<?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>IRCT20250415065345N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-31</date_registration>
      <primary_sponsor>Islamic Azad University, Karaj Branch</primary_sponsor>
      <public_title>Effect of Team-Based Learning and Jigsaw on Knowledge and Self-Efficacy of Nursing Students in Palliative Care</public_title>
      <acronym>TJL-PaN(مخفف: Team-based &amp; Jigsaw Learning in Palliative Nursing)</acronym>
      <scientific_title>Comparison of The Effect of Team-Based Learning and Jigsaw on The Knowledge And Self-Efficacy of Nursing Students in Palliative Care</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This study is a quasi-experimental, three-arm trial (two intervention groups and one control group) using stratified randomization. Educational interventions are delivered through two innovative teaching methods: Jigsaw and Team-Based Learning. Importantly, the educational content, duration, classroom environment, and instructor are kept identical across both intervention groups to ensure that only the teaching method serves as the independent variable. Additionally, questionnaires are administered at three time points (pre-test, post-test, and one-month follow-up) to assess the sustainability of the educational impact. The control group receives no educational intervention and is included solely for comparison and to control for potential confounding factors, Randomization description: Stratified randomization will be used to ensure balanced distribution of background variables such as academic semester, GPA, and gender across the study groups. The unit of randomization is the individual student. Participants will be first categorized into strata based on their semester, GPA, and gender. Within each stratum, random allocation to one of the three groups—Jigsaw, Team-Based Learning, or Control—will be performed.

The random sequence will be generated using statistical software (e.g., SPSS or R). Allocation concealment will be ensured by having an independent person, not involved in the implementation of the intervention, manage the randomization list. The allocation sequence will be stored in a secured file and only accessed after participant enrollment to prevent selection bias, Blinding description: In this study, due to the educational nature of the interventions, participants were aware of the group they were assigned to (Jigsaw, Team-Based Learning, or Control). The researcher, intervention instructors, and outcome assessors were also aware of the intervention type. However, in order to reduce bias in data interpretation, the data analyst was blinded to the group assignments, and statistical analysis was conducted using anonymized, coded datasets. No Data Safety and Monitoring Board (DSMB) was established for this study. While participants were not blinded, the presence of blinding at the data analysis level provides a single level of blinding in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Palliative care, Advanced chronic diseases, Cancer, End-of-life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Training is delivered using the Jigsaw method in four sessions. The educational content covers the basics of palliative care and is provided through booklets and oral presentations by the researcher. Each session includes small group formation, topic division, individual study, peer teaching, and researcher-led summarization. Each session lasts between sixty and ninety minutes. Intervention 2: Control Group: Participants in this group will not receive any educational intervention related to palliative care. They will only complete the study questionnaires at three time points: before the intervention, immediately after, and one month later. To ensure ethical considerations, the educational content will be provided to control group participants in digital format after data collection is completed. Intervention 3: Intervention Group 2: Training is conducted using the Team-Based Learning method in four similar sessions. In this approach, students first study the material individually, then collaborate in groups to solve problems and answer questions. The researcher concludes each session with a summary and clarification. The content, timing, and session structure are identical to Group 1.</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:
De-identified individual participant data related to the primary outcome variables, including knowledge, self-efficacy, and satisfaction scores. These data will be shared in Excel format upon written request and approval by the ethics committee. Additional documents such as the full study protocol and statistical analysis plan will also be available upon request.

When:
Access to the data will begin three months after publication of the main study results and will remain available for a period of two years to qualified researchers with a valid written request.

To whom:
Access to the data will be granted to researchers affiliated with universities, academic institutions, and research centers. Requests must be accompanied by an official letter of introduction and approval from the applicant’s institutional ethics committee.

Conditions:
The data may only be used for scientific and research purposes; commercial use is not permitted. Analyses must align with the original objectives of the study, and misleading or unrelated analyses are not allowed. Applicants must submit a research proposal, an official letter of introduction, and ethics committee approval from their institution. Data use will be subject to signing a data sharing agreement.

Where to obtain:
Applicants seeking access to the study data or documents may contact the principal investigator, Ms. Sharareh Zeyghami Mohammadi, via email. The request must include a research proposal, an official letter of introduction, and ethics committee approval.

