<?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>IRCT2015080623525N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-28</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot massage on agitation in patients undergoing electroconvulsive therapy</public_title>
      <acronym>-</acronym>
      <scientific_title>The effect of foot  reflexology on anxiety in patients undergoing electroconvulsive therapy and complications after it, a clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20041</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety,Amnesia and pain.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: Massaging the soles of the feet will be done as three times a week by the researcher and female assistant researcher in the morning shifts and when will not interfere with the round section (visit time, occupational therapy). reflexology mesaage will be done 3 times a week, each session lats 40 minutes for 1 week, and for each foot massage is done for 20 minutes to 10 minutes for foot basic message, and its 10 minutes of massage areas is related to anxiety and relaxation. Allocated patients in the intervention group, reflexology using with olive oil will be carried out without the using of gloves. Intervention 2: Only the patient's feet will be anointed with olive oil.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Introduction: Electroconvulsive therapy in the psychiatric disorders, due to complications such as severe anxiety caused by invasion, yet has failed to achieve its real position in the field of psychiatry. With regard to the restriction of the use of medicines for anxiety management, a study was conducted in these patients with a purpose to evaluate the effect of reflexology on reducing anxiety and complication after it in patients undergoing ECT.&lt;br /&gt;&#13;
Methods and materials: The present study was performed as a clinical trial with 68 admitted patients receiving ECT that were randomly assigned into control (n = 34) and intervention groups (n = 34). In the test group, the intervention was measured during three 20-min sessions, and in the control group, the patient leg was massaged for 1 minute using olive oil. The amnesia score of patients was equally measured and compared 30 minutes after ECT at the end of each session by using a (GALVESTON- ORIENTATION-AMNESIA-TEST) questionnaire.The anxiety of patients was measured once before the intervention (reflexology) in both groups, and once again, after the ECT (after consciousness of the patient) at the end of each session, with Spielberger state-trait anxiety inventory (STAI), and pain of the patients was measured and compared using numeric pain scale at 15 min after electroconvulsive therapy at the end of each session in both groups. The data was analyzed by SPSS v.13 using chi-square tests, independent t-test, repeated measurement and Friedman test.&lt;br /&gt;&#13;
Findings: The results showed the significant effect of the group on amnesia, this means that people who received the intervention were collected over the entire study had a significantly higher score in comparison of control group for score of anamnesis (p=.02). Also, the results showed that at the end of the third session of reflexology, the mean score of state anxiety (s) in the intervention group was had significantly reduced compared to the control group (p</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>Saeed Alinezhad machiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, South Shariati Avenue, Nursing and Midvifery</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>saeed.alinezhad1991@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Namdar Areshtanab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, South Shariati Avenue,</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3470 6770</telephone>
        <email>namdarh@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: candidated for ECT by a psychiatrist؛ no history of  eclectroconvulsive therapy؛ males and females with age of 18 years and over؛  lack of foot problems such as ulceration and scarring؛ Desiring to participate in the study؛ Be alert and aware؛ Lack of drug addiction and non-drug treatment of sleep the night before eclectroconvulsive therapy؛ lack of an underlying medical condition (having diabetes, hypothyroidism, Hypethyroidism, electrolyte disorders, neuromuscular diseases)؛ lack of perceptional disorders and impaired reality testing (hallucinations and delusions)؛ the absence of anxiety disorder؛Inform the doctor about the procedure on the patients؛ getting consent from protector of patient؛ no acute problems vision due to interference by filling out the Visual Analog Scale for Pain (VAS Pain).&#13;
Exclusion criteria: Patients who for any reason do not have the desire to continue working؛ patients in the acute phase of psychosis (hallucinations and delusions)؛ absence of more than one session in the process of intervention</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: Massaging the soles of the feet will be done as three times a week by the researcher and female assistant researcher in the morning shifts and when will not interfere with the round section (visit time, occupational therapy). reflexology mesaage will be done 3 times a week, each session lats 40 minutes for 1 week, and for each foot massage is done for 20 minutes to 10 minutes for foot basic message, and its 10 minutes of massage areas is related to anxiety and relaxation. Allocated patients in the intervention group, reflexology using with olive oil will be carried out without the using of gloves.</i_keyword>
      <i_keyword>Only the patient's feet will be anointed with olive oil.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and immediately after the intervention. Method of measurement: Spilberger Questionnare.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>َAmnesia. Timepoint: Thirty minutes after electroconvulsive therapy. Method of measurement: Galveston- Orietation-Amnesia-Test.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Fifteen minutes after electroconvulsive therapy. Method of measurement: Numeric Pain 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>Vice chancellor for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-09</approval_date>
        <contact_name>Ethics committee of Tabriz university of medical sciences</contact_name>
        <contact_address>Golghasht Ave, Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
