<?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>IRCT20180408039229N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-03</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of mindfulness on sleep quality</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of mindfulness group based counseling on sleep quality in nulliparous pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30496</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization method: Restricted randomization with block randomization permuted 
Random unit: Individual
permuted block randomization via random sequence generation. For this purpose scores is arranged in ascending order and placed between two and two to the control and test groups.
also In the randomization process, the person involved in the creation of a random program will be distinct from other researchers, to reduce the probable bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>poor sleep quality during pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will counsel in 6 to 12 people, 120 consecutive minutes will be subject to group counseling during the 8 weekly sessions.Session 1: Participants are asked to introduce themselves at the first meeting. The researcher will give them a brief summary of 8 sessions. Afterwards, participants will be asked eating a raisin number with all the emotions and discussing this feeling in the future. Body scan is then performed for 30 minutes. Second session: Participants will encourage their body scans to meditate, and discuss their experiences with their homework experience. After that, discussing the barriers to practicing and solving the mindfulness program is discussed. Then discusses the difference between thoughts and feelings and finally meditate in a sitting position.Session 3: Begins with the practice of seeing and hearing. In this exercise, participants are asked to look in a non-judgmental fashion for 2 minutes and listen. At the fourth session, with attention to breathing, body sounds and thoughts begin. In the following, discuss stress responses and one's reaction to difficult situations and alternative behaviors, and at the end of the session, walking into the conscious mind is practiced. At the fifth session, participants are asked to take meditation sessions. In the second part of the second cycle, the conscious movements of the body are presented and implemented. The sixth session begins with a three-minute breathing exercise. After that, the practice is presented with this theme: the content of the thoughts are not mostly real. Seventh session begin With a four-dimensional and intelligible mediation, he will be alert to everything at the moment.The theme of this meeting is: What is the best way to self care? Session 8: After performing meditation, body scan and 3-minute breathing exercises; the methods of coping with barriers to mediation is discussed. Then, in the case of the whole session, questions about what do participants feel that their coping skills have increased and whether they want to continue their meditation exercises; it will be discussed. Intervention 2: Control group: There is no 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:
After being unidentified, sharing information on the main outcome can be shared.

When:
There will be access 6 Month after publication

To whom:
Researchers working in academic institutions

Conditions:
More advanced analyzes on the main outcome, provided the written consent of the researchers.

Where to obtain:
Email

How to obtain:
3 month after email to the Correspondence author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narjes Sadat Borghei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Ahoo appartment., Sayade5., Sayad shirazy Blvd.,</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917977738</zip>
        <telephone>+98 17 3254 9718</telephone>
        <email>dr.borghei@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narjes Sadat Borghei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Ahoo appartment., Sayade5., Sayad shirazy Blvd</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917977738</zip>
        <telephone>+98 17 3254 9718</telephone>
        <email>dr.borghei@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nulliparous Pregnant women
Gestational age between 14 to 24 weeks.
Pregnant women with poor sleep quality that score 5 or more than 5 of the Pittsburgh Sleep Quality Index.
Have read and write literacy.
By the end of pregnancy, they should be residents of Gorgan.
fluent in Farsi</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Experience a severe stressful event during the past 3 months (eg accident accident, the death of one of the first-degree relatives)
High-risk pregnancy based on the country's guidelines for the provision of obstetric and obstetric services
The use of hypnotic and analgesic drugs
Participate in similar training courses in pregnancy (such as attending special pregnancy classes)
infertility History
drug misuse, psychotropic or alcohol abuse
woman having a known psychological illness and the use of psychiatric drugs or physical illnesses (cancers) and chronic diseases in the last few months
shift in working hours and night work</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group will counsel in 6 to 12 people, 120 consecutive minutes will be subject to group counseling during the 8 weekly sessions.Session 1: Participants are asked to introduce themselves at the first meeting. The researcher will give them a brief summary of 8 sessions. Afterwards, participants will be asked eating a raisin number with all the emotions and discussing this feeling in the future. Body scan is then performed for 30 minutes. Second session: Participants will encourage their body scans to meditate, and discuss their experiences with their homework experience. After that, discussing the barriers to practicing and solving the mindfulness program is discussed. Then discusses the difference between thoughts and feelings and finally meditate in a sitting position.Session 3: Begins with the practice of seeing and hearing. In this exercise, participants are asked to look in a non-judgmental fashion for 2 minutes and listen. At the fourth session, with attention to breathing, body sounds and thoughts begin. In the following, discuss stress responses and one's reaction to difficult situations and alternative behaviors, and at the end of the session, walking into the conscious mind is practiced. At the fifth session, participants are asked to take meditation sessions. In the second part of the second cycle, the conscious movements of the body are presented and implemented. The sixth session begins with a three-minute breathing exercise. After that, the practice is presented with this theme: the content of the thoughts are not mostly real. Seventh session begin With a four-dimensional and intelligible mediation, he will be alert to everything at the moment.The theme of this meeting is: What is the best way to self care? Session 8: After performing meditation, body scan and 3-minute breathing exercises; the methods of coping with barriers to mediation is discussed. Then, in the case of the whole session, questions about what do participants feel that their coping skills have increased and whether they want to continue their meditation exercises; it will be discussed.</i_keyword>
      <i_keyword>Control group: There is no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality during pregnancy. Timepoint: Before the intervention, the end of the intervention and one month after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-25</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Research Deputy of Golestan University of Medical Sciences, Beginning of the Road of Shasta Kalateh., 5th Km of Gorgan Kurdkuy Road Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