Contact Person: Sharareh Zeyghami Mohammadi
Position: Faculty Member, Faculty of Nursing and Midwifery, Islamic Azad University, Karaj Branch
Postal Address: Faculty of Nursing and Midwifery, Islamic Azad University, Moazen Boulevard, Rajaei Shahr, Karaj, Postal Code: 3149968111
Email: sharareh.zeyghami@iau.ac.ir 
Phone: +98 26 34203590

How to obtain:
After submitting a written request including a research proposal, an official letter of introduction, and ethics committee approval from the applicant’s institution, the request will be reviewed by the research team within 2 weeks. If approved, a data sharing agreement will be sent to the applicant for signature. Once the signed agreement is received, the requested data or documents will be shared via email or a secure cloud platform within a maximum of 2 weeks. The entire process typically takes 3 to 4 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sharareh Zeyghami Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Karaj Branch, Moazen Boulevard, Rajaei Shahr, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3420 3590</telephone>
        <email>rezajamshidi2018@gmail.com</email>
        <affiliation>Islamic Azad University, Karaj Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sharareh Zeyghami Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Karaj Branch, Moazen Boulevard, Rajaei Shahr, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3420 3590</telephone>
        <email>rezajamshidi2018@gmail.com</email>
        <affiliation>Islamic Azad University, Karaj Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Undergraduate nursing students
Currently enrolled in semesters 3 to 6
At least one semester of clinical experience
Willingness to participate in the study
Completion of written informed consent form
No prior participation in palliative care training courses</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No clinical experience.
Previous participation in palliative care training courses
Unwillingness to participate in the study.
Failure to complete the written informed consent form
Enrollment in semesters other than 3 to 6 (i.e., semesters 1–2 or beyond 6)</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>N/A</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Training is delivered using the Jigsaw method in four sessions. The educational content covers the basics of palliative care and is provided through booklets and oral presentations by the researcher. Each session includes small group formation, topic division, individual study, peer teaching, and researcher-led summarization. Each session lasts between sixty and ninety minutes.</i_keyword>
      <i_keyword>Control Group: Participants in this group will not receive any educational intervention related to palliative care. They will only complete the study questionnaires at three time points: before the intervention, immediately after, and one month later. To ensure ethical considerations, the educational content will be provided to control group participants in digital format after data collection is completed.</i_keyword>
      <i_keyword>Intervention Group 2: Training is conducted using the Team-Based Learning method in four similar sessions. In this approach, students first study the material individually, then collaborate in groups to solve problems and answer questions. The researcher concludes each session with a summary and clarification. The content, timing, and session structure are identical to Group 1.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of knowledge in palliative care measured by the Palliative Care Quiz for Nurses (PCQN) developed by Ross et al. (1996), consisting of 20 multiple-choice items (true, false, do not know); higher scores indicate greater knowledge. Assessment occurs at three time points: before the intervention, immediately after, and one month later.Score of self-efficacy in palliative care measured by the Palliative Care Self-Efficacy Scale developed by Phillips et al. (2011), evaluating students’ perceived ability to manage symptoms and provide psychosocial support; higher scores indicate higher self-efficacy. Measured at three time points: before the intervention, immediately after, and one month later. Timepoint: Measurements will be conducted at three time points: before the start of the educational intervention, immediately after the completion of the sessions, and one month after the intervention. Method of measurement: The level of knowledge will be measured using the “Palliative Care Quiz for Nurses” developed by Ross and colleagues in the year nineteen ninety-six.The level of self-efficacy will be assessed using the “Palliative Care Self-Efficacy Scale” developed by Phillips and colleagues in the year two thousand eleven.The level of educational satisfaction will be measured using the “Satisfaction with Teaching Method Questionnaire” developed by Sadeghnejad and colleagues in the year two thousand thirteen.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The students’ satisfaction score with the received teaching method will be measured using the “Satisfaction with Teaching Method Questionnaire” developed by Sadeghnejad and colleagues in the year two thousand thirteen; higher scores indicate greater satisfaction with the instructional approach. Timepoint: The level of satisfaction with the teaching method will be measured immediately after the completion of the educational sessions in both intervention groups. Method of measurement: The level of students’ satisfaction with the teaching method will be measured using the “Satisfaction with Teaching–Learning Strategy Questionnaire” developed by Sadeghnejad and colleagues in the year two thousand thirteen. Higher scores indicate greater satisfaction with the teaching method.</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>Islamic Azad University, Karaj Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-26</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Karaj Branch</contact_name>
        <contact_address>Shahid Moazen Boulevard Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
