[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658487":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":42,"overallOfficials":47,"centralContacts":54,"locations":27,"responsibleParty":60,"collaborators":27,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":27,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":27,"maxAge":27,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":90,"whyStopped":27,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":27},{"fullName":5,"class":6},"Duzce University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Assisted Reproductive Technologies Knowledge Score","Change in students' knowledge regarding assisted reproductive technologies, assessed using the researcher-developed Assisted Reproductive Technologies Knowledge Test. The knowledge test was developed by the researchers based on the relevant literature and study objectives. The content validity of the test was evaluated through expert review, and a preliminary application was conducted with students from a different group who were not included in the main study. Item difficulty analyses were performed based on the preliminary application to evaluate the appropriateness and discriminatory characteristics of the test items. Higher scores indicate a higher level of knowledge regarding assisted reproductive technologies.","At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Change in Effective Communication Skills","Effective communication skills will be assessed at T0, T1, T2, and T3 using the Effective Communication Skills Scale. The scale consists of 34 items and five subdimensions: ego-enhancing language, active listening, self-awareness\u002Fself-disclosure, empathy, and use of \"I\" language. It uses a 5-point Likert-type response format, with higher scores indicating better effective communication skills.Cronbach alfa value is 0.93 for the full scale, and 0.85, 0.90, 0.78, 0.91, and 0.53 for the Ego Supportive Language, Active-Participative Listening, Self-recognition\u002FSelf-disclosure, Empathy, and I-language sub-dimensions, respectively.",{"measure":18,"description":19,"timeFrame":12},"Change in Anxiety Level","Anxiety will be assessed at T0, T1, T2, and T3 using the State-Trait Anxiety Inventory (STAI). The STAI is a 40-item self-report instrument consisting of two subscales: State Anxiety and Trait Anxiety, with 20 items in each subscale. Items are rated on a 4-point response scale. Higher scores indicate higher levels of anxiety. The Turkish version of the STAI has been adapted and validated for use in Turkish populations. Cronbach's alpha coefficients were reported as 0.92 for state anxiety and 0.87 for trait anxiety.",{"measure":21,"description":22,"timeFrame":12},"Change in Self-Efficacy","Self-efficacy will be assessed at T0, T1, T2, and T3 using the Student Self-Efficacy Scale. The scale consists of 10 items and has a single-factor structure. It is a self-report measure developed to assess students' perceived self-efficacy. Higher scores indicate higher levels of self-efficacy. The Turkish version of the scale has demonstrated acceptable validity and reliability among undergraduate nursing students.The Cronbach's alpha coefficient was 0.81, while corrected item-total correlations ranged from 0.45 to 0.56.",{"measure":24,"description":25,"timeFrame":26},"Change in Simulation Skill Performance","Simulation skill performance will be assessed during the first and second simulation sessions (T2 and T3) using the researcher-developed Skill Assessment Form. The form was developed based on the study objectives and relevant literature, and its content was evaluated through expert review. The form evaluates students' performance in communicating with the female patient and male partner, explaining the stages of assisted reproductive treatment and the role of the male partner, preparing and administering gonadotropin medication, and providing education on medication administration. Higher scores indicate better performance.","Skills will be assessed at two time points: immediately after the first simulation (Week 8) and immediately after the second simulation (Week 12), with a 4-week interval between assessments.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":6,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","This is a single-group interventional study. All participants will receive the same structured theoretical and video-based education and participate in two scenario-based hybrid simulation sessions. The 30 participants will be randomly assigned to 15 simulation groups of two students each for the implementation of the simulation sessions. Random assignment will be used only to form simulation groups; there will be no separate intervention or control groups.",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","This study will use a single-group quasi-experimental design with repeated measurements. Participants will be third-year nursing students enrolled in the Assisted Reproductive Technologies and Nursing course at Düzce University Faculty of Health Sciences. After providing informed consent, baseline assessments (T0) will be conducted using the Introductory Information Form, anxiety, effective communication, self-efficacy, and assisted reproductive technologies knowledge measures.