<?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>IRCT20191021045178N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-29</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the Emotional Freedom Techniques on fatigue, anxiety and symptoms burden of patients under hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>The assessment of effect of the Emotional Freedom Technique on fatigue, anxiety and symptoms burden of patients under hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75396</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Blinding description: For blinding in this study، The participants are unaware of the characteristics of the study groups. Data collection and completion of questions will be conducted by the first research assistant who does not know about the division of groups. It is also the statistician who does data analysis as blind to groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Kidney dialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After Informed consent and completing the questions by the intervention group، in a short interview with the patient, it is clear that the situation has caused unhappiness، Then with an unpleasant concentration, a series of positive and negative words are introduced to the patient in order to comfort themselves by those words. In our first phase in the intervention group, we want patients to say the positive and negative tree times like, (I'm always nervous about being dependent on the dialysis device, but I accept myself as I am) and every time they says that،  with the top of the middle finger hit to the karate chop point in the other hand Gently 7 times ، so that the dominant hand might bend over the wrist. At the next stage they said negative words (I'm always nervous about being dependent on the dialysis device) and hit  to the meridian points Including: the top of head, the beginning of the eyebrows, side of the eyes, under the eyes، the distance between the nose and upper lip, the chin, under the clavicle and armpit 7 times.  next they said positive words (I accept myself as I am) and again they hit every point 7 times. This technique goes on for 4 weeks and every week for three days. The people in the control group only receive normal medical care. Intervention 2: Control group: After informed consent and completing the questionnaires, participants in the control group will receive only routine medical care.</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 After completion of the study, if necessary, the encoded data will be published along with the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nilofar pasyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Namazi Square, the entrance to Namazi Hospital, Hazrat Fatemeh College of Nursing and Midwifery.</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119-71936</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>npasyar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nilofar pasyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Namazi Square, the entrance to Namazi Hospital, Hazrat Fatemeh College of Nursing and Midwifery.</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119-71936</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>Npasyar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with an 18 - year - old and more
at least 6 months since the dialysis started
Doing hemodialysis 2 to 4 times at week.
The ability to understand and speak persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of chronic mental illness known by a physician's diagnosis
A patient suffering from retinopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y84.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After Informed consent and completing the questions by the intervention group، in a short interview with the patient, it is clear that the situation has caused unhappiness، Then with an unpleasant concentration, a series of positive and negative words are introduced to the patient in order to comfort themselves by those words. In our first phase in the intervention group, we want patients to say the positive and negative tree times like, (I'm always nervous about being dependent on the dialysis device, but I accept myself as I am) and every time they says that،  with the top of the middle finger hit to the karate chop point in the other hand Gently 7 times ، so that the dominant hand might bend over the wrist. At the next stage they said negative words (I'm always nervous about being dependent on the dialysis device) and hit  to the meridian points Including: the top of head, the beginning of the eyebrows, side of the eyes, under the eyes، the distance between the nose and upper lip, the chin, under the clavicle and armpit 7 times.  next they said positive words (I accept myself as I am) and again they hit every point 7 times. This technique goes on for 4 weeks and every week for three days. The people in the control group only receive normal medical care.</i_keyword>
      <i_keyword>Control group: After informed consent and completing the questionnaires, participants in the control group will receive only routine medical care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety scores in Spielberger's state-trait anxiety questionnaire. Timepoint: Before the intervention and four weeks after an intervention (Emotional Freedom Techniques). Method of measurement: Spielberger state- trait anxiety inventory.</prim_outcome>
      <prim_outcome>Fatigue scores on the Multidimensional Fatigue Inventory. Timepoint: Before the intervention and four weeks after an intervention  (Emotional Freedom Techniques). Method of measurement: Multidimensional Fatigue Inventory.</prim_outcome>
      <prim_outcome>Physical and mental symptom burden score in dialysis Symptoms burden Index questionnaire. Timepoint: Before the intervention and four weeks after an intervention  (Emotional Freedom Techniques). Method of measurement: Dialysis Symptoms burden Index.</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>2024-02-04</approval_date>
        <contact_name>The Moral Committee of shiraz Medical science university</contact_name>
        <contact_address>Vice Chancellor for Research, 7th floor, Shiraz University of Medical Science, Zand st. shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
