<?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>IRCT20200610047721N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-23</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Mindfulness-Based Stress Reducing Intervention on the Rate of Chronic Sorrow and Coping Behaviors</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Mindfulness-Based Stress Reducing Intervention on the Rate of Chronic Sorrow and Coping Behaviors in Mothers of Children with Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49625</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sample selection is done in such a way that all eligible samples are listed, then each of them is given a number that was randomly derived from the table of random numbers. There is no special order in writing these numbers. Next, the required number of samples is randomly selected from the numbers by drawing numbers. In placing people in the control and intervention groups, the block randomization method is used, in which 16 blocks of size 5 are selected and then patients are divided into two groups of 40 people as control and intervention groups based on the sequence of numbers created from block randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Leukemia. Condition 2: Brain tumors. Condition 3: Bone tumor. Condition 4: Wilms tumor. Condition 5: lymphoma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The purpose of the intervention in this study is to hold four sessions with the content of stress reduction based on mindfulness for mothers. The content of the sessions is the first session including introduction, expression of feelings and thoughts, body scan meditation, the second session includes body scan exercise, Three-minute breathing, the third session includes repeating the previous sessions and doing yoga movements. Finally, in the fourth session, the exercises will be reviewed and after completing the sessions, the questionnaires will be completed again. The sessions will be held once a week for a period of 45-120 minutes. Intervention 2: Control group: in the control group, mothers will not participate in mindfulness-based stress reduction sessions and will only complete the Coping Health Inventory for Parents (CHIP)and Kendall Chronic Sorrow Instrument Questionnaire.</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:
Questionnaire information and only part of the main outcome information

When:
six months

To whom:
Nursing students and nurses

Conditions:
Use in related research and similar to research title

Where to obtain:
Contact with Mahsa Moslem via email: mahsa.moslem20n@gmail.com

How to obtain:
Data will be available up to ten days after receiving the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Moslem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>sbnmf@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Moslem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>sbnmf@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be over 20 years old
Have a diagnosis of pediatric cancer by a oncologist doctor with a definite record in the patient's file
Mothers are aware of the diagnosis of their child's cancer.
Being the biological mother of the child.
The child's cancer is in the extinction stage.
At least 6 months have passed since the diagnosis of child cancer.
Being literate, have the ability to speak Persian.
Being physically and mentally able to answer questions and communicate.
Have consent to participate in the study.
Have the desire and ability to participate in face-to-face meetings.
Have access to mobile phones and familiarity with Mobogram or Talagram software.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother or first-degree relatives (except the child) have cancer.
The mother has cognitive, speech, or hearing problems.
Have a mental illness or anxiety disorder based on the child's records.
Have a degree (being educated) in psychology and medical sciences.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91.0</hc_code>
      <hc_code>C71</hc_code>
      <hc_code>C40</hc_code>
      <hc_code>C64</hc_code>
      <hc_code>C77</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute lymphoblastic leukemia [ALL]</hc_keyword>
      <hc_keyword>Malignant neoplasm of brain</hc_keyword>
      <hc_keyword>Malignant neoplasm of bone and articular cartilage of limbs</hc_keyword>
      <hc_keyword>Malignant neoplasm of kidney, except renal pelvis</hc_keyword>
      <hc_keyword>Secondary and unspecified malignant neoplasm of lymph nodes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The purpose of the intervention in this study is to hold four sessions with the content of stress reduction based on mindfulness for mothers. The content of the sessions is the first session including introduction, expression of feelings and thoughts, body scan meditation, the second session includes body scan exercise, Three-minute breathing, the third session includes repeating the previous sessions and doing yoga movements. Finally, in the fourth session, the exercises will be reviewed and after completing the sessions, the questionnaires will be completed again. The sessions will be held once a week for a period of 45-120 minutes.</i_keyword>
      <i_keyword>Control group: in the control group, mothers will not participate in mindfulness-based stress reduction sessions and will only complete the Coping Health Inventory for Parents (CHIP)and Kendall Chronic Sorrow Instrument Questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mother's coping behaviors. Timepoint: Before the intervention (before the start of the first session of mindfulness-based stress reduction program) and after the intervention (four weeks after the intervention, ie after four sessions of mindfulness-based stress reduction program once a week). Method of measurement: The McCobin's Coping Health Inventory for Parents (CHIP) Questionnaire.</prim_outcome>
      <prim_outcome>Mother's chronic sorrow. Timepoint: Before the intervention (before the start of the first session of mindfulness-based stress reduction program) and after the intervention (four weeks after the intervention, ie after four sessions of mindfulness-based stress reduction program Once a week). Method of measurement: Kendall Chronic Sorrow Instrument (Persian version).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-03</approval_date>
        <contact_name>Ethics Committee of the Faculty of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of M</contact_name>
        <contact_address>Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
