<?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>IRCT20230116057134N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-10</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of auriculotherapy education on anxiety, sleeps quality, pain and hemodynamic parameters of patients after Coronary artery bypass graft surgery (CABG)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of auriculotherapy education on anxiety, sleeps quality, pain and hemodynamic parameters of patients after Coronary artery bypass graft surgery (CABG)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>164</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68312</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Research participants will be randomly divided into two intervention groups and control groups. The randomization unit will be the participants. For blinding, one letter is assigned to each group (A: ear acupressure intervention group and B: comparison group). Then with the help of the online method on the site https://www.sealedenvelope.com/simple-randomiser/v1/lists or using the random allocation2 software and without individual intervention, the allocation sequence will be created. Then, to hide the allocation sequence, the sequence is written on the sheets and placed in sealed envelopes in order, Blinding description: A placebo group will be used for blinding. The placebo group will be visited like the intervention group. The researcher will stick the skin patches without Vaccaria seeds on the skin of the ear, will be present at the patient's bedside and will talk to the patient. In the placebo group, irrelevant points of the ear are pressured, even though it is insignificant, none of the two groups know which group they will be in.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Investigating the effect of ear acupressure training on anxiety of patients after coronary artery bypass surgery. Condition 2: Investigating the effect of ear acupressure training on sleep quality of patients after coronary artery bypass surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Auricular acupressure intervention using special adhesives containing vaccaria seeds on points of the ear (Shen Men, zero point, pelvis, abdomen, endocrine, uterus) which is effective on anxiety, pain intensity, sleep quality and hemodynamic indicators of patients. is glued The intervention will be carried out by the researcher from one day before the surgery and up to three days after the surgery four times during the day (three times in the morning and once in the evening) and each of the points will be compared for one minute with The finger is pressed. The material used in this study is special auriculotherapy adhesives containing vaccaria seeds, which is a product of China. This product will be available from medical equipment stores. Intervention 2: Control group: They will be visited similarly to the intervention group. The researcher pastes skin patches without Vaccaria seeds on the skin of the ear. And he will only be present at the patient's bedside and talk to the patient. In the placebo group, irrelevant points of the ear are pressured, although slightly.</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 اطلاعات بیشتری وجود ندارد</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hosseini Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari Medical School - Km 18 Khazarabad Road</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91628 - 48471</zip>
        <telephone>+98 11 3354 3089</telephone>
        <email>drhoseininejad@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hosseini Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari Medical School - Km 18 Khazarabad Road</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91628 - 48471</zip>
        <telephone>+98 11 3354 3089</telephone>
        <email>drhoseininejad@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years and above
Not having any history of taking psychiatric drugs (delirium, insomnia, etc.), based on the medical history and by reviewing the patient's hospitalization file and looking at the patient's medications
Patients under general anesthesia (by reading the patient procedure description sheet, after surgery, which is available in the patient file)
Using only ibuprofen pain reliever based on the department's routine in the form of 400 mg every 8 hours (they should not use Gellophane 4 hours before the intervention)
Creatinine in the range of 1.2 - 0.7 mg/DL</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any history of eczema, dermatitis, etc.
Complications of surgery include bleeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
      <hc_code>G47.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
      <hc_keyword>Insomnia due to medical condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Auricular acupressure intervention using special adhesives containing vaccaria seeds on points of the ear (Shen Men, zero point, pelvis, abdomen, endocrine, uterus) which is effective on anxiety, pain intensity, sleep quality and hemodynamic indicators of patients. is glued The intervention will be carried out by the researcher from one day before the surgery and up to three days after the surgery four times during the day (three times in the morning and once in the evening) and each of the points will be compared for one minute with The finger is pressed. The material used in this study is special auriculotherapy adhesives containing vaccaria seeds, which is a product of China. This product will be available from medical equipment stores.</i_keyword>
      <i_keyword>Control group: They will be visited similarly to the intervention group. The researcher pastes skin patches without Vaccaria seeds on the skin of the ear. And he will only be present at the patient's bedside and talk to the patient. In the placebo group, irrelevant points of the ear are pressured, although slightly</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Assessment of patients' anxiety after coronary artery bypass surgery. Timepoint: Evaluation of patients' anxiety in two intervention and control groups immediately after the intervention and four days after the intervention. Method of measurement: The use of Spiel Berger questionnaire.</prim_outcome>
      <prim_outcome>Evaluation of sleep quality of patients after coronary artery bypass surgery. Timepoint: Evaluation of sleep quality of patients in two intervention and control groups immediately after the intervention and four days after the intervention. Method of measurement: The use of Saint Mary's questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Assessment of pain intensity in patients after coronary artery bypass surgery. Timepoint: Evaluation of pain intensity of patients in two intervention and control groups immediately after the intervention and four days after the intervention. Method of measurement: The use of Visual Analogue pain Scale.</sec_outcome>
      <sec_outcome>Evaluation of hemodynamic indicators of patients after coronary artery bypass surgery. Timepoint: Evaluation of hemodynamic indicators of patients in two intervention and control groups immediately after the intervention and four days after the intervention. Method of measurement: Use of monitoring device.</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>Deputy Research and Technology- Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-16</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>The headquarters of Mazandaran University of Medical Sciences, Imam Square (RA), the beginning of Valiasr Highway (AJ) Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
