<?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>IRCT20201214049706N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-01</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Mindfulness-Based Counseling and Training of Effective Communication Skills with the Spouse on Nausea and Vomiting in Pregnant Women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Mindfulness-Based Counseling and Training of Effective Communication Skills with the Spouse on Nausea and Vomiting in Pregnant Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52987</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random sequence is prepared by the statistical consultant professor and using Online software, a random table for 150 people is provided to the researcher.
Given that we have three groups of comparisons, the type of randomization is based on 6 random blocks. The number of blocks is 25 6 blocks that will be prepared using the Sequence table software.
The allocation of participants is done using concealment with the method of closed envelopes. In this method, the sequence table designed in the previous section is used.
Due to the fact that the type of intervention is known, there is no possibility of blindness.</study_design>
      <phase>3</phase>
      <hc_freetext>Nausea and Vomiting in Pregnant Women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group (A): In this study, 4 sessions of counseling based on mindfulness are 90 minutesMindfulness skills training: Session 1: Part 1: Communicating with clients and obtaining information from them; Automatic Thought Identification Introducing Model Self-Regulation: Raisin Exercise; Introduction Focus on focus with practice in the session. Assignment: Meditation with tape (continued during the experimental period). Part II: Assisting clients in recognizing these thoughts, and teaching the use of thought recording, teaching cognitive distortion to clients. Brief meditation (after each session); Practice mindful eating (cheese and sweet crackers); Conceptual and mental eating; bodyscan. Assignment: Eat 1 snack meal (the rest in the remaining period by increasing the number of grains / snacks) Session 2: Part 1: Diaphragm breathing training and sleep hygiene. Exercise with the wrong adjustment (sweet, high-fat food). Homework: Mini-meditation before mealsScratch 2: Assisting clients in recognizing these thoughts, and teaching the use of thought recording, teaching cognitive distortion to clients. Brief meditation (after each session); Practice mindful eating (cheese and sweet crackers); Conceptual and mental eating; bodyscan. Assignment: Eat 1 snack meal (the rest in the remaining period by increasing the number of grains / snacks) Session 2: Part 1: Diaphragm breathing training and sleep hygiene. Exercise with the wrong adjustment (sweet, high-fat food). Assignment: Mini-meditation before the second meal: training to adjust the mind and label the mind for thoughts, feelings, behaviors. Increase recognition of the personal consequences of chronic anxiety, conduct low-cost analysis of chronic anxiety of clients. Forgiveness meditation. Homework: Eat all meals and snacks carefullySession 3: Part 1: Visual nausea or vomiting; Sitting Yoga Wise Tactics Walking Meditation ÷ Assignment: Participate in Satisfaction and Enjoyment, Enjoy Mineral Foods and Eat / Chopped Foods Part II :: Generating the Hierarchy of Others, Imagination, Facing Acceptance, Exposing Inside Exposure Through Increase Planned Partnership Session 4: Part One: Generating the Hierarchy of Others, Imaginations, Facing Acceptance, Exposing Internal Exposure through Increased Planned Participation Creating a Hierarchy Concerns About Bodybuilding Concerns About Relationships Imagination with Accepting Exposure In vivo by increasing participation Participation in subsequent planning of pregnancy and childbirthPart 2: Review the progress of browsing and techniques in a way that is most useful for review. Other activities Other meetings. Intervention 2: Intervention group (B): 4 90-minute sessions of training communication skills training with spouse..Effective communication training: Intervention group (a): In this study, 4 sessions of counseling based on mindfulness are 90 minutes. Session 1: Part 1: Introducing the group and members to each other, familiarity with the working method and structure of the sessions, examining expectations from the program Part II: Increasing Self-Awareness, Emphasizing the Importance of Self-Confidence Session Two: Part One: Identifying Couples 'Beliefs and Expectations about Happiness Part Two: Demonstrating the Impact of Beliefs on Individuals' Feelings and BehaviorSession 3: Part One: Listening Skills Training Part Two: Speaking Skills Training Session Four: Part One: Assessing Conflict Resolution Skills, Training and Practicing Conflict Resolution Skills Part Two: Summarizing and Answering Questions and Performing Post-Test.</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:
Score of nausea and vomiting in pregnant women before and after mindfulness counseling and effective communication training sessions and the content of mindfulness counseling and effective communication training sessions

When:
Since the publication of the article, it is possible to access valid sites

To whom:
researchers

Conditions:
With the consent of all members of the research team, the data can be transferred

