Midwifery EducationNCT07078747
Video vs Model Training for Leopold Maneuver Skills
A study testing To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students. in people with Midwifery Education and Clinical Skills Training, run by Kahramanmaras Sutcu Imam University.
Trial summary
This randomized controlled study aims to compare the effectiveness of video-based and model-based training methods in improving Leopold maneuver skills among second-year midwifery students. The study will be conducted at the Faculty of Health Sciences, Kahramanmaraş Sütçü Imam University. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Midwifery Education, Clinical Skills Training
- What is being tested?
- To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 15 Apr 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be a second-year student in the Department of Midwifery at -Kahramanmaraş Sütçü Imam University, Faculty of Health Sciences
- Has not previously taken the "Normal Pregnancy and Care" course
- Has not received prior training on Leopold maneuvers
- Willing to voluntarily participate in the study
- Able to attend all training and assessment sessions during the study period
Who cannot join
- Having an acute health condition that may interfere with participation in the training
- Being on leave or having frozen enrollment during the study period
- Sharing study content or violating confidentiality with members of other groups
- Withdrawing from the study voluntarily or being excluded due to absenteeism
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: Comparison of Video- and Model-Based Training in Developing Leopold Maneuver Skills Among Midwifery Students: A Randomized Controlled Trial
This randomized controlled study aims to compare the effectiveness of video-based and model-based training methods in improving Leopold maneuver skills among second-year midwifery students. The study will be conducted at the Faculty of Health Sciences, Kahramanmaraş Sütçü Imam University. Eligible students will be randomly assigned into three groups: video-supported training, model-supported training, and control. All participants will first receive a 2-hour theoretical training session. Then, the video group will watch an instructional video, the model group will perform hands-on practice using anatomical models, and the control group will receive no additional intervention. Skill acquisition will be evaluated through practical assessments conducted a few days and two months after training. At the end of the study, compensatory training will be provided to all groups to ensure educational equity. Data collection tools include a psychomotor skills assessment form, a student satisfaction scale, and the Spielberger State Anxiety Inventory. Statistical analyses will be performed using SPSS software.
Read the detailed description
This randomized controlled trial investigates the comparative effectiveness of video-based and model-based educational interventions in enhancing second-year midwifery students' psychomotor skills related to the Leopold maneuvers. The study is designed with three parallel arms: (1) video-supported training, (2) anatomical model-supported training, and (3) control (no additional intervention beyond theoretical instruction).
A total of eligible participants will be recruited from the Faculty of Health Sciences at Kahramanmaraş Sütçü Imam University and randomly assigned to one of the three groups using block randomization to ensure balanced allocation. All participants will initially receive a standardized 2-hour face-to-face theoretical session on Leopold maneuvers, delivered by experienced faculty members using the same content.
Following the theoretical instruction:
The video group will view a professionally prepared instructional video demonstrating all four Leopold maneuvers.
The model group will engage in hands-on practice using standardized pregnant anatomical mannequins under supervision.
The control group will not receive any additional material or practice after the theoretical session.
Psychomotor skill acquisition will be measured using a structured and validated 25-item Leopold Maneuver Psychomotor Skills Assessment Form, scored on a 0-4 Likert scale per item, with a total score range of 0-100. Assessments will be conducted at two time points: (1) within a few days following the intervention (to assess immediate skill gain), and (2) two months post-intervention (to assess skill retention).
To address potential ethical concerns and ensure educational equity, compensatory training (video + model-based) will be offered to all groups after final assessments are completed.
Additional data collection tools include:
A Student Satisfaction Scale designed for evaluating the learner experience with the instructional method,
The Spielberger State Anxiety Inventory (STAI-S) to assess state anxiety levels during skills application phases.
All statistical analyses will be conducted using SPSS version XX (or equivalent), employing appropriate tests for intergroup comparisons (e.g., ANOVA, repeated measures ANOVA) and within-group changes (e.g., paired t-tests or non-parametric equivalents depending on distribution). A p-value < 0.05 will be considered statistically significant.
The study adheres to ethical guidelines for human subject research and has obtained approval from the relevant Institutional Ethics Committee. Participation is voluntary and written informed consent will be obtained from all students prior to enrollment.
- Conditions
- Midwifery Education, Clinical Skills Training
- Being tested
- To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.Behavioural
This study involves two educational interventions aimed at improving Leopold maneuver skills among midwifery students. Both intervention groups receive a standardized 2-hour theoretical lecture about the purpose, application, and clinical relevance of the Leopold maneuvers.
In the Video-Based Training Group, students watch an instructional video developed by the research team that visually demonstrates each step of the maneuver.
In the Model-Based Training Group, students perform the maneuvers on anatomical models under the supervision of an instructor.
