<?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>IRCT20231208060294N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-18</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effect of deep breathing on sleep quality, anxiety and depression</public_title>
      <acronym></acronym>
      <scientific_title>The effect of deep breathing on sleep quality, anxiety, and depression in patients undergoing coronary artery bypass graft surgery at Shafa Health Center affiliated to Kerman University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74222</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Other design features: Intervention and control groups, Randomization description: In this study, block randomization method is used using free software (Random Allocation Software). Because the general population of patients is not known and the study is prospective, the best method of randomization for this research was block randomization. Blocking is used in order to balance the number of samples allocated to each of the studied groups. The size of the blocks is equal, but more than the number of sample volume is produced so that if it is necessary to enter a larger number of samples, the sequence will not be disturbed. Entry into the study will continue until the completion of the set number for both groups, and if a person is removed from one group during the study, intervention and follow-up will be replaced by the next person from the sequence of blocks. The production of random blocks was done by one of the researchers of the project who has no direct relationship with the patients and their assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiac surgery.</hc_freetext>
      <i_freetext>Intervention group:  In the intervention group, after receiving training, patients perform Amin's breathing before the operation, immediately after the operation, 15 days after the operation, and one month after the operation for 10 minutes every three hours..</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:
After publishing the results of the study , the authors can send their request to the responsible author so that they can use the data of the study. All data is potentially shareable after de-identifying individuals

When:
After publishing the results of the study , the authors can send their request to the responsible author so that they can use the data of the study.

To whom:
After publishing the results of the study , the authors can send their request to the responsible author so that they can use the data of the study. All data is potentially shareable after de-identifying individuals. The data will be accessible only to researchers working in academic and scientific institutions

Conditions:
Researchers can use the study questionnaires by sending an email to the responsible author, and they can also receive the SPSS file of the data by maintaining confidentiality.

Where to obtain:
Corresponding author, Mrs. Mansooreh Azizzadeh Frouzi
email:  forozy@gmail.com

How to obtain:
After the publication of the study results, the authors can send their request to the responsible author so that they can use the study data. The requested information will be sent within two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansooreh Azizadeh Forouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>haftbaq highway- Kerman university of medical sciences</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>forozy@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansooreh Azizzadeh Forouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh Alavi Bolv, Kerman university of Medical Sciences</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3213 4106</telephone>
        <email>forozy@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to read and write and use a mobile phone
Stability of hemodynamic symptoms
Absence of neurological problems
Hospitalization of the patient at least one day before surgery</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of mental disorders (depression, anxiety), sleep disorders before surgery (reported by the patient
Using sleeping pills or sleeping scents
Having a hearing impairment
Having a history of progressive chronic diseases such as kidney failure and uncontrolled diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of aortocoronary bypass graft</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In the intervention group, after receiving training, patients perform Amin's breathing before the operation, immediately after the operation, 15 days after the operation, and one month after the operation for 10 minutes every three hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of sleep quality that is less than 5 is between 0 and 21. Timepoint: In this study, the quality of sleep and anxiety and depression of open heart surgery patients will be evaluated before the intervention, immediately after the intervention, 15 days later and one month after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</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>معاونت تحقیقات دانشگاه علوم پزشکی کرمان</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-11</approval_date>
        <contact_name>Ethic Commite of Kerman University of Medical Sciences</contact_name>
        <contact_address>No. 2. Haft Bagh Alavi Bolv, Kerman university of medical sciences kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
