<?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>IRCT20201003048905N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-07</date_registration>
      <primary_sponsor>Larestan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of spiritual care based on Ghalbe Salim on anxiety related to COVID-19 (corona phobia)</public_title>
      <acronym></acronym>
      <scientific_title>Effect of spiritual care based on Ghalbe Salim on anxiety related to COVID-19 (corona phobia) in working women of Larestan offices in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51394</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The researcher extracts the list of government offices in Larestan by referring to Larestan city governor's office and writes the name of each office on a piece of paper. In the next step, the papers are entered into the envelopes and 7 envelopes are selected through simple random sampling. Therefore, 7departments are selected for sampling up to this stage. In the next step, the researcher provides ethical and scientific permission to the city governor to write letters to selected departments.
Researcher explains the goals of the plan as well as the criteria for entering and leaving the study and requests from selected departments to introduce 4 working women who wants to participate in the present study through the contact number.
Individuals are divided into 7 blocks of 4 by contacting the researcher and randomly assigning random blocks.
Therefore, in each block, 2 people are assigned to the intervention group and 2 people to the control group
Finally, 14 women are in the intervention group and 14 women are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anxiety related to corona disease (coronaphobia).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : The program of spiritual intervention based on Ghalbe Salim, which is based on Islamic verses and hadiths and approved by religious experts, is developed in four areas and includes the following:                                            A) Communication with God                                                                                       B) Communication wit yourself.                                                                                     C) Communication with others.                                                                                  D) Relationship with nature and environment.                                                        The program was presented in 6 sessions as follows:                                    Session 1: Initial evaluation, welcome, explanation of group rules, statement of goals and structure of meetings, initial evaluation feedback, program implementation                                                                                                    Session 2: Implement the program to provide solutions to strengthen the relationship with God.                                                                                          Session 3: Implement the program to provide solutions to strengthen self-communication.                                                                                                Sessions 4 and 5: Implement the program to provide solutions to strengthen relationships with others.                                                                                   Session 6: Presenting solutions to strengthen the relationship with the environment and nature and summarizing the previous sessions. Intervention 2: The "Control group" will not receive 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:
It can be shared by unidentifiable participants.

When:
Access begins a year after the publication of results

To whom:
People who are working in the academic and scientific institutions

Conditions:
it needs the agreement of Larestan University of Medical Sciences

Where to obtain:
zohreh Faramarzian, Instructor, Larestan University of Medical Sciences,            Email: zohreh.faramarzian@gmail.com
Contact Phone:00987152245009

How to obtain:
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Faramarzian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars Province, Larestan, New City, Dr. Dadman Highway, Next to Imam Reza Hospital, Hazrat Zeinab School of Nursing and Midwifery, Teacher's Office</address>
        <city>Larestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431895639</zip>
        <telephone>+98 71 5224 7110</telephone>
        <email>zohreh.faramarzian@gmail.com</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Faramarzian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars Province, Larestan, New City, Dr. Dadman Highway, Next to Imam Reza Hospital, Hazrat Zeinab School of Nursing and Midwifery, Teacher's Office</address>
        <city>Larestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431895639</zip>
        <telephone>+98 71 5224 7110</telephone>
        <email>zohreh.faramarzian@gmail.com</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Do not have acute family problems.
Have an interest and desire to participate in meetings.
Have no history of diagnosed mental illness (depression, violence, etc.).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Withdrawal from continuing cooperation during the study
Absence from more than one session of interventions
Failure to perform assigned tasks in more than one session</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group : The program of spiritual intervention based on Ghalbe Salim, which is based on Islamic verses and hadiths and approved by religious experts, is developed in four areas and includes the following:                                            A) Communication with God                                                                                       B) Communication wit yourself.                                                                                     C) Communication with others.                                                                                  D) Relationship with nature and environment.                                                        The program was presented in 6 sessions as follows:                                    Session 1: Initial evaluation, welcome, explanation of group rules, statement of goals and structure of meetings, initial evaluation feedback, program implementation                                                                                                    Session 2: Implement the program to provide solutions to strengthen the relationship with God.                                                                                          Session 3: Implement the program to provide solutions to strengthen self-communication.                                                                                                Sessions 4 and 5: Implement the program to provide solutions to strengthen relationships with others.                                                                                   Session 6: Presenting solutions to strengthen the relationship with the environment and nature and summarizing the previous sessions</i_keyword>
      <i_keyword>The "Control group" will not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety related to COVID-19 ( corona phobia ). Timepoint: At the beginning of the study and after the study. Method of measurement: Corona Anxiety Inventory.</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>Larestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-27</approval_date>
        <contact_name>Ethics Committee of Larestan University of Medical Sciences</contact_name>
        <contact_address>Fars, Larestan, Shahr-e Jadid, North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar larestan Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