These interventions are conducted in separate sessions to prevent cross-group contamination.
| Study group | Role | What they receive |
|---|---|---|
| Model-Based Training Group | Experimental | Participants in this group will receive the same 2-hour theoretical education, followed by hands-on practice of Leopold maneuvers on anatomical models under researcher supervision. Receives: Behavioral: To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students. |
| Video-Based Training Group | Experimental | Participants in this group will receive a 2-hour theoretical education on Leopold maneuvers followed by video-based training using an instructional video. Training is conducted in a skills lab environment. Receives: Behavioral: To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students. |
| Control Group | No intervention | Participants in this group will only receive the 2-hour theoretical training. No additional practical training will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Skill Score in Leopold Maneuver Application
The primary outcome is the change in psychomotor skill scores measured by the Leopold Maneuver Psychomotor Skill Assessment Form. This validated tool consists of 25 observable items scored on a 5-point Likert scale (0-4), with a total score range of 0-100. Higher scores indicate greater proficiency in performing the Leopold maneuvers.
Measured: Assessed within 1 week after training and again at 8 weeks after training
Secondary outcomes (2)
Student Satisfaction with Training Method
Student satisfaction will be measured using a custom 6-point Likert scale ranging from 0 (not satisfied) to 5 (very satisfied), indicating the participant's perceived satisfaction with the instructional method used (video or model-based).
Measured: Assessed within 1 week after training and again at 8 weeks after training
State Anxiety Level
Anxiety will be assessed using the Spielberger State Anxiety Inventory (SAI), which includes 20 items rated on a 4-point Likert scale. Scores range from 20 to 80, with higher scores indicating greater anxiety.
Measured: Assessed within 1 week after training and again at 8 weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Midwifery EducationStudies 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
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Akyıldız, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078747
- Sponsor's protocol ID
- Leopold Training
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 24 Jul 2025
- 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 due to institutional policies and data privacy concerns.
Publications
Opoku A, Usman MB, Adjei TA, Owusu-Afriyie B, Opoku W. Nursing and midwifery students' perceptions of sign language training in Ghana: relevance, instructional methods, and assessment practices. BMC Nurs. 2025 Jul 18;24(1):942. doi: 10.1186/s12912-025-03610-y.
PubMed 40682143Bowers M, Terry D, Irwin P. The impact of reflective practice on nursing students: a scoping review. Nurse Educ Pract. 2025 Aug;87:104468. doi: 10.1016/j.nepr.2025.104468. Epub 2025 Jul 13.
PubMed 40683080
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video- and Model-Based Training in Developing Leopold Maneuver Skills Among Midwifery Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07078747
- Acronym / sponsor ID
- Leopold Training
- Conditions
- Midwifery Education, Clinical Skills Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 22 Jul 2025 (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 randomized controlled study aims to compare the effectiveness of video-based and model-based training methods in improving Leopold maneuver skills among second-year midwifery students. The study will be conducted at the Faculty of Health Sciences, Kahramanmaraş Sütçü Imam University. Eligible students will be randomly assigned into three groups: video-supported training, model-supported training, and control. All participants will first receive a 2-hour theoretical training session. Then, the video group will watch an instructional video, the model group will perform hands-on practice using anatomical models, and the control group will receive no additional intervention. Skill acquisition will be evaluated through practical assessments conducted a few days and two months after training. At the end of the study, compensatory training will be provided to all groups to ensure educational equity. Data collection tools include a psychomotor skills assessment form, a student satisfaction scale, and the Spielberger State Anxiety Inventory. Statistical analyses will be performed using SPSS software.
Detailed description
This randomized controlled trial investigates the comparative effectiveness of video-based and model-based educational interventions in enhancing second-year midwifery students' psychomotor skills related to the Leopold maneuvers. The study is designed with three parallel arms: (1) video-supported training, (2) anatomical model-supported training, and (3) control (no additional intervention beyond theoretical instruction).
A total of eligible participants will be recruited from the Faculty of Health Sciences at Kahramanmaraş Sütçü Imam University and randomly assigned to one of the three groups using block randomization to ensure balanced allocation. All participants will initially receive a standardized 2-hour face-to-face theoretical session on Leopold maneuvers, delivered by experienced faculty members using the same content.
Following the theoretical instruction:
The video group will view a professionally prepared instructional video demonstrating all four Leopold maneuvers.
The model group will engage in hands-on practice using standardized pregnant anatomical mannequins under supervision.
The control group will not receive any additional material or practice after the theoretical session.
