<?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>IRCT20230713058767N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-05</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of mindful-self compassion program in high risk pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of mindful-self compassion program on distress tolerance, emotion regulation, mindfulness and quality of life in high risk pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization will be simple randomization method. the random unit is individuals. 52 high risk pregnant will be divided into intervention and control groups by Microsoft Excel software using Rand function. in this way, a table of random numbers will be prepared and the Randbetween  function will be created and the high risk will be divided into two groups of 26 people respectively, Blinding description: In the current research, only the statistical analyst will not be involved in the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>High risk pregnant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindful self compassion: education will be 8 sessions in 8 weeks for 2 groups. Each session lasts 45-60 minutes. mindful self compassion therapy includes two parts: mindfulness techniques to reduce rumination and worries about the future, and self-compassion, which includes techniques for behaving and speaking kindly to yourself. Intervention 2: Control group: High-risk pregnant women without 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:
In the current study, except for the confidential information of the clients, including the name and surname, all information including age, occupation, education, language, and social and economic status will be shared.

When:
The time to access information and data will be one week after the results are published.

To whom:
The results of the present study can be available to all people, including workers and researchers in this field and even other fields and the general public.

Conditions:
Researchers and workers in this and other fields can access the results of this study without any restrictions.

Where to obtain:
To access the results of this study, they can refer to the following website.
m.abdollahpur1373@gmail.com

How to obtain:
After the publish of the results of this study, all the results will be available to the requestors of the results without any time limit.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afshin Zarghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, Yas building, 4th floor, Ayatollah Al-Ghani Hospital, Arabi street, Velenjak street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>22439783</telephone>
        <email>m.abdollahpur1373@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Kristin Neff and Dr Christopher Germer</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pschology, Yas building, Ayatollah Taleghani Hospital, Arabi street, velenjak street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2243 9783</telephone>
        <email>m.abdollahpur1373@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gynecologist's diagnosis of high-risk pregnancy (Pregnancies under the age of 18 and over 40, A history of repeated miscarriages, Suspected premature birth, diabetes, etc)
Not undergoing psychotherapy now or in the last 6 months</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Non-pregnant women
Having certain physical diseases such as cancer
Foreign nationals (non-Iranians)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z35.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of pregnancy with other poor reproductive or obstetric history</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindful self compassion: education will be 8 sessions in 8 weeks for 2 groups. Each session lasts 45-60 minutes. mindful self compassion therapy includes two parts: mindfulness techniques to reduce rumination and worries about the future, and self-compassion, which includes techniques for behaving and speaking kindly to yourself.</i_keyword>
      <i_keyword>Control group: High-risk pregnant women without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distress tolerance Being able to handle difficult emotions can help a person more quickly return to a state of equilibrium when new stressors arise. Timepoint: The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months. Method of measurement: Simmons and Gaher Distress Tolerance Questionnaire.</prim_outcome>
      <prim_outcome>Emotion regulation  is a term generally used to describe a person's ability to effectively manage and respond to an emotional experience. Timepoint: The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months. Method of measurement: Gertz and Romer emotion regulation questionnaire.</prim_outcome>
      <prim_outcome>Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment. Timepoint: The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months. Method of measurement: Baer's five-facet questionnaire of self-awareness.</prim_outcome>
      <prim_outcome>Quality of life  as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Timepoint: The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months. Method of measurement: ٌWares Quality of life short form questionnaire.</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>2023-07-22</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Department of Clinical Psychology, Yas building, 4th floor, Ayatollah Taleghani Hospital, Arabi street, velenjak street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
