Clinical Skills TrainingNCT07848724
Low-Fidelity Simulation Training for Leopold Maneuvers in Midwifery Students
A study testing Low-Fidelity Simulation-Based Practice and Standard Classroom Training in people with Clinical Skills Training and Midwifery Education, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether adding hands-on practice with a low-fidelity simulation model to standard classroom instruction improves second-year midwifery students' knowledge, clinical performance, and self-confidence in performing Leopold's maneuvers, compared with standard instruction alone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Skills Training, Midwifery Education
- What is being tested?
- Low-Fidelity Simulation-Based Practice and Standard Classroom Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2026to 25 Dec 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
- Second-year midwifery student
- Enrolled in the Obstetrics I course for the first time
- Able to speak and understand Turkish
- 18 years of age or older
- Provides written informed consent
Who cannot join
- First-, third-, or fourth-year midwifery student
- Repeating the Obstetrics I course due to failure or grade improvement
- Does not provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Low-Fidelity Simulation-Based Leopold Maneuvers Training on Midwifery Students' Knowledge and Skill Levels: A Randomized Controlled Trial
This study evaluates whether adding hands-on practice with a low-fidelity simulation model to standard classroom instruction improves second-year midwifery students' knowledge, clinical performance, and self-confidence in performing Leopold's maneuvers, compared with standard instruction alone. Participants will be randomly assigned to a simulation group or a control group. Knowledge and skill are assessed immediately after training and again 28 days later to evaluate retention.
Read the detailed description
Leopold's maneuvers are a core, non-invasive clinical assessment skill in midwifery practice, used from approximately the 24th week of pregnancy to determine fetal lie, presentation, and engagement. Prior randomized trials have examined simulation-based approaches to teaching this specific skill.
This trial is designed to extend that literature in four specific ways: (1) rather than comparing simulation and video as separate, competing modalities, this trial uses a two-arm additive design in which both groups receive the same standard curriculum, including video instruction, and only the experimental group receives simulation-based practice on top of it - testing whether hands-on simulation adds value once video-based instruction is already standard practice, which is arguably the more directly practice-relevant question; (2) it adds a purpose-built, content-validated 20-item multiple-choice knowledge test alongside the skill and confidence/satisfaction measures, so cognitive, psychomotor, and affective outcomes are captured within a single design; (3) it includes a 28-day follow-up assessment of knowledge and skill to evaluate retention, (4) the sample size is prospectively determined by an a priori power analysis, with the effect-size assumption grounded in observed effect sizes from the closest comparable trial. For ethical equity, control-group participants receive the simulation-based training after their own 28 days later assessment is complete.
- Conditions
- Clinical Skills Training, Midwifery Education
- Being tested
- Low-Fidelity Simulation-Based Practice, Standard Classroom Training
- Keywords
- Leopold's maneuvers, midwifery students, simulation-based education, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Fidelity Simulation-Based PracticeBehavioural
Arm 1 only (Simulation-Based Training Group)
Standard Classroom TrainingBehavioural
Both arms
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Simulation-Based Training Group: Standard theoretical training (50-minute slide presentation and instructional video) plus hands-on practice of the four Leopold maneuvers on a low-fidelity abdominal palpation simulation model, in small groups of 5-7 students under researcher supervision (30 minutes), delivered once. Receives: Behavioral: Low-Fidelity Simulation-Based Practice; Behavioral: Standard Classroom Training |
| Active Comparator | Active comparator | Active Comparator: Standard Training Group (Control). Standard theoretical training only (50-minute slide presentation and instructional video). After completing their own 28 days later assessments, these participants also receive the simulation-based training described above, for ethical equity. Receives: Behavioral: Standard Classroom Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Leopold Maneuver Application Skill Score
Structured, researcher-administered checklist scoring correct performance of each procedural step of the Leopold maneuvers (0 = not performed, 1 = partially performed, 2 = correctly performed); total score range 0-40, higher score = better skill performance. Content validity will be established using the Lawshe technique with at least 5 subject-matter experts. Administered immediately after training and again 28 days later to allow within-subject calculation of retention. Assessors are blinded to group assignment. At each assessment, a random ~25% subsample of each group is scored simultaneously and independently by a second rater who is not the participant's primary assessor; inter-rater reliability is calculated and reported.
Measured: Immediately after training completion, and 28 days after training completion
Change in Leopold Maneuvers Knowledge Score
A 20-item multiple-choice knowledge test developed by the researchers based on a review of the literature, covering the procedural steps of the Leopold maneuvers, their purpose, and interpretation of the findings obtained. One point is given for each correct answer and zero points for each incorrect answer; total score ranges from 0 (minimum) to 20 (maximum), with higher scores indicating greater knowledge. Content validity will be established using the Lawshe technique with at least 5 subject-matter experts, followed by a pilot test with 10 students outside the study sample.
