- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Participants 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.
Immediately 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.
A 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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Hilal KARADENİZ, PhD
- Puhelinnumero: +90 0538 692 49 93
- Sähköposti: hilalkaradeniz1993@hotmail.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Being a third-year undergraduate nursing student.
- Being enrolled in the Assisted Reproductive Technologies and Nursing course.
- Voluntarily agreeing to participate in the study.
- Having no previous experience with scenario-based or hybrid simulation training on assisted reproductive treatment.
Exclusion Criteria:
- Not completing the simulation sessions.
- Not completing any of the required data collection assessments.
- Withdrawing from the study voluntarily.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Scenario-Based Hybrid Simulation
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. |
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Assisted Reproductive Technologies Knowledge Score
Aikaikkuna: 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).
|
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).
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Effective Communication Skills
Aikaikkuna: 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).
|
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/self-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/Self-disclosure, Empathy, and I-language sub-dimensions, respectively. |
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).
|
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Change in Anxiety Level
Aikaikkuna: 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).
|
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. |
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).
|
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Change in Self-Efficacy
Aikaikkuna: 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).
|
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. |
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).
|
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Change in Simulation Skill Performance
Aikaikkuna: 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.
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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.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Hilal Karadeniz, Duzce University
- Opintojohtaja: Atiye Erbaş, PhD, Duzce University
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DUZCEU-ARTSIM-2026
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Individual participant data will not be shared with other researchers because the study involves a relatively small group of nursing students from a single institution. Sharing individual-level data may increase the risk of participant identification and compromise confidentiality and privacy, particularly when combined with participants' demographic and academic characteristics. Therefore, individual participant data will be kept confidential and will not be made available for external research use.
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