<?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>IRCT20161112030846N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-03</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Determining the effect of dim regulation by devices radiating according to natural circadian sunlight shifts</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Radiance-Dimmer Devices Simulating Natural Sunlight Rhythm on the Plasma Melatonin Levels and Anxiety and Depression Scores of the Submarine Personnel</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24390</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The members of the two bunch of staff were randomly divided into two experimental and control groups. Participants in the two groups did not differ significantly in terms of demographic characteristics such as gender, age, and educational level. In each group, 26 patients were tested and controlled.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and Depressive.</hc_freetext>
      <i_freetext>Intervention 1: experimental group,  In order to lighting the environment, 4 automatic optic devices were installed at the halls where personnel from the case group were working in, containing lamps expelling sunlight and moonlit with radiant intensity were 400 lox. These optic devices were automatic and turned on since 6 am automatically , which were approximate time of sunrise, and in a modal that conformities with increment of natural radiance of sunlight, 68 lox added to their radiant intensity every hour, so that radiant intensity of these optic regulators reach to its radiant proxy at 12:00 o’clock which means 400 lox for each regulator device, and subsequently reducing their radiant intensity at a rate about 68 lox an hour, and at a result, the light would have been turned off at 6 o’clock PM, almost conformed with approximate time of the sunset. Intervention 2: Control group: the control group continued their experience with constant artificial light during the same time period. After this time, the study variables were reanalyzed and compared to the baseline values.</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:
Article is publishedWill be published in paper.

When:
2018

To whom:
Researchers and academics

Conditions:
It is possible to mention the source of the research article

Where to obtain:
An article that will be published will be available.

How to obtain:
An article that will be published will be available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khodabakhsh Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikhbahaie St. Mollasadra Ave.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8248 2712</telephone>
        <email>kh_ahmady@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khodabakhsh Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikhbahaie St. Mollasadra Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8248 2712</telephone>
        <email>kh_ahmady@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Underground employees who use artificial light only during the period of their presence
No specific disease or chronic physical and mental illness
Male
Have at least 21 and a maximum of 30 years</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Taking medications that could affect serum melatonin levels including
Having depression or any other major psychiatric disorders on DSM IV
Having significant acute or chronic systemic disorders including type I diabetes mellitus, uncontrolled thyroid disorders, kidney/prostate/bladder problems which cause excessive urination, congestive heart failure, angina pectoris or other major cardiovascular disorders, hepatitis, asthma or severe respiratory allergies, stroke, Parkinson’s disease, Alzheimer’s disease, schizophrenia, epilepsy, oncologic disorders if less than 1 year since end of treatment, or chronic infections
Use of hypnotics, melatonin, stimulants, or other medications that may affect melatonin levels (e.g. β blockers, drugs that affect prostaglandin synthesis, or drugs that activate hepatic melatonin metabolism) and unwillingness or inability to discontinue the occasional use of these medications for at least 4 weeks before beginning of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>experimental group,  In order to lighting the environment, 4 automatic optic devices were installed at the halls where personnel from the case group were working in, containing lamps expelling sunlight and moonlit with radiant intensity were 400 lox. These optic devices were automatic and turned on since 6 am automatically , which were approximate time of sunrise, and in a modal that conformities with increment of natural radiance of sunlight, 68 lox added to their radiant intensity every hour, so that radiant intensity of these optic regulators reach to its radiant proxy at 12:00 o’clock which means 400 lox for each regulator device, and subsequently reducing their radiant intensity at a rate about 68 lox an hour, and at a result, the light would have been turned off at 6 o’clock PM, almost conformed with approximate time of the sunset.</i_keyword>
      <i_keyword>Control group: the control group continued their experience with constant artificial light during the same time period. After this time, the study variables were reanalyzed and compared to the baseline values.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: 3 TIMES: Initiation, Middle and End of the study period. Method of measurement: Cattell’s Anxiety Scale Questionnaire (IPAT).</prim_outcome>
      <prim_outcome>Depression. Timepoint: 3 TIMES: Initiation, Middle and End of the study period. Method of measurement: Minnesota Multiple Personality Inventory (MMPI).</prim_outcome>
      <prim_outcome>Plasma melatonin hormone. Timepoint: 3 TIMES: Initiation, Middle and End of the study period. Method of measurement: Blood examination.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-15</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>SheikhBahaie St. Mollasadra Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
