<?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>IRCT20220405054421N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-12</date_registration>
      <primary_sponsor>Abadan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of plantar reflexology on dyspnea, fatigue and anxiety of patients with coronavirus in educational hospitals affilated to Abadan of medical sciences university in 1400-1401</public_title>
      <acronym>COVID- SARS</acronym>
      <scientific_title>The effect of plantar reflexology on dyspnea, fatigue and anxiety of patients with coronavirus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62786</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Eligible samples, after being selected from medical centers, based on the file number in a simple random method, will be assigned to the control and intervention groups. For concealment, we use allocation concealment that is related to used method for implementing execution of random sequence on study participants so that the assigned group not be known before the individual is assigned. using opaque envelopes, Sequentially numbered, sealed with random sequence in which record on a card and replace  into envelopes orderly. In order to maintain a random sequence, numbering on external surface of envelopes be done orderly. finally, the envelopes are glued and placed inside a box, respectively.Based on the order of entry of eligible participants, at the time of registration of participants, one of the envelopes of the letter is opened in order and the assigned group of that participant will be revealed, Blinding description: Both patients and researchers will be unaware of the patient's exposure. Since this study is multi center an encrypted computer file indicate that what every code means. Only if the person's health is endangered will that code be broken.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dyspnea, anxiety, fatigue, reflexology in related to corona virus disease.</hc_freetext>
      <i_freetext>Intervention group: Reflexology of the sole of the foot with sweet almond oil for 6 weeks, once a week, 30 minutes each time, 10 minutes of general massage of the sole of the foot and 5 minutes of massage of the lung areas in the sole of the foot.</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 parts of the article (including introduction, purpose, method, results and discussion and sources) will be available after completion and publication in a reputable journal. All data is potentially shareable after unidentified individuals

When:
The access period will start 6 months after the results are published.

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
Applicants can access some of the required documents if they do research and introduce their work

Where to obtain:
Applicants will receive the documentation of the article after the publication of the article through google scholar website or  pub med

How to obtain:
If the applicant receives the article file after publication from a particular journal, according to the rules of the journal, she must go through the necessary processes to access the article, such as payment, membership in the website, obtaining a username and password.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Motahareh Musavi Ghahfarokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>airport square, next to international airport, deputy of educational, Abadan university of medical sciences</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6313833177</zip>
        <telephone>+98 61 5326 5357</telephone>
        <email>motahare_musavi_ghahfarokhi@yahoo.com</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>motahareh musavi ghahfarokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>airport square, next to international airport, deputy of educational, Abadan university of medical sciences</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6313833177</zip>
        <telephone>+98 61 5326 5357</telephone>
        <email>motahare_musavi_ghahfarokhi@yahoo.com</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having relative independence in performing daily life activities
having appropriate level of consciousness
Corona virus with moderate to severe lung involvement
willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>decreasing level of consciousness
having problems in feet include circulation disorders
paraesthesia
tissue ulcers
amputation
pregnant women
psychiatric patients
sever hepatic, cardiac and renal patients
applying complementary and alternative therapies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>reflexolog</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dyspnea, anxiety, fatigue, reflexology, COVID 19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Reflexology of the sole of the foot with sweet almond oil for 6 weeks, once a week, 30 minutes each time, 10 minutes of general massage of the sole of the foot and 5 minutes of massage of the lung areas in the sole of the foot</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of fatigue, dyspnea and anxiety in patients with Corona virus. Timepoint: Evaluation of  fatigue, dyspnea and anxiety in COVID patients after 6 weeks. Method of measurement: Fatigue Sever Scale, Burge dyspnea scale, Spielberger overt and covert anxiety questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The rate of dyspnea, fatigue and anxiety in patients with coronavirus. Timepoint: dyspnea, fatigue and anxiety in patients with coronavirus after 6 weeks. Method of measurement: Spielberger Manifest and Visible Anxiety Inventory, Fatigue Intensity Scale and Burge dyspnea.</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>Abadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-23</approval_date>
        <contact_name>Ethics committee of Abadan university of medical sciences</contact_name>
        <contact_address>airport square, next to international airport, Deputy of educational, Abadan university of medical sciences, Abadan, Iran Abadan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
