Assisted Reproductive TreatmentsNCT07851155
Scenario-Based Hybrid Simulation for Patient Education in Assisted Reproductive Treatment
A study testing Scenario-Based Hybrid Simulation in people with Assisted Reproductive Treatments, run by Duzce University.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Assisted Reproductive Treatments
- What is being tested?
- Scenario-Based Hybrid Simulation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not completing the simulation sessions.
- Not completing any of the required data collection assessments.
- Withdrawing from the study voluntarily.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Assisted Reproductive Treatments
- Being tested
- Scenario-Based Hybrid Simulation
- Keywords
- Assisted Reproductive Treatment, Nursing Students, Patient Education, Scenario-Based Simulation, Hybrid Simulation, Self-Efficacy, Anxiety, Effective Communication, Knowledge, Clinical Skills
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scenario-Based Hybrid SimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Scenario-Based Hybrid Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (4)
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/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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TreatmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilal Karadeniz, Principal investigator, Duzce UniversityAtiye Erbaş, PhD, Study director, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851155
- Sponsor's protocol ID
- DUZCEU-ARTSIM-2026
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07851155
- Acronym / sponsor ID
- DUZCEU-ARTSIM-2026
- Conditions
- Assisted Reproductive Treatments
- Keywords
- Assisted Reproductive Treatment, Nursing Students, Patient Education, Scenario-Based Simulation, Hybrid Simulation, Self-Efficacy, Anxiety, Effective Communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Scenario-Based Hybrid Simulation | Experimental | Behavioral: Scenario-Based Hybrid SimulationParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Not completing the simulation sessions.
- Not completing any of the required data collection assessments.
- Withdrawing from the study voluntarily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scenario-Based Hybrid SimulationParticipants 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. | Behavioural | Scenario-Based Hybrid Simulation |
Primary outcome
Change in Assisted Reproductive Technologies Knowledge Score
Time frame: 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.
4 secondary outcomes
Change in Effective Communication Skills
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Validity and Reliability Study of Student Self-Efficacy Scale on Undergraduate Nursing StudentsLink provided by the sponsor.
- Effective Communication Skills: A New Conceptual Framework and Scale Development StudyLink provided by the sponsor.
- State-Trait Anxiety Inventory (STAI)Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilal Karadeniz principal investigator
Duzce University
Atiye Erbaş, PhD study director
Duzce University
Questions about this trial
What is this clinical trial studying?
A study testing Scenario-Based Hybrid Simulation in people with Assisted Reproductive Treatments, run by Duzce University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilal KARADENİZ, PhD (+90 0538 692 49 93, hilalkaradeniz1993@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Assisted Reproductive Technologies Knowledge Score (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.