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Student NursingNCT07747051

The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance

A study testing Participants completed the pretest, received a scenario-based pregnancy nutrition counseling simulation, and then completed the posttest and clinical skill assessment. in people with Student Nursing and Simulation Training, run by Ayşenur Karakuş.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance: A Randomized Controlled Trial Research Hypotheses H1: Scenario-based simulation training significantly reduces anxiety levels… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Participants completed the pretest, received a scenario-based pregnancy nutrition counseling simulation, and then completed the posttest and clinical skill assessment.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
9 Jul 2026to 9 Aug 2026
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Undergraduate nursing students enrolled in the Department of Nursing.
  • Willingness to participate in the study and provision of written informed consent.
  • No previous participation in scenario-based simulation training on pregnancy nutrition counseling or a similar topic.

Who cannot join

  • Failure to attend the intervention or complete the study procedures.
  • Incomplete completion of the pretest or posttest questionnaires.
  • Withdrawal from the study at any stage

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ayşenur Karakuş, MSc contact

+905350551604

aysenurkaraakus@gmail.com

Burcu Küçükkaya, PhD contact

+905422931357

burcukucukkaya1992@gmail.com

About this study

Official title: The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance: A Randomized Controlled Trial

The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance: A Randomized Controlled Trial

Research Hypotheses

Read more

H1: Scenario-based simulation training significantly reduces anxiety levels among nursing students.

H2: Scenario-based simulation training significantly increases nursing students' perceived self-efficacy.

H3: Scenario-based simulation training significantly improves nursing students' clinical skill performance.

H0₁: Scenario-based simulation training has no statistically significant effect on nursing students' anxiety levels.

H0₂: Scenario-based simulation training has no statistically significant effect on nursing students' perceived self-efficacy.

H0₃: Scenario-based simulation training has no statistically significant effect on nursing students' clinical skill performance.

Read the detailed description

Participants and Sampling The study population consisted of undergraduate nursing students enrolled in the Faculty of Health Sciences, Department of Nursing, at Eskişehir Osmangazi University. The study sample comprised 52 nursing students who agreed to participate during the study period and met the eligibility criteria. Participants were randomly assigned to either the intervention group (n = 26) or the control group (n = 26) using a simple randomization procedure.

The required sample size was determined using G*Power software (version 3.1.9.7). The calculation was based on a moderate-to-large effect size (d = 0.70), a significance level of α = .05, and a statistical power of 0.80. The analysis indicated that a minimum of 23 participants per group was required. Considering the possibility of missing data and participant attrition, the sample size was increased to 26 students per group.

Purposive sampling, a non-probability sampling method, was employed to recruit participants. This sampling strategy was selected to ensure the inclusion of nursing students who had received theoretical instruction in pregnancy nutrition counseling and were eligible to participate in the simulation-based educational intervention.

Eligible participants were undergraduate nursing students who voluntarily agreed to participate in the study and had not previously received simulation training on a similar topic. Students who failed to participate throughout the study or who submitted incomplete pretest or posttest questionnaires were excluded from the analysis.

Randomization and Blinding Participants were allocated to the intervention and control groups using a simple randomization procedure. After eligible and consenting students had been assigned identification numbers, a computer-generated random number sequence was used to allocate participants to either the intervention group (n = 26) or the control group (n = 26). The randomization process was performed by an independent researcher who was not directly involved in the study.

To ensure allocation concealment, group assignments were placed in sequentially numbered, sealed, opaque envelopes. As each participant was enrolled, the corresponding envelope was opened to determine group assignment.

Because of the nature of the educational intervention, blinding of participants and instructors was not feasible. Therefore, the study was designed as a single-blind randomized controlled trial. Outcome assessment was performed by independent assessors who were unaware of participants' group allocation using a standardized clinical skills checklist. Data analysts were also blinded to group allocation by coding the study groups.

Data Collection Procedure Data collection was initiated after obtaining ethical approval and institutional permission and was conducted in three sequential phases: (1) pretest assessment, (2) scenario-based simulation training, and (3) posttest assessment and clinical skill evaluation.

