EducationNCT07543133
Simulation-Based Childbirth Training and Midwives' Outcomes
A study testing Simulation-Based Childbirth Management Training in people with Education and Maternal Health, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of simulation-based childbirth management training on safe motherhood practices and intrinsic motivation among midwives. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Education, Maternal Health
- What is being tested?
- Simulation-Based Childbirth Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Jun 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Midwives working in healthcare institutions affiliated with the provincial health directorate
- Having 5 years or less professional experience
- Actively involved in prenatal, intrapartum, or postpartum care
- Voluntary participation with written informed consent
Who cannot join
- Working in administrative positions
- Previously received simulation-based childbirth or advanced obstetric simulation training
- Inability to attend the full training program or complete data collection
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 Simulation-Based Childbirth Management Training on Safe Motherhood Practices and Intrinsic Motivation Among Midwives: A Randomized Controlled Study
This randomized controlled study aims to evaluate the effect of simulation-based childbirth management training on safe motherhood practices and intrinsic motivation among midwives. Participants will be randomly assigned to either an intervention group receiving simulation-based training or a control group receiving no additional training. Outcomes will be assessed using validated scales before and after the intervention.
Read the detailed description
Simulation-based training is an effective educational approach that allows healthcare professionals to develop clinical skills in a safe and controlled environment. This study aims to evaluate the effectiveness of simulation-based childbirth management training on safe motherhood practices and intrinsic motivation among midwives.
The study is designed as a randomized controlled trial with a pre-test and post-test design. A total of 132 midwives will be included and randomly assigned to intervention and control groups. The intervention group will receive a structured simulation-based training program over five days, including obstetric scenarios such as normal delivery, postpartum hemorrhage, shoulder dystocia, and other obstetric emergencies. Each session will include pre-briefing, simulation practice, and debriefing.
The control group will continue routine practices without any additional intervention. Data will be collected using a Personal Information Form, Safe Motherhood Scale (for healthcare professionals), and Intrinsic Motivation Scale. Outcomes will be measured before and after the intervention.
The study aims to contribute to evidence-based midwifery education by evaluating both clinical practice outcomes and motivational factors.
- Conditions
- Education, Maternal Health
- Being tested
- Simulation-Based Childbirth Management Training
- Keywords
- Simulation-based training, Midwives, Safe motherhood, Intrinsic motivation, Randomized controlled trial, Obstetric simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based Childbirth Management TrainingBehavioural
Participants will receive simulation-based childbirth management training for five consecutive days (8 hours per day), including structured obstetric scenarios and debriefing sessions.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-Based Training Group | Experimental | Participants will receive simulation-based childbirth management training for five consecutive days (8 hours per day), including structured obstetric scenarios and debriefing sessions. Receives: Behavioral: Simulation-Based Childbirth Management Training |
| Control | No intervention | Participants will continue their routine clinical practice without receiving any additional training during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Motherhood Practices Level
Measured using the Safe MotherhoodScale for Healthcare Professionals before and after the intervention. Assessed using the Safe Motherhood Scale for Healthcare Professionals, a 22-item Likert-type scale evaluating practices related to maternal and newborn safety. Higher scores indicate better safe motherhood practices.Possible score range: 22-110.
Measured: Before training and immediately after training (Day 5)
Intrinsic Motivation Level
Measured using the Intrinsic Motivation Scale before and after the intervention.Assessed using the Intrinsic Motivation Scale, a 21-item Likert-type scale measuring employees' intrinsic motivation across multiple dimensions. Higher scores indicate higher intrinsic motivation. Possible score range: 22-110.
Measured: Before training and immediately after training (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- No masking is applied in this study. Participants and researchers are aware of group assignments due to the nature of the educational intervention.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ERKAL AKSOY, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543133
- Sponsor's protocol ID
- 328886655
- Other IDs
- 11122554533
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Childbirth Management Training on Safe Motherhood Practices and Intrinsic Motivation Among Midwives: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07543133
- Acronym / sponsor ID
- 328886655
- Conditions
- Education, Maternal Health
- Keywords
- Simulation-based training, Midwives, Safe motherhood, Intrinsic motivation, Randomized controlled trial, Obstetric simulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Apr 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 randomized controlled study aims to evaluate the effect of simulation-based childbirth management training on safe motherhood practices and intrinsic motivation among midwives. Participants will be randomly assigned to either an intervention group receiving simulation-based training or a control group receiving no additional training. Outcomes will be assessed using validated scales before and after the intervention.
Detailed description
Simulation-based training is an effective educational approach that allows healthcare professionals to develop clinical skills in a safe and controlled environment. This study aims to evaluate the effectiveness of simulation-based childbirth management training on safe motherhood practices and intrinsic motivation among midwives.
The study is designed as a randomized controlled trial with a pre-test and post-test design. A total of 132 midwives will be included and randomly assigned to intervention and control groups. The intervention group will receive a structured simulation-based training program over five days, including obstetric scenarios such as normal delivery, postpartum hemorrhage, shoulder dystocia, and other obstetric emergencies. Each session will include pre-briefing, simulation practice, and debriefing.
The control group will continue routine practices without any additional intervention. Data will be collected using a Personal Information Form, Safe Motherhood Scale (for healthcare professionals), and Intrinsic Motivation Scale. Outcomes will be measured before and after the intervention.
The study aims to contribute to evidence-based midwifery education by evaluating both clinical practice outcomes and motivational factors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- No masking is applied in this study. Participants and researchers are aware of group assignments due to the nature of the educational intervention.
| Arm | Type | Receives |
|---|---|---|
| Simulation-Based Training Group | Experimental | Behavioral: Simulation-Based Childbirth Management TrainingParticipants will receive simulation-based childbirth management training for five consecutive days (8 hours per day), including structured obstetric scenarios and debriefing sessions. |
| Control | No intervention | –Participants will continue their routine clinical practice without receiving any additional training during the study period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Midwives working in healthcare institutions affiliated with the provincial health directorate
- Having 5 years or less professional experience
- Actively involved in prenatal, intrapartum, or postpartum care
- Voluntary participation with written informed consent
Key exclusion criteria (3 listed)
- Working in administrative positions
- Previously received simulation-based childbirth or advanced obstetric simulation training
- Inability to attend the full training program or complete data collection
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 |
|---|---|---|
| Simulation-Based Childbirth Management TrainingParticipants will receive simulation-based childbirth management training for five consecutive days (8 hours per day), including structured obstetric scenarios and debriefing sessions. | Behavioural | Simulation-Based Training Group |
Primary outcome
Safe Motherhood Practices Level
Time frame: Before training and immediately after training (Day 5)
Measured using the Safe MotherhoodScale for Healthcare Professionals before and after the intervention. Assessed using the Safe Motherhood Scale for Healthcare Professionals, a 22-item Likert-type scale evaluating practices related to maternal and newborn safety. Higher scores indicate better safe motherhood practices.Possible score range: 22-110.
Intrinsic Motivation Level
Time frame: Before training and immediately after training (Day 5)
Measured using the Intrinsic Motivation Scale before and after the intervention.Assessed using the Intrinsic Motivation Scale, a 21-item Likert-type scale measuring employees' intrinsic motivation across multiple dimensions. Higher scores indicate higher intrinsic motivation. Possible score range: 22-110.
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 28 Apr 2026.
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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.
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 Simulation-Based Childbirth Management Training in people with Education and Maternal Health, run by Selcuk 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 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: enrolling by invitation, as of the sponsor's last update on 28 Apr 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?
Safe Motherhood Practices Level (time frame: Before training and immediately after training (Day 5)). 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 28 Apr 2026.