<?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>IRCT20100919004775N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-14</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the Effects of Virtual Reality, Augmented Reality, and Video-Based Education on Learning, Educational Satisfaction, Self-Efficacy, and Critical Thinking Disposition in Nursing Students Regarding Hemodialysis Machine Preparation, Set-Up, and Priming</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Three Educational Methods—Virtual Reality, Augmented Reality, and Video-Based Training—on Learning, Educational Satisfaction, Self-Efficacy, and Critical Thinking Disposition among Undergraduate Nursing Students in Hemodialysis Machine Set-Up and Priming</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92822</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Training undergraduate nursing students on how to use a hemodialysis machine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: education is provided using Virtual Reality (VR). The educational content is presented as a 360-degree video. Each student individually views the educational content in a quiet environment with safety principles observed, using a dedicated virtual reality headset. Intervention 2: Intervention group 2: Education is provided using Augmented Reality (AR). The educational content is presented as an interactive video incorporating digital information layers into the real environment. Each student individually views the educational content using a dedicated headset. Intervention 3: Intervention group 3:  Education is provided using an educational video. The video contains the same educational content as that provided to the first group and is recorded using a camera in the School of Nursing and Midwifery at Shiraz University of Medical Sciences, with the presence of an instructor.</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:
The study protocol includes information on the clinical trial design and methodology, study population and sample, inclusion and exclusion criteria, participant allocation to the intervention groups, educational methods based on virtual reality, augmented reality, and video-based training, data collection instruments, assessed outcomes, and the timing of outcome assessments.
The statistical analysis plan includes the predefined methods for analyzing the study data, including descriptive analysis of demographic and study variables, assessment of data distribution, selection of appropriate statistical tests for comparing the three educational groups, and analysis of the study outcomes.

When:
Access period starts 12 months after results are published.

To whom:
Eligible researchers and members of research teams who submit a valid research request specifying the purpose and intended use of the data may access the de-identified individual participant data and study documents, subject to approval by the principal investigator and compliance with confidentiality and participant privacy requirements.

Conditions:
Individual participant data will be available in a de-identified form and solely for research purposes and statistical analyses related to the study topic. Access to the data will require a valid research request specifying the purpose and proposed analysis, compliance with confidentiality and participant privacy requirements, obtaining necessary approvals from relevant authorities, and approval by the principal investigator. Use of the data for non-research or commercial purposes, or for any activity that could directly or indirectly identify participants, will not be permitted.

Where to obtain:
Requests for access to de-identified individual participant data and other study documents should be submitted to the principal investigator of the study. Requests will be reviewed based on the research purpose, proposed use of the data, and compliance with confidentiality and participant privacy requirements. Upon approval by the principal investigator and obtaining the necessary permissions, the requested data will be provided to the applicant.

How to obtain:
The requester should submit a request to the principal investigator, specifying the research purpose, intended use of the data, and proposed analyses. The request will be reviewed for scientific relevance, compliance with confidentiality and participant privacy requirements, and consistency with the study objectives. Upon approval by the principal investigator and obtaining the necessary permissions, the de-identified data will be provided to the requester.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zinat Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nemazee Hospital, Nemazee Sq., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>zmohebi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zinat Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nemazee Hospital, Nemazee Sq., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>zmohebi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Providing written informed consent to participate in the study
Being a seventh-semester undergraduate nursing student
Having completed the Hemodialysis Intensive Care course in the previous semester
Having no previous formal training in operating a hemodialysis machine
Having no previous work experience involving the operation of a hemodialysis machine</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Having severe anxiety disorders, as reported by the participant
Failure to attend the educational workshops
Being a guest student
Incomplete completion of the questionnaire (leaving 20% of the questions unanswered)</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: education is provided using Virtual Reality (VR). The educational content is presented as a 360-degree video. Each student individually views the educational content in a quiet environment with safety principles observed, using a dedicated virtual reality headset.</i_keyword>
      <i_keyword>Intervention group 2: Education is provided using Augmented Reality (AR). The educational content is presented as an interactive video incorporating digital information layers into the real environment. Each student individually views the educational content using a dedicated headset</i_keyword>
      <i_keyword>Intervention group 3:  Education is provided using an educational video. The video contains the same educational content as that provided to the first group and is recorded using a camera in the School of Nursing and Midwifery at Shiraz University of Medical Sciences, with the presence of an instructor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The main outcome of student learning in the field of preparing, setting, and priming a hemodialysis machine will be measured using a test designed by the researcher before and immediately after the educational intervention. The learning score and the rate of change in score from pre-test to post-test will be compared in the three groups of virtual reality, augmented reality, and film. In the proposal, learning is also defined operationally based on the scores and difference in scores of the initial and final tests. Timepoint: Before the intervention and immediately after the educational intervention. Method of measurement: Students’ learning regarding the setup and priming of the hemodialysis machine will be measured using a researcher-designed knowledge test. The test will be administered before the intervention as a pre-test and immediately after the intervention as a post-test. The change in learning scores will be compared among the three groups.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Educational satisfaction: The level of students' satisfaction with the educational method received, which will be measured immediately after the intervention using the "Educational Satisfaction Scale" and the scores of the three groups will be compared with each other. Timepoint: Before the intervention and immediately after the educational intervention. Method of measurement: Educational satisfaction: The level of students' satisfaction with the educational method received, which will be measured immediately after the intervention using the "Educational Satisfaction Scale" and the scores of the three groups will be compared with each other.</sec_outcome>
      <sec_outcome>Self-efficacy: The level of students' self-efficacy after receiving the education, which will be measured using the Schwartz and Jerusalem General Self-Efficacy Scale (1981). Timepoint: Before the intervention and immediately after the educational intervention. Method of measurement: The level of students' self-efficacy after receiving the education, which will be measured using the Schwartz and Jerusalem General Self-Efficacy Scale (1981).</sec_outcome>
      <sec_outcome>Critical Thinking Propensity:The level of students' tendency to think critically after the educational intervention, which will be measured using the Ritex Critical Thinking Propensity Questionnaire (2003). Timepoint: Before the intervention and immediately after the educational intervention. Method of measurement: The level of students' tendency to think critically after the educational intervention, which will be measured using the Ritex Critical Thinking Propensity Questionnaire (2003).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-14</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Namazi Square Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
