<?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>IRCT20150731023423N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-11</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of counseling with hope therapy approach on improving perceived stress and quality of life of women suffering from nausea and vomiting of pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling with hope therapy approach on improving perceived stress and quality of life of women suffering from pregnancy nausea and vomiting</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71004</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible women will be selected during routine prenatal care and then will be allocated into two intervention ans control groups using the block random allocation method with a block size of 4; For this purpose, blocks of 4 will be selected using a table of random numbers in the size of 17 blocks so that the sample size reaches 68 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Quality of life in women with pregnancy nausea and vomiting. Condition 2: Perceived Stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Hope counselling will be conducted in a group format. It will consist of 8 sessions, held twice a week, with each session lasting 90 minutes at the Comprehensive Health Centers in Zanjan City. The content of the sessions will be designed based on the developed treatment plan by Snyder. In the hope therapy sessions, women will become familiar with concepts such as hope, understanding the growth of hope, and the necessity of hope in life. Individuals will be encouraged to express their life stories, current events, and important dimensions of life. They will prioritize life events based on their importance, set goals for each area of life, develop pathways and appropriate strategies to achieve the set goals and transform these pathways into small steps and motivating pathways. Ultimately, individuals are expected to practice positive thinking in their daily lives. Intervention 2: Control group: The control group will be received the usual prenatal care and diet.</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 The possibility of dissatisfaction of the participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Piri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences, Gavazang Road, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>0098 024 334206519</telephone>
        <email>mahsapiri3226006@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>اعظم ملکی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>0098 3342 24 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>Gestation age 6 to 12 weeks
Low risk pregnancy
Wanted pregnancy
Obtaining a score of 17-32 based on  the Rhodes Nausea and Vomiting Questionnaire
Obtaining a score of 18-36 based on Cohen's Perceived Stress Questionnaire
Singleton pregnancy based on ultrasound</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from chronic diseases
Suffering from depression (getting a score of 12 or more from the Edinburgh Questionnaire)
Suffering from digestive diseases
Taking psychiatric drugs
Drug and psychedelic use
Experiencing traumatic and stressful events in the last 3 months
Symptoms of miscarriage
Presence of molar or ectopic pregnancy
Presence of ectopic pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code>F43.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Reaction to severe stress, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Hope counselling will be conducted in a group format. It will consist of 8 sessions, held twice a week, with each session lasting 90 minutes at the Comprehensive Health Centers in Zanjan City. The content of the sessions will be designed based on the developed treatment plan by Snyder. In the hope therapy sessions, women will become familiar with concepts such as hope, understanding the growth of hope, and the necessity of hope in life. Individuals will be encouraged to express their life stories, current events, and important dimensions of life. They will prioritize life events based on their importance, set goals for each area of life, develop pathways and appropriate strategies to achieve the set goals and transform these pathways into small steps and motivating pathways. Ultimately, individuals are expected to practice positive thinking in their daily lives.</i_keyword>
      <i_keyword>Control group: The control group will be received the usual prenatal care and diet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention, 8 weeks after the end of the intervention. Method of measurement: The Pregnancy  Nausea and Vomiting  Quality of Life.</prim_outcome>
      <prim_outcome>Perceived Stress. Timepoint: Before the intervention, 8 weeks after the end of the intervention. Method of measurement: Cohen's Perceived Stress Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hope for Life. Timepoint: Before intervention and 8 weeks after the completion of counseling sessions. Method of measurement: Hope for Life Scale.</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>2023-06-27</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Jomhori Eslami Ave, Azadi Square,The first floor of  Deputy of research and technology of Zanjan University of Medical  sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
