<?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>IRCT20171209037794N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-04</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Problem-solving skill training and marital satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>Problem-solving skill training and marital satisfaction: A study among primiparous breastfeeding mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31740</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A total of 68 breastfeeding mothers were randomly divided into two groups receiving problem solving skill training (intervention group) or comparison group, based on the blocked randomization with a block size of 4for the two groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Low to moderate marital satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:                                                                                Problem solving skill training in the intervention  group was provided in six 80-minute sessions, in 10–11-person groups.Training sessions focused mainly on breastfeeding-related problems.  All sessions were held in one of the recruited healthcare centers which had better training facilities. All mothers in both groups completed the ENRICH inventory before the intervention, immediately after the sixth training session for the mothers in the experimental group, and one month afterwards.Different content at each session include:                                                                                             The first session: Familiarization of group members with each other; definition of life skills and PSS and the necessity for their training; emotion- and problems-focused coping; emotions and the importance of their management; the phases of PSS; The first step of problem solving (orientation to a problem).                                                                           The second session:  ways to improve orientation to the problem.         The third session: the second step of problem solving (clear definition of the problem).                                                                                                 The fourth session: The third step of problem solving (generating different solutions to the problem) and the fourth step of problem solving (eliminating unfeasible and irrational solutions and selecting the best one).                                                                                                               The fifth session: The use of the ‘advantages-disadvantages’ technique for selecting the best solution. The fifth step of problem solving (implementation and reassessment of the solution).                                The sixth session: using the steps of problem solving for a selected problem; giving the posttest; determining the time for the next posttest at one month after the intervention. Intervention 2: Control group: Mothers in the comparison group received no training.</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 All rights related to the data is for golestan University of Medical Sciences.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gorgan Road to Sari, Golestan University of Medical Sciences</address>
        <city>Gogan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918936316</zip>
        <telephone>+98 11 3221 0056</telephone>
        <email>Fatemeabedi215@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gorgan Road to Sari, Golestan University of Medical Sciences</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918936316</zip>
        <telephone>+98 11 3221 0056</telephone>
        <email>Fatemeabedi215@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Had a childbirth at 37th–42nd weeks of their pregnancy at least two months before the study.
Had a low-to moderate marital satisfaction based on the results of the ENRICH questionnaire.
Did not divorce.
Possessed basic literacy skills.
Only wife of her husband
Had a married life of 1–10 years.
Did not have a baby with major congenital anomalies.
Had a planned pregnancy.
Neither experienced any serious stressful life event during the past three months prior to the study nor suffered from post-natal depression and psychosis.
Lack of serious mental and physical illness (cancer) and advanced chronic diseases.
Had no addiction to opioids, psychoactive agents, and alcohol among the mothers or their husbands.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to respond to more than 5% of the items of the study questionnaire.
Voluntary withdrawal from the study.
Two or more absences from training sessions.
Development of serious health conditions or undergoing any type of surgery during the study.
Participation in any personal or group psychotherapy programs during the study.
A second pregnancy during the study.</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:                                                                                Problem solving skill training in the intervention  group was provided in six 80-minute sessions, in 10–11-person groups.Training sessions focused mainly on breastfeeding-related problems.  All sessions were held in one of the recruited healthcare centers which had better training facilities. All mothers in both groups completed the ENRICH inventory before the intervention, immediately after the sixth training session for the mothers in the experimental group, and one month afterwards.Different content at each session include:                                                                                             The first session: Familiarization of group members with each other; definition of life skills and PSS and the necessity for their training; emotion- and problems-focused coping; emotions and the importance of their management; the phases of PSS; The first step of problem solving (orientation to a problem).                                                                           The second session:  ways to improve orientation to the problem.         The third session: the second step of problem solving (clear definition of the problem).                                                                                                 The fourth session: The third step of problem solving (generating different solutions to the problem) and the fourth step of problem solving (eliminating unfeasible and irrational solutions and selecting the best one).                                                                                                               The fifth session: The use of the ‘advantages-disadvantages’ technique for selecting the best solution. The fifth step of problem solving (implementation and reassessment of the solution).                                The sixth session: using the steps of problem solving for a selected problem; giving the posttest; determining the time for the next posttest at one month after the intervention.</i_keyword>
      <i_keyword>Control group: Mothers in the comparison group received no training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison marital satisfaction  and its dimensions before and after problem solving skill training in experimental and comparison groups. Timepoint: before the intervention, immediately after the intervention and one month afterwards. Method of measurement: ENRICH 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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-03</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Gorgan Road to Sari, Golestan University of Medical Sciences Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
