<?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>IRCT20210612051555N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-30</date_registration>
      <primary_sponsor>Damanhour University- Faculty of Nursing</primary_sponsor>
      <public_title>Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women at Damanhour University: A Randomized Controlled Trial</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women at Damanhour University/Egypt: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>172</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73883</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The target group for this study will be women working in the selected colleges. They were selected using a cluster sampling technique (five colleges). 
- A purposive sample of five colleges from Damanhour University will be selected based on having the highest number of female workers (Education, nursing, commerce, literature, and agriculture colleges) according to the latest data available from the university statistical center. 
- A list will be created with the whole eligible female workers. 
- The lottery system will be deployed by placing all the workers' names in a hat and then randomly selecting our sample without looking. 
-Seventy percent of the female workers from each college will be recruited using the proportional allocation technique. 
- Then they will be equally and randomly assigned to the intervention and comparison groups using a simple random method (Lottery method), Blinding description: The investigator who conducted the statistical analysis will not engaged in the overall data collection process. The investigators who will collect the data enter them into the SPSS program using hidden codes from the analyzer. After finishing the data analysis process using predetermined codes, they will contacted to interpret the codes of both groups: intervention group "A" and comparison group "B.".</study_design>
      <phase>N/A</phase>
      <hc_freetext>Immunity and psychological health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: composed of 88 women who will receive the preplanned intervention. They will receive a total of ten Face-to-Face psychoeducational sessions. The average duration for each session will be 40-50 minutes and will be arranged at the convenience of the working women in each college with adequate meeting space and needed arrangements. During the first month, eight sessions will be delivered, two sessions per week, while during the second month, one session will be conducted every two weeks. In between the sessions, digital supporting, motivating, and follow-up messages will be delivered through the created WhatsApp group on a day-to-day basis. Finally, the follow-up will be accomplished after 3 months (posttest to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results. Intervention 2: Control group: They will be 88 women who will receive nothing. They initially will complete the pre-test and then the post-tests after 3 months, identically to the intervention group. In the end, they will receive the same educational content and assisted materials to preserve their moral and ethical rights and extend the benefits.</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:
Published research report that contains all the findings of the study.

When:
After publication and will be available long life

To whom:
for public

Conditions:
for scientific use and public education

Where to obtain:
Scientific-ranked health journal

How to obtain:
None

Comments:
None</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samiha Hamdi Sayed Ramadan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damanhour, Elbehira, Governorate, Egypt</address>
        <city>Damahour</city>
        <country1>Egypt</country1>
        <zip>22511</zip>
        <telephone>+20 45 3311679</telephone>
        <email>samihareda93@gmail.com</email>
        <affiliation>Damanhour University- Faculty of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samiha Hamdi Sayed Ramadan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damanhour, Elbehira, Governorate, Egypt</address>
        <city>Damahour</city>
        <country1>Egypt</country1>
        <zip>22511</zip>
        <telephone>+20 45 3311679</telephone>
        <email>samihareda93@gmail.com</email>
        <affiliation>Damanhour University- Faculty of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Egypt</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult women working in the selected colleges for at least one year before initiating the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to participate in this study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other reactions to severe stress</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: composed of 88 women who will receive the preplanned intervention. They will receive a total of ten Face-to-Face psychoeducational sessions. The average duration for each session will be 40-50 minutes and will be arranged at the convenience of the working women in each college with adequate meeting space and needed arrangements. During the first month, eight sessions will be delivered, two sessions per week, while during the second month, one session will be conducted every two weeks. In between the sessions, digital supporting, motivating, and follow-up messages will be delivered through the created WhatsApp group on a day-to-day basis. Finally, the follow-up will be accomplished after 3 months (posttest to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results.</i_keyword>
      <i_keyword>Control group: They will be 88 women who will receive nothing. They initially will complete the pre-test and then the post-tests after 3 months, identically to the intervention group. In the end, they will receive the same educational content and assisted materials to preserve their moral and ethical rights and extend the benefits.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived physical immune status. Timepoint: Before and 3 months after the intervention. Method of measurement: Immune Status Questionnaire (ISQ).</prim_outcome>
      <prim_outcome>Perceived psychological immunity. Timepoint: Before and 3 months after the intervention. Method of measurement: Psychological-Immunity Scale (PIS).</prim_outcome>
      <prim_outcome>Perceived Stress level. Timepoint: Before and 3 months after the intervention. Method of measurement: Perceived Stress Scale (PSS).</prim_outcome>
      <prim_outcome>Perceived fatigue level. Timepoint: Before and 3 months after the intervention. Method of measurement: Fatigue Assessment Scale (FAS).</prim_outcome>
      <prim_outcome>Perceived level of Health Lifestyle and Personal Control. Timepoint: Before and 3 months after the intervention. Method of measurement: Health Lifestyle and Personal Control Questionnaire (HLPCQ).</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>Damanhour University- Faculty of Nursing</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-10</approval_date>
        <contact_name>Ethic's committee of the Faculty of Nursing- Damanhour University</contact_name>
        <contact_address>Damanhour, Elbehira, Governorate, Egypt Damanhour Damanhour Egypt</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
