Shoulder Dystocia - DeliveredNCT06105268
Management of Shoulder Dystocia in Flipped Learning
A study testing flipped learning training group in people with Shoulder Dystocia - Delivered, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Flipped learning is an innovative learning method in midwifery education. Studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia - Delivered
- What is being tested?
- flipped learning training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Agreeing to participate in the study,
- Being a 4th year student at the Department of Midwifery,
Who cannot join
- - Refusing to participate in the study,
- Being a 1st, 2nd and 3rd year student in the midwifery department
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Reyhan Aydin Doğan
Karabük, Karabük Province, 78500
About this study
Official title: The Effect of a Flipped Learning Approach on Midwifery Students Learning Shoulder Dystocia Management: A Randomized Controlled Trial.
Flipped learning is an innovative learning method in midwifery education. Studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. For this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education.
Read the detailed description
Flipped learning is an innovative learning method in midwifery education. Studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. For this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education.
Hypotheses of the research;
First Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' shoulder dystocia knowledge levels.
Second Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' levels of Student Satisfaction and Self-Confidence in Learning.
Third Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' Pagana Clinical Stress levels.
- Conditions
- Shoulder Dystocia - Delivered
- Being tested
- flipped learning training group
- Keywords
- Shoulder Dystocia, flipped learning, midwifery student
- Medical subject headings
- Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flipped learning training groupOther
flipped learning training group. Applying a flipped learning model in addition to routine training in a fully equipped simulation
| Study group | Role | What they receive |
|---|---|---|
| flipped learning group | Experimental | In addition to the traditional theory training to be given within the scope of the study, two hours of video-supported shoulder dystocia training will be given using the university's corporate Microsoft teams program, one day before the simulation application. The videos used in the training consist of previously shot training videos. There is no copyright or legal problem in using the videos. Receives: Other: flipped learning training group |
| routine training group- control group | No intervention | The control group will be given shoulder dystocia theory training before the simulation training within the routine course protocol within the scope of the routine risky birth and postpartum period course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
H1
Using the flipped learning model in midwifery education increases the knowledge level score of midwifery students on shoulder dystocia.
Measured: 12 months
H1
Using the flipped learning model in midwifery education reduces the PANAGA clinical stress level score of midwifery students.
Measured: 12 months
H1
Using the flipped learning model in midwifery education increases midwifery students' oStudent Satisfaction and Self-Confidence in Learning Scale scores.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start6 Jun 2024
- Primary completion10 Jun 2024
- Study completion30 Jun 2025
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 Shoulder Dystocia - DeliveredStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample of the study will consist of two groups: experimental and control. The number of students in each group is the difference between the experimental and control groups in order to determine the effectiveness of shoulder dystocia management given using the flipped learning technique; With 95% confidence (1-α), 95% test power (1-β), d = 1.3000000 effect size and two-sided t test, the number of samples to be taken in each group will be 17 and the study should be conducted with a total of 34 students (16). . Since there is no case of data loss and there is no sample study where the flipped learning technique and shoulder dystocia are used together, a total of 68 students will be studied, 34 students in each group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Aydin Doğan, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105268
- Sponsor's protocol ID
- 2022/1141
- Status last verified
- Jan 2025
- First submitted
- 16 Oct 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be shared when the work is completed.
Publications
Saritas E, Baykara ZG. The effect of flipped learning approach on nursing students' learning of patient safety: A randomized controlled trial. Nurse Educ Pract. 2023 Oct;72:103742. doi: 10.1016/j.nepr.2023.103742. Epub 2023 Aug 10.
PubMed 37611355Golaki SP, Kamali F, Bagherzadeh R, Hajinejad F, Vahedparast H. The effect of Flipped Classroom through Near Peer Education (FC through NPE) on patient safety knowledge retention in nursing and midwifery students: a solomon four-group design. BMC Med Educ. 2022 Feb 19;22(1):112. doi: 10.1186/s12909-022-03144-w.
PubMed 35183160
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Flipped Learning Approach on Midwifery Students Learning Shoulder Dystocia Management: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06105268
- Acronym / sponsor ID
- 2022/1141
- Conditions
- Shoulder Dystocia - Delivered
- Keywords
- Shoulder Dystocia, flipped learning, midwifery student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 27 Oct 2023 (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.
Flipped learning is an innovative learning method in midwifery education. Studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. For this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education.
Detailed description
Flipped learning is an innovative learning method in midwifery education. Studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. For this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education.
Hypotheses of the research;
First Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' shoulder dystocia knowledge levels.
Second Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' levels of Student Satisfaction and Self-Confidence in Learning.
Third Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' Pagana Clinical Stress levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The sample of the study will consist of two groups: experimental and control. The number of students in each group is the difference between the experimental and control groups in order to determine the effectiveness of shoulder dystocia management given using the flipped learning technique; With 95% confidence (1-α), 95% test power (1-β), d = 1.3000000 effect size and two-sided t test, the number of samples to be taken in each group will be 17 and the study should be conducted with a total of 34 students (16). . Since there is no case of data loss and there is no sample study where the flipped learning technique and shoulder dystocia are used together, a total of 68 students will be studied, 34 students in each group.
| Arm | Type | Receives |
|---|---|---|
| flipped learning group | Experimental | Other: flipped learning training groupIn addition to the traditional theory training to be given within the scope of the study, two hours of video-supported shoulder dystocia training will be given using the university's corporate Microsoft teams program, one day before the simulation application. The videos used in the training consist of previously shot training videos. There is no copyright or legal problem in using the videos. |
| routine training group- control group | No intervention | –The control group will be given shoulder dystocia theory training before the simulation training within the routine course protocol within the scope of the routine risky birth and postpartum period course. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- - Agreeing to participate in the study,
- Being a 4th year student at the Department of Midwifery,
Key exclusion criteria (2 listed)
- - Refusing to participate in the study,
- Being a 1st, 2nd and 3rd year student in the midwifery department
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 |
|---|---|---|
| flipped learning training groupflipped learning training group. Applying a flipped learning model in addition to routine training in a fully equipped simulation | Other | flipped learning group |
Primary outcome
H1
Time frame: 12 months
Using the flipped learning model in midwifery education increases the knowledge level score of midwifery students on shoulder dystocia.
H1
Time frame: 12 months
Using the flipped learning model in midwifery education reduces the PANAGA clinical stress level score of midwifery students.
H1
Time frame: 12 months
Using the flipped learning model in midwifery education increases midwifery students' oStudent Satisfaction and Self-Confidence in Learning Scale scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Results publication: PubMed 37611355Saritas E, Baykara ZG. The effect of flipped learning approach on nursing students' learning of patient safety: A randomized controlled trial. Nurse Educ Pract. 2023 Oct;72:103742. doi: 10.1016/j.nepr.2023.103742. Epub 2023 Aug 10.
- Results publication: PubMed 35183160Golaki SP, Kamali F, Bagherzadeh R, Hajinejad F, Vahedparast H. The effect of Flipped Classroom through Near Peer Education (FC through NPE) on patient safety knowledge retention in nursing and midwifery students: a solomon four-group design. BMC Med Educ. 2022 Feb 19;22(1):112. doi: 10.1186/s12909-022-03144-w.
- Flipped Classroom Learning Experiences of Graduate Nursing Students in Advanced Pathophysiology and Pharmacology in Midwifery CourseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It will be shared when the work is completed.
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. This study is not recruiting at the moment.
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 flipped learning training group in people with Shoulder Dystocia - Delivered, run by Karabuk 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
H1 (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT06105268, 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 28 Jul 2025.