<?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>IRCT20190727044347N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-14</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Emotional Freedom Technique on Sleep, Low Back Pain and Blood Pressure in  the Elderly patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of  Emotional Freedom Technique on Sleep, Low Back Pain and Blood Pressure in  the Elderly  Patient Hospitalized After Coronary Angiogaphy in Alzahra Cardiology  hospital  2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54356</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting eligible individuals to participate in the study based on inclusion criteria, these individuals will be assigned to two study groups based on double randomized permutation block with foursome blocks.
The random list is generated by a statistician using "Random Allocation" software.  Foursome blocks are the combination of different status such as: ABBA, BAAB, BABA, ABAB, BBAA, AABB. Using random list that is generated by computer, blocks are selected for forming the two study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hospitalized elderlies after angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: before angiography, the   emotional freedom technique  will be explained to the patients of the intervention group and they will be taught how to perform the intervention.The procedure is as follows: at each stage before the intervention, a short interview is conducted with the patient and the unpleasant factors that cause him discomfort in that situation, will be determined. Then, by focusing on these unpleasant situational factors, a series of indoctrination and positive sentences are taught to the patient, and the patient tries to accept his problem and relax himself by repeating these positive and indoctrination sentences.In addition, seven positive, non-annoying blows to each of the patient's meridian points are struck by the therapist or the patient himself while repeating the positive inductive sentences. The intervention group will receive the emotion release technique three times ،In this way, this technique will be performed once after angiography and immediately after the patient enters the ward. The second stage is the intervention one hour after the patient enters the ward and the third stage will be done at 20:00 that night. Intervention 2: Control group: The control group will receive routine care and  at the same intervals that the outcome variables are measured in the intervention group, they are also measured in the control group.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery (SA), Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71393613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>shirazi_1393@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery (SA), Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>shirazi_1393@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly Patients between 60 to 90 years old
Elderly patients admitted to the cardiac care units and  candidate for non-emergency angiography
People who want to participate in research and fill out the informed consent form
People who are fully aware and able to communicate
People who have not undergone other invasive procedures such as esophageal echocardiography before angiography.
Elderlies who have only angiography and do not have right heart catheterization
People undergoing coronary angiography for the first time</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having positive history of sleep disorders and taking medication before hospitalization based on the initial patient assessment form.
Having known cognitive and psychological disorders at the time of the study based on the initial patient assessment form.
Taking sedatives and analgesics before (8 hours before) and after angiography
The need for cardiopulmonary resuscitation during angiography.
Having visual impairment that prevents the selection of the correct position in the pain assessment tool (based on the initial patient assessment form).
Having active hemorrhage with hemodynamic disorders that resulted in blood transfusion during and after angiography.
Dangerous rhythm disorder immediately after catheterization.
Having low back pain on admission.
Addiction to drug, sedatives and alcohol drinks.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intraoperative and postprocedural complications and disorders of circulatory system, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: before angiography, the   emotional freedom technique  will be explained to the patients of the intervention group and they will be taught how to perform the intervention.The procedure is as follows: at each stage before the intervention, a short interview is conducted with the patient and the unpleasant factors that cause him discomfort in that situation, will be determined. Then, by focusing on these unpleasant situational factors, a series of indoctrination and positive sentences are taught to the patient, and the patient tries to accept his problem and relax himself by repeating these positive and indoctrination sentences.In addition, seven positive, non-annoying blows to each of the patient's meridian points are struck by the therapist or the patient himself while repeating the positive inductive sentences. The intervention group will receive the emotion release technique three times ،In this way, this technique will be performed once after angiography and immediately after the patient enters the ward. The second stage is the intervention one hour after the patient enters the ward and the third stage will be done at 20:00 that night.</i_keyword>
      <i_keyword>Control group: The control group will receive routine care and  at the same intervals that the outcome variables are measured in the intervention group, they are also measured in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The quality of sleep. Timepoint: The beginning of the study (before the intervention) and the day after the intervention. Method of measurement: The St. Mary's Hospital Sleep Questionnaire (SMHS).</prim_outcome>
      <prim_outcome>Low Back Pain. Timepoint: Patients' low back pain is measured before and after the three times intervention . The intervention will be performed once immediately after the patient enters the ward, once an hour later and the third stage will be performed at 8 pm on the same night. Patients in the control group at the same times set for the intervention group, the level of pain will be measured and recorded in two time intervals with an interval of 15 minutes. Method of measurement: Visual scale for pain intensity.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Patients' blood pressure is measured before and after the three times intervention. The intervention will be performed once immediately after the patient enters the ward, once an hour later and the third time will be performed at 8 pm on the same night. ّIn the control group at the same times set for the intervention group, blood pressure will be measured and recorded in two time intervals with an interval of 15 minutes. Method of measurement: Digital model amron 3 blood pressure monitor.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-26</approval_date>
        <contact_name>Research Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