Psychomotor skill acquisition will be measured using a structured and validated 25-item Leopold Maneuver Psychomotor Skills Assessment Form, scored on a 0-4 Likert scale per item, with a total score range of 0-100. Assessments will be conducted at two time points: (1) within a few days following the intervention (to assess immediate skill gain), and (2) two months post-intervention (to assess skill retention).
To address potential ethical concerns and ensure educational equity, compensatory training (video + model-based) will be offered to all groups after final assessments are completed.
Additional data collection tools include:
A Student Satisfaction Scale designed for evaluating the learner experience with the instructional method,
The Spielberger State Anxiety Inventory (STAI-S) to assess state anxiety levels during skills application phases.
All statistical analyses will be conducted using SPSS version XX (or equivalent), employing appropriate tests for intergroup comparisons (e.g., ANOVA, repeated measures ANOVA) and within-group changes (e.g., paired t-tests or non-parametric equivalents depending on distribution). A p-value < 0.05 will be considered statistically significant.
The study adheres to ethical guidelines for human subject research and has obtained approval from the relevant Institutional Ethics Committee. Participation is voluntary and written informed consent will be obtained from all students prior to enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Model-Based Training Group | Experimental | Behavioral: To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.Participants in this group will receive the same 2-hour theoretical education, followed by hands-on practice of Leopold maneuvers on anatomical models under researcher supervision. |
| Video-Based Training Group | Experimental | Behavioral: To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.Participants in this group will receive a 2-hour theoretical education on Leopold maneuvers followed by video-based training using an instructional video. Training is conducted in a skills lab environment. |
| Control Group | No intervention | –Participants in this group will only receive the 2-hour theoretical training. No additional practical training will be provided. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must be a second-year student in the Department of Midwifery at -Kahramanmaraş Sütçü Imam University, Faculty of Health Sciences
- Has not previously taken the "Normal Pregnancy and Care" course
- Has not received prior training on Leopold maneuvers
- Willing to voluntarily participate in the study
- Able to attend all training and assessment sessions during the study period
Key exclusion criteria (4 listed)
- Having an acute health condition that may interfere with participation in the training
- Being on leave or having frozen enrollment during the study period
- Sharing study content or violating confidentiality with members of other groups
- Withdrawing from the study voluntarily or being excluded due to absenteeism
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 |
|---|---|---|
| To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.This study involves two educational interventions aimed at improving Leopold maneuver skills among midwifery students. Both intervention groups receive a standardized 2-hour theoretical lecture about the purpose, application, and clinical relevance of the Leopold maneuvers. In the Video-Based Training Group, students watch an instructional video developed by the research team that visually demonstrates each step of the maneuver. In the Model-Based Training Group, students perform the maneuvers on anatomical models under the supervision of an instructor. These interventions are conducted in separate sessions to prevent cross-group contamination. | Behavioural | Model-Based Training Group, Video-Based Training Group |
Primary outcome
Psychomotor Skill Score in Leopold Maneuver Application
Time frame: Assessed within 1 week after training and again at 8 weeks after training
The primary outcome is the change in psychomotor skill scores measured by the Leopold Maneuver Psychomotor Skill Assessment Form. This validated tool consists of 25 observable items scored on a 5-point Likert scale (0-4), with a total score range of 0-100. Higher scores indicate greater proficiency in performing the Leopold maneuvers.
2 secondary outcomes
Student Satisfaction with Training Method
Time frame: Assessed within 1 week after training and again at 8 weeks after training
State Anxiety Level
Time frame: Assessed within 1 week after training and again at 8 weeks after training
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 24 Jul 2025.
- Background: PubMed 40682143Opoku A, Usman MB, Adjei TA, Owusu-Afriyie B, Opoku W. Nursing and midwifery students' perceptions of sign language training in Ghana: relevance, instructional methods, and assessment practices. BMC Nurs. 2025 Jul 18;24(1):942. doi: 10.1186/s12912-025-03610-y.
- Background: PubMed 40683080Bowers M, Terry D, Irwin P. The impact of reflective practice on nursing students: a scoping review. Nurse Educ Pract. 2025 Aug;87:104468. doi: 10.1016/j.nepr.2025.104468. Epub 2025 Jul 13.
- Background This randomized controlled trial evaluated the outcomes of simulation- and video-based training for teaching nursing students Leopold's maneuver. Their self-efficacy and anxiety levels were also explored. Method Data were collected among 12Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and data privacy concerns.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students. in people with Midwifery Education and Clinical Skills Training, run by Kahramanmaras Sutcu Imam 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 5 inclusion and 4 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 24 Jul 2025. 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 Deniz Akyıldız, PhD (+905069851358, denizbtm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor Skill Score in Leopold Maneuver Application (time frame: Assessed within 1 week after training and again at 8 weeks after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07078747, which also lists 2 linked publications.
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 24 Jul 2025.