After written informed consent had been obtained, baseline data on participants' anxiety levels and perceived self-efficacy were collected using the pretest instruments.

Participants in the intervention group then completed a researcher-developed scenario-based simulation program on pregnancy nutrition counseling. The simulation replicated an outpatient clinic setting, and each simulation session lasted approximately 20 minutes.

Immediately after the simulation, participants attended a structured debriefing session lasting approximately 20 minutes to reflect on their clinical experiences, identify strengths, and discuss areas for improvement. Following the debriefing session, participants completed the posttest instruments. Clinical skill performance was subsequently evaluated using the Pregnancy Nutrition Counseling Skills Checklist developed by the researchers.

Data Collection Tools The study data were collected using the Participant Information Form, the State Anxiety Inventory (SAI), the Beck Anxiety Inventory (BAI), the Nursing Learning Self-Efficacy Scale (NLSES), and the Pregnancy Nutrition Counseling Skills Checklist.

Participant Information Form The Participant Information Form was developed by the researchers based on the relevant literature to obtain participants' sociodemographic characteristics, academic characteristics, clinical experience, and previous simulation experience. The form consists of 15 items.

State Anxiety Inventory (SAI) The State Anxiety Inventory (SAI) was used to assess participants' state anxiety levels. The original instrument consists of two 20-item subscales measuring state and trait anxiety; however, only the State Anxiety Inventory was used in the present study. Each item is rated on a four-point Likert scale ranging from 1 ("Not at all") to 4 ("Very much so"). Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety. The Cronbach's alpha coefficient of the scale in the present study was 0.966.

Beck Anxiety Inventory (BAI) The Beck Anxiety Inventory (BAI) was used to evaluate the severity of anxiety symptoms experienced during the previous week. The instrument consists of 21 self-report items scored on a four-point scale (0-3), yielding total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity.

Total scores are interpreted as follows:

0-7: Minimal anxiety 8-15: Mild anxiety 16-25: Moderate anxiety 26-63: Severe anxiety The Cronbach's alpha coefficient of the Beck Anxiety Inventory in the present study was 0.962.

Nursing Learning Self-Efficacy Scale The Nursing Learning Self-Efficacy Scale (NLSES) was used to evaluate nursing students' perceived self-efficacy regarding learning and clinical practice.The original scale consists of 21 items and five subdimensions: conceptual understanding, higher-order cognitive skills, practical work, everyday application, and nursing communication. In the Turkish adaptation, one item was removed, and the practical work and everyday application subdimensions were merged, resulting in a 20-item scale with four subdimensions: conceptual understanding, higher-order cognitive skills, nursing communication, and everyday practical applications.The Cronbach's alpha coefficient of the scale in the present study was 0.993.

Pregnancy Nutrition Counseling Skills Checklist Students' clinical skill performance was evaluated using the Pregnancy Nutrition Counseling Skills Checklist developed by the researchers. The checklist consists of 18 items covering therapeutic communication, history taking, assessment of maternal nutritional status, identification of gestational diabetes mellitus risk factors, development of individualized nutrition counseling plans, application of motivational interviewing techniques, patient education, and follow-up planning. Each item is rated as "Performed," "Partially Performed," or "Not Performed," providing a standardized assessment of students' clinical performance during the simulation. The checklist demonstrated excellent internal consistency in the present study, with a Cronbach's alpha coefficient of 0.989.

Being tested
Participants completed the pretest, received a scenario-based pregnancy nutrition counseling simulation, and then completed the posttest and clinical skill assessment.
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Participants completed the pretest, received a scenario-based pregnancy nutrition counseling simulation, and then completed the posttest and clinical skill assessment.Behavioural

    Participants in the intervention group received a researcher-developed scenario-based simulation on pregnancy nutrition counseling in a simulated outpatient clinic setting. The intervention consisted of a 20-minute simulation session followed by a 20-minute structured debriefing facilitated by the researchers. Clinical skill performance was evaluated using a standardized skills checklist.