Measured: Baseline (before training), immediately after training completion, and 28 days after training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start2 Oct 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Skills TrainingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial uses a two-arm parallel design (Experimental and Control groups), with outcome assessments conducted at baseline, immediately after training, and 28 days after training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Karaman, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848724
- Sponsor's protocol ID
- SKaraman
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Fidelity Simulation-Based Leopold Maneuvers Training on Midwifery Students' Knowledge and Skill Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07848724
- Acronym / sponsor ID
- SKaraman
- Conditions
- Clinical Skills Training, Midwifery Education
- Keywords
- Leopold's maneuvers, midwifery students, simulation-based education, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 30 Sep 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 evaluates whether adding hands-on practice with a low-fidelity simulation model to standard classroom instruction improves second-year midwifery students' knowledge, clinical performance, and self-confidence in performing Leopold's maneuvers, compared with standard instruction alone. Participants will be randomly assigned to a simulation group or a control group. Knowledge and skill are assessed immediately after training and again 28 days later to evaluate retention.
Detailed description
Leopold's maneuvers are a core, non-invasive clinical assessment skill in midwifery practice, used from approximately the 24th week of pregnancy to determine fetal lie, presentation, and engagement. Prior randomized trials have examined simulation-based approaches to teaching this specific skill.
This trial is designed to extend that literature in four specific ways: (1) rather than comparing simulation and video as separate, competing modalities, this trial uses a two-arm additive design in which both groups receive the same standard curriculum, including video instruction, and only the experimental group receives simulation-based practice on top of it - testing whether hands-on simulation adds value once video-based instruction is already standard practice, which is arguably the more directly practice-relevant question; (2) it adds a purpose-built, content-validated 20-item multiple-choice knowledge test alongside the skill and confidence/satisfaction measures, so cognitive, psychomotor, and affective outcomes are captured within a single design; (3) it includes a 28-day follow-up assessment of knowledge and skill to evaluate retention, (4) the sample size is prospectively determined by an a priori power analysis, with the effect-size assumption grounded in observed effect sizes from the closest comparable trial. For ethical equity, control-group participants receive the simulation-based training after their own 28 days later assessment is complete.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled trial uses a two-arm parallel design (Experimental and Control groups), with outcome assessments conducted at baseline, immediately after training, and 28 days after training.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Low-Fidelity Simulation-Based Practice, Behavioral: Standard Classroom TrainingSimulation-Based Training Group: Standard theoretical training (50-minute slide presentation and instructional video) plus hands-on practice of the four Leopold maneuvers on a low-fidelity abdominal palpation simulation model, in small groups of 5-7 students under researcher supervision (30 minutes), delivered once. |
| Active Comparator | Active comparator | Behavioral: Standard Classroom TrainingActive Comparator: Standard Training Group (Control). Standard theoretical training only (50-minute slide presentation and instructional video). After completing their own 28 days later assessments, these participants also receive the simulation-based training described above, for ethical equity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Second-year midwifery student
- Enrolled in the Obstetrics I course for the first time
- Able to speak and understand Turkish
- 18 years of age or older
- Provides written informed consent
Key exclusion criteria (3 listed)
- First-, third-, or fourth-year midwifery student
- Repeating the Obstetrics I course due to failure or grade improvement
- Does not provide informed consent
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 |
|---|---|---|
| Low-Fidelity Simulation-Based PracticeArm 1 only (Simulation-Based Training Group) | Behavioural | Experimental |
| Standard Classroom TrainingBoth arms | Behavioural | Active Comparator, Experimental |
Primary outcome
Change in Leopold Maneuver Application Skill Score
Time frame: Immediately after training completion, and 28 days after training completion
Structured, researcher-administered checklist scoring correct performance of each procedural step of the Leopold maneuvers (0 = not performed, 1 = partially performed, 2 = correctly performed); total score range 0-40, higher score = better skill performance. Content validity will be established using the Lawshe technique with at least 5 subject-matter experts. Administered immediately after training and again 28 days later to allow within-subject calculation of retention. Assessors are blinded to group assignment. At each assessment, a random ~25% subsample of each group is scored simultaneously and independently by a second rater who is not the participant's primary assessor; inter-rater reliability is calculated and reported.
Change in Leopold Maneuvers Knowledge Score
Time frame: Baseline (before training), immediately after training completion, and 28 days after training completion
A 20-item multiple-choice knowledge test developed by the researchers based on a review of the literature, covering the procedural steps of the Leopold maneuvers, their purpose, and interpretation of the findings obtained. One point is given for each correct answer and zero points for each incorrect answer; total score ranges from 0 (minimum) to 20 (maximum), with higher scores indicating greater knowledge. Content validity will be established using the Lawshe technique with at least 5 subject-matter experts, followed by a pilot test with 10 students outside the study sample.
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 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Clinical Skills Training
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Not yet recruiting
Effects of EbeCast Digital Learning on Midwifery Students' Women's Health Skills
Midwifery Education, Clinical Skills Training
Recruiting
Peripheral Venous Access Management by Radiologic Technologists in Radiodiagnostic Procedure
Skill Development of Staff, Clinical Practice
Recruiting
Video-Based Self-Assessment in Neonatal Resuscitation Training
Neonatal Resuscitation, Simulation-Based Education
Not yet recruiting
Web-Based Gamified Simulation for Teaching Ventrogluteal Injection to First-Year Nursing Students
Nursing Education, Intramuscular Injection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Fidelity Simulation-Based Practice and Standard Classroom Training in people with Clinical Skills Training and Midwifery Education, run by Kırklareli University at 1 site in Turkey (Türkiye).
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 5 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: enrolling by invitation, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Leopold Maneuver Application Skill Score (time frame: Immediately after training completion, and 28 days after training completion). The study lists 2 primary outcomes in all. 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 30 Sep 2026.