<?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>IRCT20110524006582N34</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-12</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of counseling with stress management approach and communication enhancement approach on sexual satisfaction and marital satisfaction of employed women with high occupational stress</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling with stress management approach and communication enhancement approach on sexual satisfaction and marital satisfaction of employed women with high occupational stress.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50691</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants who completed the pre-test questionnaires randomly using the website www.random.org and through block classification based on work shift (fixed shift or rotating shift) with blocks Six or nine and a 1: 1: 1 allocation ratio to three groups (one group receiving stress management counseling, one group receiving marital relationship enrichment counseling, and one control group). Blocking will be done by a person not involved in sampling and data analysis. To hide the allocation, the type of intervention will be written on paper and placed inside the numbered envelopes, numbered consecutively (Allocation Concealment). The envelopes will be opened in the order in which the participants enter the study and the type of intervention received by them will be determined. In order to prevent contamination, one person will be selected from each section, so that the first person who is eligible and willing to participate in the study will be selected from each section.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Job stress, sexual satisfaction, marital satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving counseling with a stress management approach. In this study, six counseling sessions will be held at intervals of one week for six consecutive weeks with groups of 4 to 6 people. Educational content of stress management approach: Introduction of stress management program, definition of stress and how it affects physical, mental and Social, sources of stress, providing an introduction to the importance and necessity of stress management skills training, addressing the differences between people in the face of stress and the cause of differences, thought-emotional communication, training and discussion about relaxation, stress and awareness, training and discussion of negative thoughts and behaviors, Steps for replacing rational thoughts, examining people's coping styles in stressful situations, introducing problem-oriented and emotion-oriented techniques as coping strategies with stress, objectifying the role of stress in life, cognitive reconstruction, problem solving, time management Positive Thinking, Self-Esteem, Self-Esteem and Dealing with Concerns, Diaphragm Relaxation and Breathing. Intervention 2: Intervention group: Recipient of counseling with relationship enrichment approach. In this study, six counseling sessions will be held at intervals of one week for six consecutive weeks with groups of 4 to 6 people. Speaking and negotiation skills as the first basic skill, self-expression skills training (second skill) and empathy skills (third skill). Enrichment training for couples and conflict resolution skills between them. Problem solving, reviewing problem-solving solutions, paying attention to strengths and weaknesses in dealing with problems. Train your change skills. Intervention 3: Control group: Does not receive any 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Street, Faculty of Nursing Midwifery</address>
        <city>Trizab</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>kamalifardm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Street, Faculty of Nursing Midwifery</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>kamalifardm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Bachelor's degree in nursing and midwifery at the undergraduate level and above
Working women with at least one year of hospital experience (including contract, plan and formal)
Having a spouse alive
Being sexually active and monogamous
Get a score greater than or equal to 100 from the Job Stress Questionnaire
Failure to receive individual counseling services while attending treatment sessions</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a history of physical illnesses affecting sexual desire (having organ lesions, developing a chronic physical illness such as high blood pressure, diabetes)
Stress variables such as disability or illness of a family member (cancer, retardation, etc.)
Occurrence of recent traumatic events and acute stressful problems (death of child, father, etc.)
Having her own mental illness, spouse or family member according to the patient
Smoking, alcohol and drugs and other drugs that affect the body and mind
Menopause
Taking drugs to reduce libido (antidepressants: fluoxetine, sertraline, paroxetine. Antihistamines: chlorpheniramine, drugs that affect blood pressure: clonidine, captopril, benzodiazepines such as alprazolam (Xanax) and .......</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>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving counseling with a stress management approach. In this study, six counseling sessions will be held at intervals of one week for six consecutive weeks with groups of 4 to 6 people. Educational content of stress management approach: Introduction of stress management program, definition of stress and how it affects physical, mental and Social, sources of stress, providing an introduction to the importance and necessity of stress management skills training, addressing the differences between people in the face of stress and the cause of differences, thought-emotional communication, training and discussion about relaxation, stress and awareness, training and discussion of negative thoughts and behaviors, Steps for replacing rational thoughts, examining people's coping styles in stressful situations, introducing problem-oriented and emotion-oriented techniques as coping strategies with stress, objectifying the role of stress in life, cognitive reconstruction, problem solving, time management Positive Thinking, Self-Esteem, Self-Esteem and Dealing with Concerns, Diaphragm Relaxation and Breathing</i_keyword>
      <i_keyword>Intervention group: Recipient of counseling with relationship enrichment approach. In this study, six counseling sessions will be held at intervals of one week for six consecutive weeks with groups of 4 to 6 people. Speaking and negotiation skills as the first basic skill, self-expression skills training (second skill) and empathy skills (third skill). Enrichment training for couples and conflict resolution skills between them. Problem solving, reviewing problem-solving solutions, paying attention to strengths and weaknesses in dealing with problems. Train your change skills.</i_keyword>
      <i_keyword>Control group: Does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison of the mean score of sexual satisfaction, 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) with controlling the effect of baseline score. Timepoint: Before the intervention and 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) by controlling the effect of baseline score. Method of measurement: Larson Sexual Satisfaction Questionnaire.</prim_outcome>
      <prim_outcome>Comparison of the mean score of marital satisfaction, 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) controlling the effect of the base score. Timepoint: Before the intervention and 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) controlling the effect of baseline score. Method of measurement: Enrich Marital Satisfaction Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comparison of mean job stress score 2 weeks after the intervention in control and intervention groups (2 groups receiving counseling) with controlling the effect of baseline score. Timepoint: Before the intervention and 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) by controlling the effect of baseline score. Method of measurement: OSIPO Job Stress Questionnaire.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-25</approval_date>
        <contact_name>Ethics Committee of Research in Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences - Central Organization No. 2 - Vice Chancellor for Research TABRIZ East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
