boulevaed, Alborz University of Medical Sciences Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