Where to obtain:
Email the free goddess elaheh.azadbash@gmail.com

How to obtain:
By requesting an email to the goddess Azadbash elaheh.azadbash@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elaheh Azadbash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Helal Ahmar 7</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514815341</zip>
        <telephone>+98 23 3343 7612</telephone>
        <email>elaheh.zadbash@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elaheh Azadbash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Helal Ahmar 7</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514815341</zip>
        <telephone>+98 23 3343 7612</telephone>
        <email>elaheh.azadbash@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mild and higher nausea according to the Rhodes Pregnancy Nausea and Vomiting Questionnaire of pregnancy
Gestational age from 8 to 22 weeks
Single pregnancy
The mother has the ability to use a smartphone or Labtab, etc. that can make Internet calls
Willingness to participate in the project</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>- Loss of pregnancy
Dissatisfaction of the pregnant woman to continue cooperation
Simultaneous physical illness that leads to nausea and vomiting such as acute pyelonephritis and any gastrointestinal disease leading to nausea and vomiting
History of hospitalization due to neurological problems
Maternal physical problems that prevent the mother from participating in the 90-minute class</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group (A): In this study, 4 sessions of counseling based on mindfulness are 90 minutesMindfulness skills training: Session 1: Part 1: Communicating with clients and obtaining information from them; Automatic Thought Identification Introducing Model Self-Regulation: Raisin Exercise; Introduction Focus on focus with practice in the session. Assignment: Meditation with tape (continued during the experimental period). Part II: Assisting clients in recognizing these thoughts, and teaching the use of thought recording, teaching cognitive distortion to clients. Brief meditation (after each session); Practice mindful eating (cheese and sweet crackers); Conceptual and mental eating; bodyscan. Assignment: Eat 1 snack meal (the rest in the remaining period by increasing the number of grains / snacks) Session 2: Part 1: Diaphragm breathing training and sleep hygiene. Exercise with the wrong adjustment (sweet, high-fat food). Homework: Mini-meditation before mealsScratch 2: Assisting clients in recognizing these thoughts, and teaching the use of thought recording, teaching cognitive distortion to clients. Brief meditation (after each session); Practice mindful eating (cheese and sweet crackers); Conceptual and mental eating; bodyscan. Assignment: Eat 1 snack meal (the rest in the remaining period by increasing the number of grains / snacks) Session 2: Part 1: Diaphragm breathing training and sleep hygiene. Exercise with the wrong adjustment (sweet, high-fat food). Assignment: Mini-meditation before the second meal: training to adjust the mind and label the mind for thoughts, feelings, behaviors. Increase recognition of the personal consequences of chronic anxiety, conduct low-cost analysis of chronic anxiety of clients. Forgiveness meditation. Homework: Eat all meals and snacks carefullySession 3: Part 1: Visual nausea or vomiting; Sitting Yoga Wise Tactics Walking Meditation ÷ Assignment: Participate in Satisfaction and Enjoyment, Enjoy Mineral Foods and Eat / Chopped Foods Part II :: Generating the Hierarchy of Others, Imagination, Facing Acceptance, Exposing Inside Exposure Through Increase Planned Partnership Session 4: Part One: Generating the Hierarchy of Others, Imaginations, Facing Acceptance, Exposing Internal Exposure through Increased Planned Participation Creating a Hierarchy Concerns About Bodybuilding Concerns About Relationships Imagination with Accepting Exposure In vivo by increasing participation Participation in subsequent planning of pregnancy and childbirthPart 2: Review the progress of browsing and techniques in a way that is most useful for review. Other activities Other meetings</i_keyword>
      <i_keyword>Intervention group (B): 4 90-minute sessions of training communication skills training with spouse..Effective communication training: Intervention group (a): In this study, 4 sessions of counseling based on mindfulness are 90 minutes. Session 1: Part 1: Introducing the group and members to each other, familiarity with the working method and structure of the sessions, examining expectations from the program Part II: Increasing Self-Awareness, Emphasizing the Importance of Self-Confidence Session Two: Part One: Identifying Couples 'Beliefs and Expectations about Happiness Part Two: Demonstrating the Impact of Beliefs on Individuals' Feelings and BehaviorSession 3: Part One: Listening Skills Training Part Two: Speaking Skills Training Session Four: Part One: Assessing Conflict Resolution Skills, Training and Practicing Conflict Resolution Skills Part Two: Summarizing and Answering Questions and Performing Post-Test</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and Vomiting in Pregnant Women. Timepoint: In the fourth intervention session. Method of measurement: Nausea and vomiting 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-08</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Unit: 6, floor 4,No. 34, Helal ahmar 7 Ave., Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