\n\nParticipants will then receive six weeks of structured theoretical education and video-based training. At the end of this period, the same outcome measures will be administered at T1. Participants will subsequently take part in the first scenario-based hybrid simulation involving a standardized female patient, a standardized male partner, and an injection model. The simulation will focus on assisted reproductive treatment stages, patient education, gonadotropin medication administration, and assessment of ovarian hyperstimulation syndrome (OHSS), followed by debriefing.\n\nImmediately after the first simulation, T2 assessments will be conducted, including anxiety, effective communication, self-efficacy, knowledge, and skill assessment. Four weeks later, participants will complete a second scenario-based hybrid simulation with the same learning objectives, followed by debriefing and the final T3 assessment.\n\nA preliminary application is planned with 6 nursing students to evaluate the feasibility of the educational content, simulation scenario, assessment instruments, and implementation process. These students will not be included in the main study. The main study is planned with 30 eligible nursing students.",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"Scenario-Based Hybrid Simulation","EXPERIMENTAL","Participants will receive six weeks of structured theoretical and video-based education followed by two scenario-based hybrid simulation sessions conducted four weeks apart. The simulations will involve a standardized female patient, a standardized male partner, and an injection model. Students will provide education regarding assisted reproductive treatment, gonadotropin medication administration, and ovarian hyperstimulation syndrome.",[41],"Behavioral: Scenario-Based Hybrid Simulation",[43],{"type":44,"name":37,"description":45,"armGroupLabels":46,"otherNames":27},"BEHAVIORAL","Participants will receive six weeks of structured theoretical and video-based education on assisted reproductive technologies and nursing, followed by two scenario-based hybrid simulation sessions conducted four weeks apart. Each simulation will involve a standardized female patient, a standardized male partner, and an injection model. Students will provide education on assisted reproductive treatment stages, the role of the male partner, gonadotropin medication administration, and risk factors and signs and symptoms of ovarian hyperstimulation syndrome. Each simulation will be followed by a structured debriefing session.",[37],[48,51],{"name":49,"affiliation":5,"role":50},"Hilal Karadeniz","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":5,"role":53},"Atiye Erbaş, PhD","STUDY_DIRECTOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":27,"email":59},"Hilal KARADENİZ, PhD","CONTACT","+90 0538 692 49 93","hilalkaradeniz1993@hotmail.com",{"type":61,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100658487","scenario-based-hybrid-simulation-for-patient-education-in-assisted-reproductive-treatment-100658487",false,"NCT07851155","Scenario-Based Hybrid Simulation for Patient Education in Assisted Reproductive Treatment","The Effect of a Scenario-Based Hybrid Simulation Aimed at Educating Patients Receiving Assisted Reproductive Treatment on Nursing Students' Anxiety, Effective Communication, Self-Efficacy, Knowledge, and Skills","Inclusion Criteria:\n\n* Being a third-year undergraduate nursing student.\n* Being enrolled in the Assisted Reproductive Technologies and Nursing course.\n* Voluntarily agreeing to participate in the study.\n* Having no previous experience with scenario-based or hybrid simulation training on assisted reproductive treatment.\n\nExclusion Criteria:\n\n* Not completing the simulation sessions.\n* Not completing any of the required data collection assessments.\n* Withdrawing from the study voluntarily.",true,"ALL",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[29],"This study aims to evaluate the effect of a scenario-based hybrid simulation designed for patient education in assisted reproductive treatment on nursing students' anxiety, effective communication, self-efficacy, knowledge, and skills. The study will include third-year nursing students enrolled in the Assisted Reproductive Technologies and Nursing course. Participants will receive six weeks of theoretical and video-based education followed by two scenario-based hybrid simulation sessions conducted four weeks apart. Outcomes will be assessed at four time points (T0, T1, T2, and T3). A preliminary application is planned with 6 students, followed by the main study with 30 students.",[78],"Assisted Reproductive Treatments",[80,81,82,83,84,85,86,87,88,89],"Assisted Reproductive Treatment","Nursing Students","Patient Education","Scenario-Based Simulation","Hybrid Simulation","Self-Efficacy","Anxiety","Effective Communication","Knowledge","Clinical Skills","NOT_YET_RECRUITING","2026-09-30",{"date":93,"type":94},"2026-10-01","ACTUAL",{"date":93,"type":73},{"date":97,"type":73},"2027-06-15",{"name":5,"class":6}]