<?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>IRCT20150731023423N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-31</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>"The Effec of Consultation Using Positive Approach on Maternal Adaptation and  Severity of Pregnancy of Nausea and Vomiting"</public_title>
      <acronym></acronym>
      <scientific_title>The Effec of Consultation Using Positive Approach on Maternal Adaptation and  Severity of Pregnancy of Nausea and Vomiting</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48117</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible Women Will be Selected Using the Convenience Sampling Method. According to the Sample Size, They Will be Randomly Allocated to the Intervention and Control Groups Using Randomized 4-Block by Table of Random Number.The Sequence of Blocks Will be Placed on a Separate Sheet Inside the Matte Envelope. In the Present Study, We do not Have Blinding.</study_design>
      <phase>3</phase>
      <hc_freetext>Pregnancy Nausea and Vomiting.</hc_freetext>
      <i_freetext>Intervention Group, 6 Sessions Positive Counseling Based on The Protocol of Sligman et al. (2006) will be Received Individually From The 6th Week of Gestation. Each Session will be Done 45 Minutes in Three Times a Week.The Content of The Sessions Includes The Introduction of Three Paths to Happiness (Enjoyment, Commitment, and Meaning in Life) in The Form of a Practice of Forgiveness in Life, a Discussion of Meaning in Life and Its Role in Reducing Negative Emotions, Optimism, Life Satisfaction, Enjoying The Moments and Situations That They Have, Practicing Personal Heritage Skills, Training Subjects to Control Emotions, Acquainting People With Positive Emotions and Its Role in Reducing Pregnancy-related Stressors, Familiarity With One's Abilities and The Role of Support From Other Family Members and Spouse in Adapting to Pregnancy, Reviewing People's Attitudes Towards Commitment and Responsibility in Life and Pregnancy, Practicing The Art of Appreciation in Life, Practicing Thanksgiving in Life, Practicing The Skill of Remembering Three Blessings a Day, Learning to Improve Positive Social Relationships, Constructive Active Response Techniques Will be Discussed.The Control Group Will be Received Only Routine Care, Which Includes Lifestyle Modification to Control Nausea and Vomiting During Pregnancy According to The Protocol of The Ministry of Health,.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Possibility of Dissatisfaction of Participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing and midwifery ,Zanjan University of Medical Sciences, Gavazang Road, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24 3234 5031</telephone>
        <email>mina.abbac@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second Building, First Floor, Social Determinants of Health"Research Center "Vice Chancellor for Research and TechnologyIran, Zanjan University of Medical Sciences,Azadi Blvd, Zanjan,Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24 3342 0651</telephone>
        <email>Malekia@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having  3-16  Scores Based on RHODES' Pregnancy Nausea and Vomiting Questionnaire
Gestational Age 6-10 Weeks
Wanted Pregnancy
Phone Access
Normal Pregnancy
The Lack of Chronic Disease
The lack of Psychological disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having of High-risk Pregnancy Symptoms
Occurrence of Severe Stressful Events Such as Divorce or Death of Loved Ones
Not Desire to Continue to Participate in The Study
More Than Two Absence in Counseling Sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O21.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild hyperemesis gravidarum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group, 6 Sessions Positive Counseling Based on The Protocol of Sligman et al. (2006) will be Received Individually From The 6th Week of Gestation. Each Session will be Done 45 Minutes in Three Times a Week.The Content of The Sessions Includes The Introduction of Three Paths to Happiness (Enjoyment, Commitment, and Meaning in Life) in The Form of a Practice of Forgiveness in Life, a Discussion of Meaning in Life and Its Role in Reducing Negative Emotions, Optimism, Life Satisfaction, Enjoying The Moments and Situations That They Have, Practicing Personal Heritage Skills, Training Subjects to Control Emotions, Acquainting People With Positive Emotions and Its Role in Reducing Pregnancy-related Stressors, Familiarity With One's Abilities and The Role of Support From Other Family Members and Spouse in Adapting to Pregnancy, Reviewing People's Attitudes Towards Commitment and Responsibility in Life and Pregnancy, Practicing The Art of Appreciation in Life, Practicing Thanksgiving in Life, Practicing The Skill of Remembering Three Blessings a Day, Learning to Improve Positive Social Relationships, Constructive Active Response Techniques Will be Discussed.The Control Group Will be Received Only Routine Care, Which Includes Lifestyle Modification to Control Nausea and Vomiting During Pregnancy According to The Protocol of The Ministry of Health,</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of Pregnancy Nausea and Vomiting. Timepoint: Before Intervention, Daily  up to two Weeks, Immediately After Intervention, and Four Weeks After Intervention. Method of measurement: RHODES' Nausea and Vomiting Severity Questionnaire.</prim_outcome>
      <prim_outcome>Coping With Pregnancy. Timepoint: Before Intervention, Immediately After Intervention, and Four Weeks After Intervention. Method of measurement: Coping  With Pregnancy Questionnaire NuPCI.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of Nausea and Vomiting. Timepoint: Before  Intervention, The End of The Intervention and 4 Weeks After The Intervention. Method of measurement: Reduz Nausea and Vomiting questionnaire.</sec_outcome>
      <sec_outcome>Coping with pregnancy. Timepoint: Before Intervention, and 4 weeks after  Intervention. Method of measurement: Hamilton coping with pregnancy.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-14</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Second building, first floor, Deputy of Research and Technology,,Zanjan University of Medical Sciences,  Azadi Blvd, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
