<?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>IRCT20090908002432N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-17</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Psycho-Educational Interventions on Anxiety, Physiological Indicators and Pain after the Surgery in the Coronary Artery Bypass Graft Patients</public_title>
      <acronym>--</acronym>
      <scientific_title>The Effect of Psycho-Educational Interventions on Anxiety, Physiological Indicators and Pain after the Surgery in the Coronary Artery Bypass Graft Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55652</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The present study is performed on 56 patients volunteered for coronary artery bypass graft surgery who are eligible to enter the study. Samples were selected through target-based sampling method until reaching the desired sample size and then samples were divided into two groups of experimental and control by random allocation method using RA software. Psycho-educational interventions were placed in three training sessions in the morning or evening the day before surgery and routine sedatives were given individually and face to face.  Brochures were given to patients for study. Educational interventions included (effective breathing exercises after heart surgery and the way to use spirometry, self-care training and nutritional care after surgery, giving information about the process of the disease and treatment, routine medications after surgery and their side effects, surgery site, stitches and chest tube care training). Psychological interventions included: five mindfulness exercises trainings (conscious breathing, conscious observation, conscious listening, conscious awareness, conscious appreciation). There is no intervention for the control group. Spielberger questionnaire and McGill inventory will completed by the patient after surgery and before discharge. Physiological parameters of the patients, Randomization description: First, we will pick up the people who has the inclusion criteria based on their profiles and get a number to each one. Then, we will randomly select 56 of them with the random number software. We will use the randomized permutation block design with the size of 4 to allocate them into the two groups of intervention (n=28) and control (n=28), Blinding description: Control and intervention group members should not be in the same room or close to each other so that the sound of training would not heard by the control group. We will ask the control group not to share the training with other patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Pain. Condition 2: Anxiety. Condition 3: Physiological  indexes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Psycho-educational interventions will perform in 3 sessions alongside prescribing routine sedatives face to face before surgery. An educational brochure will give to patients. Educational interventions are including effective breathing exercises after heart surgery, spirometer use techniques, self-care training, nutritional care after surgery, giving information about the course of disease and treatment, routine medications after surgery and their side effects, training to take care of the surgical site, stitches and chest tube. Mental interventions including conscious breathing, conscious observation, conscious listening, conscious mindfulness, conscious appreciation. Intervention 2: Control group: There is no intervention for the control group. Spielberger questionnaire and McGill inventory will completed by the patient after surgery and before discharge. Physiological parameters of the patients will measure and record by the research assistant.</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:
-

When:
-

To whom:
-

Conditions:
--

Where to obtain:
-

How to obtain:
-

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>00987136474258  00987136474252</telephone>
        <email>amiriea@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>00987136474258   00987136474252</telephone>
        <email>amiriea@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient candidates for coronary artery bypass graft surgery
No history of heart surgery
Having literacy of reading and writing
Ages between 18 to 65 years
Willing to participate in the study
Participating in pre-test assessment and having a minimum level of mild anxiety
No history of antidepressants use
No physical disabilities and no mental illnesses
No participation in similar studies</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation after the surgery
Postoperative fever and infection
Any problems during anesthesia and surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Psycho-educational interventions will perform in 3 sessions alongside prescribing routine sedatives face to face before surgery. An educational brochure will give to patients. Educational interventions are including effective breathing exercises after heart surgery, spirometer use techniques, self-care training, nutritional care after surgery, giving information about the course of disease and treatment, routine medications after surgery and their side effects, training to take care of the surgical site, stitches and chest tube. Mental interventions including conscious breathing, conscious observation, conscious listening, conscious mindfulness, conscious appreciation.</i_keyword>
      <i_keyword>Control group: There is no intervention for the control group. Spielberger questionnaire and McGill inventory will completed by the patient after surgery and before discharge. Physiological parameters of the patients will measure and record by the research assistant.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of anxiety. Timepoint: Before intervention, during admission and after intervention. Method of measurement: Spielberger state-trait anxiety questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before intervention, during admission and after intervention. Method of measurement: McGill Scale.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-27</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand Street, Shiraz. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
