<?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>IRCT20080825001083N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-29</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology on anxiety and physiological parameters in patient under coronary artery bypass graft</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on anxiety and physiological parameters in patient under coronary artery bypass graft surgery referred to Dr.Heshmat educational and remedial center in Rasht,  2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48122</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: All eligible individuals will be divided into three groups of foot reflexology massage, routine massage, and control using block-randomized sized six-block blocking. In order to produce the randomization list, the 2019 online randomization service (the Sealed Envelope Ltd) was used: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: In order to blind the present study, the double-blind method was used. Thus, the analyst and the person allocating the samples (to three groups A, B and C) do not know the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary Artery Bypass Graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (A): Foot Reflexology massage. Before the massage, the researcher first washes his hands with warm water and smears them with sweet almond oil. He then massages the entire sole of the foot with special attention to the important reflection points of the sole of the foot. This intervention is performed for each leg for 15 minutes. First the right leg and then the left leg, which takes a total of 30 minutes. 10 minutes after the intervention, the consequences of the intervention (anxiety level and physiological parameters) are recorded. Intervention 2: Intervention group (B) or placebo group: Heel massage is performed superficially in patients without any pressure. 10 minutes after the intervention, the consequences of the intervention (anxiety level and physiological parameters) are recorded. Intervention 3: Control group (C):  On the third day after coronary artery graft and after transfer to the surgical ward, the level of anxiety and physiological parameters are measured, without any intervention.</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:
All study data can be shared after the samples are not identifiable.

When:
Immediately after the publication of the study results

To whom:
Data will be available to researchers working in academic and scientific institutions as well as health system managers.

Conditions:
Send a request to the corresponding author's email address for accessing the study data.

Where to obtain:
Corresponding author's email, Maji Pourshaikhian: pourshaikhian_m@yahoo.com

How to obtain:
Up to one week after sending the request to the email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Pourshaikhian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-76702</zip>
        <telephone>+98 13 3360 5768</telephone>
        <email>pourshaikhian_m@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Pourshaikhian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-47002</zip>
        <telephone>+98 13 3360 5768</telephone>
        <email>pourshaikhian_m@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient satisfaction to participate in the study
Candidate of non-emergency open heart surgery
Full awareness
Having a healthy limb (especially the soles of the feet)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No history of open heart surgery
No history of mental health problems, such as depression, according to medical history reports
No heart pacemaker
No alcohol or drug abuse
No history of chronic pain
Lack of previous history of reflexology
Lack of visual and auditory disorders
Do not take analgesic or sedatives for 3 h. before the intervention
No history of mitral valve replacement or regurgitation
Absence of the disorder during open heart surgery or recovery or hospitalization that has also affected the patient's anxiety
Lack of a history of various psychological changes that have a significant impact on the results of anxiety levels in the patient.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischemic Heart Disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (A): Foot Reflexology massage. Before the massage, the researcher first washes his hands with warm water and smears them with sweet almond oil. He then massages the entire sole of the foot with special attention to the important reflection points of the sole of the foot. This intervention is performed for each leg for 15 minutes. First the right leg and then the left leg, which takes a total of 30 minutes. 10 minutes after the intervention, the consequences of the intervention (anxiety level and physiological parameters) are recorded.</i_keyword>
      <i_keyword>Intervention group (B) or placebo group: Heel massage is performed superficially in patients without any pressure. 10 minutes after the intervention, the consequences of the intervention (anxiety level and physiological parameters) are recorded.</i_keyword>
      <i_keyword>Control group (C):  On the third day after coronary artery graft and after transfer to the surgical ward, the level of anxiety and physiological parameters are measured, without any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety level in Spielberger's questionnaire. Timepoint: At the beginning of the study (before the intervention) and 10 minutes after the foot reflexology massage. Method of measurement: Spielberger's questionnaire.</prim_outcome>
      <prim_outcome>Physiological parameters (systolic, diastolic blood pressure, heart rate, respiration rate and arterial oxygen saturation percentage). Timepoint: Measurement of physiological parameters at the beginning of the study (before the intervention) and 10 minutes after the reflex floor massage. Method of measurement: Monitoring system of vital signs made in Iran and Sazegar Gostar Company, VISTA model.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-06</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Opposite to 17 Shahrivar Hospital, Sayadati St., Namjoo St. Tel: 33336394 Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
