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Scenario-Based Hybrid Simulation for Patient Education in Assisted Reproductive Treatment

30 de septiembre de 2026 actualizado por: Duzce University

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.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Assisted Reproductive Technologies Knowledge Score
Periodo de tiempo: 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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Effective Communication Skills
Periodo de tiempo: 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).
Change in Anxiety Level
Periodo de tiempo: 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).
Change in Self-Efficacy
Periodo de tiempo: 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).
Change in Simulation Skill Performance
Periodo de tiempo: 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.

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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Hilal Karadeniz, Duzce University
  • Director de estudio: Atiye Erbaş, PhD, Duzce University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

15 de enero de 2027

Finalización del estudio (Estimado)

15 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

23 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Publicado por primera vez (Actual)

1 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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