<?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>IRCT20240205060909N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Spiritual self-care education after bone marrow transplantation</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of spiritual self-care education on anxiety and life expectancy of patients after bone marrow transplantation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75333</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After visiting the Bone Marrow Transplant(BMT) Clinic of Shariati Hospital, people who meet the entry criteria are selected and after necessary explanations and obtaining informed consent, they are randomly grouped into two control and intervention groups. The website https://www.sealedenvelope.com is used to generate the block random sequence and sealed opaque envelopes are used to hide the random allocation. Each of the generated random sequences is recorded on a card and the cards are placed in the letter envelopes. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. The lids of the letter envelopes are glued and placed in a box respectively. The participants open one of the envelopes and enter one of the groups based on it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients after bone marrow transplantation.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group consists of 30 people who are grouped into three groups of 10 people. Our intervention is the training of the spiritual self-care program, which is done by a spiritual care specialist. The duration of the intervention is 6 weeks in the form of 60-minute sessions .In the first session, the goal is to introduce and familiarize the members of the group and the leader to each other, in the second session, the goal is to improve and strengthen the relationship with God, and in the third session, to teach patience and its difference with tolerance. In the fourth session, the goal is to strengthen and connect with oneself and to achieve self-esteem. The fifth is strengthening communication with others and preparing people for the end of the sessions, and the sixth session is improving and strengthening communication with nature, and in each session, the patients do the tasks that have been said, including communication techniques, waiting, etc., and in the session They give feedback later.Before and after the intervention, the participants must answer two anxiety and life expectancy questionnaires. Intervention 2: The control group: includes 30 people who met the conditions for entering the study, but they were not taught the spiritual self-care program and only answered the anxiety and life expectancy questionnaire before and after the intervention. It should be noted that after At the end of the study, the file of all sessions is provided to the intervention group.</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:
Part of the data of the people participating in the study that is related to the outcome will be published

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and medical centers

Conditions:
Use with references
Compliance with ethical protocols

Where to obtain:
For the convenience of patients, they can contact the contact number of the responsible author.
09916669162 Zohre Shoorvazdi.

How to obtain:
From the time of sending the written request, she will have access to the data for a maximum of two weeks if the protocols are followed.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohre.Shoorvazdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Province, Tehran, N St, No. 18, Kargar, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439355975</zip>
        <telephone>+98 21 8801 6071</telephone>
        <email>shoorvazdizohre@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zohre.shoorvazdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Province, Tehran, N St, No. 18, Kargar, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955975</zip>
        <telephone>+98 21 8801 6071</telephone>
        <email>nrzohre.shoorvazdi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receive a bone marrow transplant
Age between 18-64 years
Absence of acute bone marrow transplant complications
Consent to participate in the study
Muslim and Shia religion
Ability to speak, read and write in Persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>64 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having known anxiety disorder or mental illness
Participation in spiritual care courses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group consists of 30 people who are grouped into three groups of 10 people. Our intervention is the training of the spiritual self-care program, which is done by a spiritual care specialist. The duration of the intervention is 6 weeks in the form of 60-minute sessions .In the first session, the goal is to introduce and familiarize the members of the group and the leader to each other, in the second session, the goal is to improve and strengthen the relationship with God, and in the third session, to teach patience and its difference with tolerance. In the fourth session, the goal is to strengthen and connect with oneself and to achieve self-esteem. The fifth is strengthening communication with others and preparing people for the end of the sessions, and the sixth session is improving and strengthening communication with nature, and in each session, the patients do the tasks that have been said, including communication techniques, waiting, etc., and in the session They give feedback later.Before and after the intervention, the participants must answer two anxiety and life expectancy questionnaires</i_keyword>
      <i_keyword>The control group: includes 30 people who met the conditions for entering the study, but they were not taught the spiritual self-care program and only answered the anxiety and life expectancy questionnaire before and after the intervention. It should be noted that after At the end of the study, the file of all sessions is provided to the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ََAnxiety. Timepoint: Before the intervention, four weeks after the intervention. Method of measurement: State-Trait Anxiety Inventory (STAI).</prim_outcome>
      <prim_outcome>Life expectancy. Timepoint: Before the intervention, four weeks after the intervention. Method of measurement: Miller hope scale (MHS).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-12</approval_date>
        <contact_name>Research Institute of Oncology, Hematology and Tuberculosis Therapy, Tehran University of Medical Sc</contact_name>
        <contact_address>North Kargar St., Jalal Al Ahmad Street, in front of Faculty of Economics, Dr. Shariati Research and Treatment Center, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
