<?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>IRCT20180220038805N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-01</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effectiveness of transcutaneous electrical nerve stimulation and foot reflexology on pain and fatigue in patients after Coronary artery bypass graft surgery"</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of transcutaneous electrical nerve stimulation and foot reflexology on pain and fatigue in patients after Coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30023</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Assignment of samples will be done by the method of permutation blocks، In this method, the number one to the Massage intervention group، The number two will be allocated to the Tens group and the three to the control group. In this way, the blocks of six are formed and all the necessary permutations are listed Then one will be chosen from among them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with coronary artery bypass surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:First: In this group, the foot massage will be performed, this intervention will be performed once for 20 minutes per foot for 10 minutes. Intervention by the researcher and for the men by the partner's colleague, both of whom have already been fully trained by the relevant specialist. Performing massage with a reflexology stick, called a stick, will be done. The styx, a standard device with soft, trendy feet used to massage the soles of the foot, is a tool made in China and has been used to do it since ancient times. Reflexology has been used. Before the start and during the work, the conditions of the room, the conditions of the research unit and the conditions of the researcher will be taken into account: the room temperature will be kept to a balanced level. Intervention 2: Intervention group: Second: In the second group, the Tens model med450, which is made by Iran, will be used. Due to the presence of electrodes and the possibility of patient's fear, it will be fully explained to the patient, which will have no complications. The electrodes are connected around the wound area and run at equal frequencies for all patients and equal flow intensity during 15 minutes of intervention. This will be done by the researcher himself and for everyone with a device. Intervention 3: Control group: Third: No intervention is possible.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The total potential data after unidentifiable individuals can be shared.

When:
Since 1397

To whom:
All people

Conditions:
To read and mention the source

Where to obtain:
Taghizades95@medsab.ac.ir

How to obtain:
Apply to an email to be answered within 3 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences، Tohid Township</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51 4401 3001</telephone>
        <email>rad.mojtaba89@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soghra Taghizadeh Mehneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences، Tohid Township</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 44013001</telephone>
        <email>Taghizades95@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having satisfaction for the study
Patients who are fully conscious of the full leg of their legs
Patients have the ability to read and write
Ability to understand and speak Persian
Patients with an allergy to gel electrode
Having age between 30 and 80</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity to touch and massage
Sensory disturbances on the foot of the leg
History of using palpable reflexes or skin electrical stimulation
Psychological and cognitive disorders
Having a pacemaker heart
Bradycardia (less than 60 beats per minute) and hypotension (blood pressure less than 90 mm Hg)
Drug addiction, alcoholism and alcoholism
The history of diabetes over 4 years
Having blood disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I79*</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of arteries, arterioles and capillaries in diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:First: In this group, the foot massage will be performed, this intervention will be performed once for 20 minutes per foot for 10 minutes. Intervention by the researcher and for the men by the partner's colleague, both of whom have already been fully trained by the relevant specialist. Performing massage with a reflexology stick, called a stick, will be done. The styx, a standard device with soft, trendy feet used to massage the soles of the foot, is a tool made in China and has been used to do it since ancient times. Reflexology has been used. Before the start and during the work, the conditions of the room, the conditions of the research unit and the conditions of the researcher will be taken into account: the room temperature will be kept to a balanced level.</i_keyword>
      <i_keyword>Intervention group: Second: In the second group, the Tens model med450, which is made by Iran, will be used. Due to the presence of electrodes and the possibility of patient's fear, it will be fully explained to the patient, which will have no complications. The electrodes are connected around the wound area and run at equal frequencies for all patients and equal flow intensity during 15 minutes of intervention. This will be done by the researcher himself and for everyone with a device.</i_keyword>
      <i_keyword>Control group: Third: No intervention is possible</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue is an unpleasant sensation experienced by patients after coronary artery bypass graft surgery and measured by Visual Analogue scale. Timepoint: Before the intervention, immediately after intervention and half an hour later intervention. Method of measurement: Using Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The pain is experienced by patients after coronary artery bypass surgery and measured by Visual Analogue Scale  scale. Timepoint: Before the intervention, immediately after intervention and half an hour later intervention. Method of measurement: Using Visual Analogue 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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-18</approval_date>
        <contact_name>Ethics committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences، Tohid Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
