<?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>IRCT2015052916564N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-21</date_registration>
      <primary_sponsor>Urmia University of Medical Sciences, Vice chancellor for reasearch</primary_sponsor>
      <public_title>Cognitive status of patients treated with Electroconvulsive Therapy (ECT)</public_title>
      <acronym>Electroconvulsive Therapy (ECT)</acronym>
      <scientific_title>Study The effect of supportive_ educational nursing interventions  on cognitive status of patients treated with Electroconvulsive Therapy (ECT)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15476</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Schizophrenia. Condition 2: Major depression. Condition 3: Bipolar mood disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention consists of two parts: First part of the intervention consists of patient-education by the researcher who  has experience as psychiatric nurse. This part will done after determining the educational needs of the patient and according to previous information and the level of education. Educative intervention will be 30 minutes sessions which will be face-to-face and individually performed in the psychiatric-exam room located within the psychiatric wards. Material presented in this program; include a brief description on the electro convulsive therapy, introduction to its application, the beneficial effects of treatment, methods and preparations, complications, drugs and nursing care before and after ECT. The second part of intervention will be supportive in nature. It will begin just before the each ECT session and will continue after 2 hours of ECT administration. These interventions include effective communication with the patient and supportive care in three dimensions: Information, emotional and physical, including providing information to patients, Responding to questions asked by patients before, During and after the sessions, Explaining the reasons for using this method in patients, explaining the responsibilities of treatment group members, encouraging to express feelings, assessing negative beliefs and fears of patients. Stablishing mutual trust, as well as physical care of these patients due to patient safety in terms of damage due to cognitive impairment after ECT,encouraging patient to do physical activity in order to reduce physical pain  between sessions. Intervention 2: Control group: Control group will receive education routine and usual care by nurses  including: NPO, Voiding , Leaving  jewelry and metals.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sarieh Sheikhmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>11 Km Road seru, Campus Nazlu, University of Medical Sciences, Nursing and Midwifery Faculty</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>575611-5111</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>www.sheikhmohammadi_s@yahoo.com</email>
        <affiliation>Urmia University of Medical Sciences, Nursing and Midwifery Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Moloud Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>11 Km Road seru, Campus Nazlu, University of Medical Sciences, Nursing and Midwifery Faculty</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>575611-5111</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>mradfar1343@gmail.com; radfar.m@umsu.ac.ir</email>
        <affiliation>Urmia University of Medical Sciences, Nursing and Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age 18-60 year; lack of physical disease leads to cognitive impairment; lack of chronic disease and disability; and negative symptoms of schizophrenia, associated with their impaired reality-testing ability.&#13;
 Exclusion criteria: Patients who are receiving less than 6 sessions of ECT; patients who receive more than one attempt of electrical shock treatment in one day in order to induce effective convulsive response.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
      <hc_code>F32.3</hc_code>
      <hc_code>F31.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
      <hc_keyword>Severe depressive episode with psychotic symptoms</hc_keyword>
      <hc_keyword>Bipolar affective disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention consists of two parts: First part of the intervention consists of patient-education by the researcher who  has experience as psychiatric nurse. This part will done after determining the educational needs of the patient and according to previous information and the level of education. Educative intervention will be 30 minutes sessions which will be face-to-face and individually performed in the psychiatric-exam room located within the psychiatric wards. Material presented in this program; include a brief description on the electro convulsive therapy, introduction to its application, the beneficial effects of treatment, methods and preparations, complications, drugs and nursing care before and after ECT. The second part of intervention will be supportive in nature. It will begin just before the each ECT session and will continue after 2 hours of ECT administration. These interventions include effective communication with the patient and supportive care in three dimensions: Information, emotional and physical, including providing information to patients, Responding to questions asked by patients before, During and after the sessions, Explaining the reasons for using this method in patients, explaining the responsibilities of treatment group members, encouraging to express feelings, assessing negative beliefs and fears of patients. Stablishing mutual trust, as well as physical care of these patients due to patient safety in terms of damage due to cognitive impairment after ECT,encouraging patient to do physical activity in order to reduce physical pain  between sessions.</i_keyword>
      <i_keyword>Control group: Control group will receive education routine and usual care by nurses  including: NPO, Voiding , Leaving  jewelry and metals</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognative status. Timepoint: Within the period of 15, 30, 60 minutes and 24 hours after the first, third and sixth Electroconvulsive Therapy. Method of measurement: Mini Mental Status Examination.</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>Urmia University of Medical Sciences, Vice chancellor for reasearch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-28</approval_date>
        <contact_name>Urmia University of Medical Sciences</contact_name>
        <contact_address>Urjance alley, Resalat Blvd, Urmia Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
