<?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>IRCT20140422017387N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-24</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Emotional Freedom Technique on fatigue and pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Emotional Freedom Technique (EFT) on fatigue and pain in women with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, the samples were selected by simple method among patients with MS who had the criteria for entering the study with informed written consent and then by Minimization method using Mini-py software, they were randomly divided into two groups of test and sham with 1: 1 ratio, Blinding description: In this research, the participants will not aware of their intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the experimental group, the intervention of emotional freedom technique (EFT  ),for each patient individually is performed for 4 weeks at twice a week for 30 minutes.This technique has four steps, the first step is called "The setup phrase",that patient repeats 3 times "Even though I have pain (the name of the problem), I deeply and completely accept myself",and Concurrent researcher massages the sore spot point (point ST14 acupuncture). In the second step, the patient focusing on the problem, researcher taps 10 times on 13 acupuncture points including points (DU20, BL2, GB1, ST1, GV26, CV24, KD27, SP21, LU11, LI1, HT9, SI3 PC9) with pointed and middle fingertips. In the third step, the researcher taps on gamut point at the back of the hand (TH3 acupuncture point) and at the same time 9 brain stimulator actions involving( closing, opening the eyes, looking Go down and right, looking down and left, turning the eyes clockwise, and then opposing it, whispering a favorite song for 2 seconds, fast counting numbers from 1 to 5, muttering the desired song to For 2 seconds ) by the patient is performed and the fourth step is the second step repetition, Performing these 4 steps is called an eft round and these cycles were repeated for 30 minutes. Intervention 2: In this study, the sham group (placebo) will be the control group.The researcher, while tapping with the point and middle fingers on the false points including biparital, the outer margin of the chin, the sides, the vertex of the nails, the forearm, wants the patient who repeat set up  phrase and focussin the problem (like the test group), this procedure will also be performed for 30 minutes , 2 times in weeks within 4 weeks.</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 The results and data are still not fully understood.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib st,Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 7589</telephone>
        <email>nazari@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing Adult Health, School of Nursing and Midwifery, University of Medical Science.Hezar jerib st. Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73465</zip>
        <telephone>+98 31 3792 7589</telephone>
        <email>nazari@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria:Women with multiple sclerosis 18 to 50 years old at least 6 months of definite diagnosis of MS
Having fatigue severity score equal to or greater than 4 based on Fatigue severity scale(FSS)
Having a pain score at least 4 for at least 6 months based on the numerical rating scale of pain(NRS)
A score equal to or less than 4.5 on the Expanded Disability Status Scale (EDSS)
No other illness other than MS is approved by the physician and  medical records of the subject
Absence in the menstrual period.
Not Pregnancy
Non-use of other alternative and complementary methods in the last 6 months
Non-drug addiction and psychosis.
No harm and wound in the desired acupuncture points</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion Criteria:unwillingness to continue to collaborate in research
Use of other complementary therapies such as acupuncture, yoga, meditation during intervention
Absences for more than two consecutive sessions during the study
In case of pregnancy, recurrence of illness or hospitalization in hospital during intervention.
Added new analgesic drug to previous medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35-G37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Demyelinating diseases of the central nervous system</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: In the experimental group, the intervention of emotional freedom technique (EFT  ),for each patient individually is performed for 4 weeks at twice a week for 30 minutes.This technique has four steps, the first step is called "The setup phrase",that patient repeats 3 times "Even though I have pain (the name of the problem), I deeply and completely accept myself",and Concurrent researcher massages the sore spot point (point ST14 acupuncture). In the second step, the patient focusing on the problem, researcher taps 10 times on 13 acupuncture points including points (DU20, BL2, GB1, ST1, GV26, CV24, KD27, SP21, LU11, LI1, HT9, SI3 PC9) with pointed and middle fingertips. In the third step, the researcher taps on gamut point at the back of the hand (TH3 acupuncture point) and at the same time 9 brain stimulator actions involving( closing, opening the eyes, looking Go down and right, looking down and left, turning the eyes clockwise, and then opposing it, whispering a favorite song for 2 seconds, fast counting numbers from 1 to 5, muttering the desired song to For 2 seconds ) by the patient is performed and the fourth step is the second step repetition, Performing these 4 steps is called an eft round and these cycles were repeated for 30 minutes.</i_keyword>
      <i_keyword>In this study, the sham group (placebo) will be the control group.The researcher, while tapping with the point and middle fingers on the false points including biparital, the outer margin of the chin, the sides, the vertex of the nails, the forearm, wants the patient who repeat set up  phrase and focussin the problem (like the test group), this procedure will also be performed for 30 minutes , 2 times in weeks within 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The fatigue severity score based on Fatigue severity Scale (FSS). Timepoint: Before, immediately and four week after interventions. Method of measurement: Questionnaire of the fatigue severity score  for MS Patients(FSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain severity based on numerical ratting scale (NRS). Timepoint: Before, immediately and four week after interventions. Method of measurement: based on 10 numerical ratting scale (NRS).</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-30</approval_date>
        <contact_name>Ethics committee Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences.Hezar Jerib st. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