Study groups in NCT07747051
Study groupRoleWhat they receive
ExperimentalExperimentalData collection was conducted after obtaining ethical approval and institutional permission. Participants were informed about the study and provided written informed consent before completing the pretest assessing anxiety and perceived self-efficacy. Following the pretest, participants in the intervention group received a 20-minute scenario-based simulation training on pregnancy nutrition counseling, designed to simulate an outpatient clinic setting. This was followed by a 20-minute structured debriefing session facilitated by the researchers. After the intervention, participants completed the posttest to evaluate changes in anxiety and perceived self-efficacy. Clinical skill performance was assessed using the Pregnancy Nutrition Counseling Skills Checklist developed by the researchers.
Receives: Behavioral: Participants completed the pretest, received a scenario-based pregnancy nutrition counseling simulation, and then completed the posttest and clinical skill assessment.
ControlNo interventionThe control group received the standard theoretical education on pregnancy nutrition counseling routinely provided in the nursing curriculum and did not participate in the scenario-based simulation training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Skill Performance

    Clinical skill performance will be evaluated using the Pregnancy Nutrition Counseling Skills Checklist, an 18-item instrument developed by the researchers based on the relevant literature. The checklist assesses students' competency in providing pregnancy nutrition counseling, including therapeutic communication, history taking, assessment of maternal nutritional status, identification of gestational diabetes mellitus (GDM) risk factors, development of individualized nutrition counseling plans, application of motivational interviewing techniques, patient education, and follow-up planning. Each item is rated as "Performed," "Partially Performed," or "Not Performed." Students are expected to demonstrate these competencies while managing a standardized pregnancy nutrition counseling scenario. Total clinical skill performance scores obtained after the intervention will be compared between the intervention and control groups, with higher scores indicating better clinical performance.

    Measured: Immediately after the intervention

Secondary outcomes (2)
  1. Change in State Anxiety Level

    Anxiety will be assessed using the State Anxiety Inventory (SAI) and the Beck Anxiety Inventory (BAI). The 20-item SAI measures current state anxiety (score range: 20-80), with higher scores indicating greater anxiety. The 21-item BAI assesses the severity of anxiety symptoms experienced during the previous week (score range: 0-63), classified as minimal (0-7), mild (8-15), moderate (16-25), or severe (26-63). Both instruments will be administered immediately before and after the intervention. Pretest scores will establish baseline anxiety levels, while posttest scores will evaluate changes following the intervention. Reductions in SAI and BAI scores will indicate improved anxiety outcomes. Score changes will be compared between the intervention and control groups to evaluate the effectiveness of the scenario-based simulation training.

    Measured: Immediately before and immediately after the intervention

  2. Change in Perceived Self-Efficacy

    Perceived self-efficacy will be assessed using the Nursing Learning Self-Efficacy Scale. The scale consists of 21 items across five domains: conceptual understanding, higher-order cognitive skills, practical work, everyday application, and nursing communication. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total scores range from 21 to 105, with lower scores indicating lower perceived self-efficacy and higher scores indicating greater perceived self-efficacy in nursing learning. The Turkish version demonstrated excellent content validity (language CVI = 0.95; content CVI = 0.92) and high internal consistency (Cronbach's α = 0.95). In the present study, the Cronbach's α coefficient was 0.993. Participants will complete the scale before and after the intervention. Changes in mean scores will be compared between the intervention and control groups.

    Measured: Immediately before and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2026
  2. Study start9 Jul 2026 (estimated)
  3. Primary completion9 Aug 2026 (estimated)
  4. Study completion9 Aug 2026 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07747051
Sponsor's protocol ID
2026-SBB-0446
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Participants completed the pretest, received a scenario-based pregnancy nutrition counseling simulation, and then completed the posttest and clinical skill assessment. in people with Student Nursing and Simulation Training, run by Ayşenur Karakuş.

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 3 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 5 Aug 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 Ayşenur Karakuş, MSc (+905350551604, aysenurkaraakus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Skill Performance (time frame: Immediately after the intervention). 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 5 Aug 2026.

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