<?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>IRCT20181126041762N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-16</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of foot massage on postoperative pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of reflexology massage of aromatic and non-aromatic oil on the pain of patients after coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37626</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly assigned into three groups: massage therapy and massage with non-aromatic oil and non-oil control group. Each block is executed in a variety of possible states of the letters AABBCC and then by random selection for each block to complete the sample size. In the study, they are assigned to each of the three groups that are collected in collaboration with the head nurse. We will record the type of intervention with a four-digit code in a suitable position and refer the eligible patients from Nos. 1 to 108 to the envelope and the four-digit pre-prepared intervention in the appropriate container inside the envelope. The evaluator is collecting the data in the form of data collection, with the four-digit code included, but not from the intervention group, Blinding description: Data will be collected in order to blind this study in collaboration with the head nurse. We will record the type of intervention with a four-digit code in a suitable position and refer the eligible patients from Nos. 1 to 108 to the envelope and the four-digit pre-prepared intervention in the appropriate container inside the envelope. The evaluator is collecting data in the form of data collection, with the four-digit code mentioned, but not from the intervention group. The masseur and pain assessor are separate. Also, the massage interval to the next assessment increases the intervention for 30 minutes, to reduce the amount of lavender oil aroma, and after 30 minutes the amount of pain is assessed using a visual analogue scale. This procedure is performed at 12 o'clock And the 24th post-operative is also repeated. On this basis, the evaluator is not aware of the status of the groups. The masseur will also provide intervention for separate and unconnected patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: After 6 hours of operation, and after the advancement of the patient, the patient is asked to examine the patient. Prior to massaging, the researcher will examine the pain level using a standardized-neurological scale. The researcher then traces the curtains around the patient and minimizes the external sounds. The researcher next to the patient was sitting on the chair and sitting on the left leg of the feet using almond oil for 1 minute, and for 20 minutes, in addition to relaxing exercises on the foot, massage of the foot of the foot is done on the entire left foot. Then the amount of pain again This intervention is in hours 12 and 24 hours after surgery will be repeated. Intervention 2: Second intervention group: After 6 hours of operation, and after the advancement of the patient, the patient is asked for treatment. Before applying for massage, the pain is assessed by the researcher using the standard-reporting scale. Next, the researcher draws the curtains around the patient and minimizes the external sounds. Then the researcher next to the patient is seated on the chair and the left leg of the patient using a mixture of almond oil and lavender oil for 1 minute, and for 20 minutes, in addition to relaxing exercises on the foot, massaging of the foot of the foot is done on the entire left foot of the foot. Then the amount The pain is re-examined This intervention at 12 and 24 hours after surgery will be repeated. Intervention 3: Control group: After 6 hours of operation, and after the advancement of the patient, the patient is asked for treatment. Before exercising, the pain is assessed by the researcher using the standard-obsessive scale. The researcher then draws the curtains around the patient and minimizes the external sounds. The researcher next to the patient was sitting on the sitting chair and the left leg of the patient without using any natural products, for 20 minutes, dry massage, and relaxing exercises on the foot, massage of the foot of the foot on the entire left foot of the leg. Then the amount of pain again This intervention is at 12 o'clock Will be repeated 24 hours after surgery.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samere Rasouli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Forest Avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4464155343</zip>
        <telephone>+98 13 3467 1009</telephone>
        <email>samereh.rasoli928@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samere Rasouli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Forest Avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4464155343</zip>
        <telephone>+98 13 3467 1009</telephone>
        <email>samereh.rasoli928@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complete vigilance
Patient Satisfaction to Participate in the Study
Heart surgery for the first time
Elective Heart Surgery
No use of nerve and respiratory drugs
Hemodynamic stability
Having a sense of smell and no hearing loss or vision</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate and continue cooperation in the study
Not having full vigilance
Lack of sense of smell, hearing loss or an inability to communicate
Intooth more than 6 hours later
The history of chronic pain
Having a fracture, an infective wound on the left foot
Drug Addiction
Need to re-intubate or re-arrange the heart</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: After 6 hours of operation, and after the advancement of the patient, the patient is asked to examine the patient. Prior to massaging, the researcher will examine the pain level using a standardized-neurological scale. The researcher then traces the curtains around the patient and minimizes the external sounds. The researcher next to the patient was sitting on the chair and sitting on the left leg of the feet using almond oil for 1 minute, and for 20 minutes, in addition to relaxing exercises on the foot, massage of the foot of the foot is done on the entire left foot. Then the amount of pain again This intervention is in hours 12 and 24 hours after surgery will be repeated.</i_keyword>
      <i_keyword>Second intervention group: After 6 hours of operation, and after the advancement of the patient, the patient is asked for treatment. Before applying for massage, the pain is assessed by the researcher using the standard-reporting scale. Next, the researcher draws the curtains around the patient and minimizes the external sounds. Then the researcher next to the patient is seated on the chair and the left leg of the patient using a mixture of almond oil and lavender oil for 1 minute, and for 20 minutes, in addition to relaxing exercises on the foot, massaging of the foot of the foot is done on the entire left foot of the foot. Then the amount The pain is re-examined This intervention at 12 and 24 hours after surgery will be repeated.</i_keyword>
      <i_keyword>Control group: After 6 hours of operation, and after the advancement of the patient, the patient is asked for treatment. Before exercising, the pain is assessed by the researcher using the standard-obsessive scale. The researcher then draws the curtains around the patient and minimizes the external sounds. The researcher next to the patient was sitting on the sitting chair and the left leg of the patient without using any natural products, for 20 minutes, dry massage, and relaxing exercises on the foot, massage of the foot of the foot on the entire left foot of the leg. Then the amount of pain again This intervention is at 12 o'clock Will be repeated 24 hours after surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Measurement of pain before and after the intervention and after the intervention at 6,12 and 24 hours after surgery. Method of measurement: Visual Analog Scale.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-01</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Field Teacher, Student Research Assistant Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
