<?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>IRCT20200519047512N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-16</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of blinking exercise training on sign and symptoms of dry eye syndrome</public_title>
      <acronym>EBETSDES</acronym>
      <scientific_title>Effect of blinking exercise training on sign and symptoms of dry eye syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48474</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: , Randomization description: In the block method, the volume of each block must first be specified. In this study, groups can be in three states It has been replaced in the form of  ABC(1), BCA(2), CBA(3), BAC(4), ACB(5), CAB(6) Which are randomly selected
And are placed in 24 blocks of 6 to complete each block. All block randomization steps using From matlab software by a statistician Perform and list samples It will be given to the researcher, Blinding description: Sampling, completion of pre-test questionnaires and training of groups A and B are performed by the facilitator.
In order to prevent bias post-test information, post-test questionnaires are completed by a research colleague who is unaware of intervention groups A, B and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dry eye.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For Intervention Group A patients, a training program on dry eye disease, self-care, medication use, and compliance with items that control the symptoms and signs of the disease, as well as effective eyelid blinking by the instructor taught them They are asked to repeat this operation several times, then its accuracy is evaluated and confirmed by the researcher. Intervention 2: Intervention group:  Second Intervention Group: In order to investigate the effect of active blinking on the signs and symptoms of dry eye, to a group of patients (group B), only training related to recognizing dry eye disease, self-care, and medication use (as in group A patients). ) Provided by the executor.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kurosh Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payambar Aazam (SAW) University complex, Basij Squ., Sardasht region</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3914334911</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>s.khademi9511@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Khademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payambar Aazam (SAW) University complex, Basij Squ., Sardasht region</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3914334911</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>s.khademi9511@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Dry eye should be confirmed by the diagnosis of an ophthalmologist using clinical signs and symptoms, a schirmer test, and tear break up time.
Has been treated for at least 6 months.
Age 15-51 years old.
Do not use systemic drugs with associated eye effects.(such as β   - blockers  Diuretics, Antihistamines, TCAs, androgens, Isotretinoin
Do not have primary, secondary, or obstructive insufficiency Tear glands.
Do not undergo eye surgery.
Do not have thyroid disorders.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>51 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If do not do more than third Practice during the day (The patient is asked).
Death or transfer of residence.
Having any disease that requires medication, hospitalization, or surgery.
Get any new eye problems.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H04.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dry eye syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For Intervention Group A patients, a training program on dry eye disease, self-care, medication use, and compliance with items that control the symptoms and signs of the disease, as well as effective eyelid blinking by the instructor taught them They are asked to repeat this operation several times, then its accuracy is evaluated and confirmed by the researcher.</i_keyword>
      <i_keyword>Intervention group:  Second Intervention Group: In order to investigate the effect of active blinking on the signs and symptoms of dry eye, to a group of patients (group B), only training related to recognizing dry eye disease, self-care, and medication use (as in group A patients). ) Provided by the executor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dry eye score in the OSDI questionnaire. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: OSDI questionnaire.</prim_outcome>
      <prim_outcome>Dry eye rate in schirmer test and tear break up time. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: schirmer test.</prim_outcome>
      <prim_outcome>Dry eye rate in tear break up time. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: Tear break up time test.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-16</approval_date>
        <contact_name>Arak University of Medical sciences</contact_name>
        <contact_address>Payambar Aazam (SAW) University complex,  Basij Squ., Sardasht region Saveh Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
