<?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>IRCT20201101049219N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-10</date_registration>
      <primary_sponsor>Janbazan Medical and Engineering Research Center (JMERC)</primary_sponsor>
      <public_title>Effects of spiritual practice on recovery of Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual practice along routine medical care on the recovery of patients hospitalized with Covid-19: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients were first divided into two groups: less than 60 years and 60 years and more. Then, in order to assign the patient to the intervention or control group in this study, the method of randomization blocks with a volume of 4 was used. These blocks were prepared in R software using the blockrand package. If there is an admission order in the file of each patient, the patient who accepts the conditions for admission to the study, if the patient is 60 years and older, enters the study using randomly defined blocks of volume 4 for people 60 years and older And if he is less than 60 years old, he enters the study using other randomly defined blocks for people under 60 years old. The patient is assigned to the intervention or comparison group in the same way according to the random table, and the next individuals are included in the study in the same way according to the random table. There is no concealment in this study, Blinding description: In this study, the patient and the researcher are in the intervention and comparison group, while the other members, including the clinical caregiver, outcome assessor, and data analyzer, do not know which patients are in which study group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: In this study, participants are divided into two groups of intervention and control. The intervention group, in addition to the usual treatments prescribed by doctors in the hospital, receives a spiritual-religious care package that includes a seven-day period and three times a day reciting dhikr or Allah and Surah Hamad. Thus, the patient who has entered the intervention group for seven days should recite Surah Al-Hamd 3 times and Zikr Ya Allah 66 times every morning, noon and night. In order to remind, a table has been prepared that the patient enters in the table every time he recites the dhikr. Saying dhikrs is controlled and reminded daily by the researcher who is present in the hospital. The intervention is non-invasive and does not interfere with other treatment processes. Intervention 2: Control group: Control group: Control group: Patients in the control group receive only the usual treatments prescribed by doctors in the hospital.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Batool Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>N0 17, Farokh st. Mogadase Ardabili, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985946563</zip>
        <telephone>+98 21 2241 5397</telephone>
        <email>mousavi.b@gmail.com</email>
        <affiliation>Janbazan Medical and Engineering Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Batool Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, Farokh St., Moghadas Ardebili St.,Yaman St., Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985946563</zip>
        <telephone>+98 21 2241 5397</telephone>
        <email>mousavi.b@gmail.com</email>
        <affiliation>Janbazan Medical Engineering Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with positive Covid-19  test report.
Patients hospitalized due to Covid-19.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any clinical condition that affects a person's ability to participate in a spiritual self-care program, such as diagnosed psychological problems.
Any clinical condition that may limit the patient spiritual practice  such as drowsiness or decrease level of consciousness.
ICU addmision
Teenagers and children
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07. 1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>U07.1:Confirmed cases of COVID-19 with positive or presumptive-positive test results</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, participants are divided into two groups of intervention and control. The intervention group, in addition to the usual treatments prescribed by doctors in the hospital, receives a spiritual-religious care package that includes a seven-day period and three times a day reciting dhikr or Allah and Surah Hamad. Thus, the patient who has entered the intervention group for seven days should recite Surah Al-Hamd 3 times and Zikr Ya Allah 66 times every morning, noon and night. In order to remind, a table has been prepared that the patient enters in the table every time he recites the dhikr. Saying dhikrs is controlled and reminded daily by the researcher who is present in the hospital. The intervention is non-invasive and does not interfere with other treatment processes.</i_keyword>
      <i_keyword>Control group: Control group: Control group: Patients in the control group receive only the usual treatments prescribed by doctors in the hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>According to the hospital stress and anxiety questionnaire, the score of hospital anxiety will be measured in patients with Covid-19 before and after the intervention. At the beginning of the study, a hospital anxiety questionnaire will be completed for all participants. Then the intervention will be done. After the intervention on the seventh day, the hospital anxiety questionnaire will be completed for the patients. Timepoint: Hospital anxiety will be measured at the beginning of the study before the intervention and on the seventh day. Method of measurement: Hospital Anxiety and Depression 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>مرکز تحقیقات مهندسی و علوم پزشکی جانبازان</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-12</approval_date>
        <contact_name>Research ethics committee veterans and martyrs affair foundation (VMAF)</contact_name>
        <contact_address>No. 17, Farokh St., Moghadas Ardebili St.,Yaman St., Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
