<?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>IRCT20190727044341N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Diaphragmatic Respiratory Exercise Training on Clinical Symptoms, Quality of Life and Referral to physician in The Gastro-esophageal Reflux Patients (GERD)</public_title>
      <acronym>GERD</acronym>
      <scientific_title>The Effect of Diaphragmatic Respiratory Exercise Training on Clinical Symptoms, Quality of Life and Referral to physician in The Gastro-esophageal Reflux Patients (GERD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>146</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47194</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After the pre-test, patients will be randomly assigned to one of the intervention or control groups based on a table of random numbers. For this purpose, a list of patients with entry criteria will be prepared and no intervention will be done in the control group and diaphragmatic breathing exercises will be taught and performed in the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gastro-esophageal reflux disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group: No intervention will be made in this group. Intervention 2: Intervention group: Diaphragmatic breathing exercises will be taught and performed in the intervention group. The purpose of diaphragmatic breathing exercises in this study is to change chest breathing to abdominal breathing along with contraction of the patient's diaphragmatic muscles. The training includes the following: Explaining the purpose of diaphragmatic breathing exercises to the patient - The patient will be asked to be in an open position and place one hand on the chest and the other hand above the navel in the abdomen. - Teach the patient He will be able to breathe through the nose and exhale with his mouth open while only the abdomen moving up and down (the goal is for the abdomen to go up and down, while the shoulders and chest without The patient will be taught to perform the tail operation slowly by counting the numbers one to four and the exhalation operation by counting the numbers five to eight slowly. do it. If the patient has difficulty breathing, he or she will be taught how to breathe with the help of inhaled lips. Sit down and then stand up. The patient will be instructed to do the exercises three times a day, 30 breaths or five minutes at home each time.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amin Hosseini Sooreh Bargh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing and midwifery, Tohid square, Tehran</address>
        <city>Tehtan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>aminhosseini835@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amin Hosseini Sooreh Bargh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing and midwifery, Tohid square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>aminhosseini835@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for entering the study: Patients with second-degree gastroesophageal reflux disease who need medication in addition to lifestyle changes.
The desire to participate in the study
Age 20-60</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Criteria for not entering the study: the presence of other chronic diseases that affect quality of life (cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, cirrhosis, rheumatoid disease, a history of malignancy, scleroderma, diabetes and a history of stroke Brain)
Pregnancy
History of upper gastrointestinal surgery
BMI above 35 and below 18
Dissatisfaction with studying</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastro-esophageal reflux disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: No intervention will be made in this group.</i_keyword>
      <i_keyword>Intervention group: Diaphragmatic breathing exercises will be taught and performed in the intervention group. The purpose of diaphragmatic breathing exercises in this study is to change chest breathing to abdominal breathing along with contraction of the patient's diaphragmatic muscles. The training includes the following: Explaining the purpose of diaphragmatic breathing exercises to the patient - The patient will be asked to be in an open position and place one hand on the chest and the other hand above the navel in the abdomen. - Teach the patient He will be able to breathe through the nose and exhale with his mouth open while only the abdomen moving up and down (the goal is for the abdomen to go up and down, while the shoulders and chest without The patient will be taught to perform the tail operation slowly by counting the numbers one to four and the exhalation operation by counting the numbers five to eight slowly. do it. If the patient has difficulty breathing, he or she will be taught how to breathe with the help of inhaled lips. Sit down and then stand up. The patient will be instructed to do the exercises three times a day, 30 breaths or five minutes at home each time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical Symptoms: In this study, clinical symptoms will be measured using the Reflux Disease (RDQ) questionnaire. The Reflux Disease (RDQ) questionnaire includes questions about heartburn, regurgitation, and dyspnea based on the frequency and severity of symptoms. The scores of each question are in the Likert range from zero to five for the frequency and severity of the symptoms, and the higher the score of the questionnaire, the greater the severity of the symptoms or the greater the frequency of symptoms. Timepoint: Before the study, one and six months later. Method of measurement: Reflux Disease Questionnaire (RDQ).</prim_outcome>
      <prim_outcome>Quality of life: In this study, GERD-HRQL questionnaire is used to measure this variable. This questionnaire includes ten questions about the symptoms of the disease from 0 (asymptomatic) to 5 (inability to perform daily activities). The score from these ten questions ranges from zero (best) to 45 (worst). Timepoint: Before the study, one and six months later. Method of measurement: GERD-HRQL Questionnaire.</prim_outcome>
      <prim_outcome>Re-visit to the doctor: In this study, re-referral to the doctor will be reported using patients' self-report after the intervention and follow-up. Timepoint: Before the study, one and six months later. Method of measurement: Self-report.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-11</approval_date>
        <contact_name>Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
