BirthNCT06103643
Simulation Based Emergency Brex Birth Management Training
A study testing Using High Reality Simulator in people with Birth, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of SIMULATION-BASED EMERGENCY BREX BIRTH MANAGEMENT TRAINING IMPACT ON STUDENTS' SELF-CONFIDENCE AND COMPETENCE. 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
- Birth
- What is being tested?
- Using High Reality Simulator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2023to 30 Jan 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agreeing to participate in the research and obtaining written permission,
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation-based Emergency Brex Birth Management Training Impact on Students'Self Confidence and Competence
The aim of this study is to determine the effect of SIMULATION-BASED EMERGENCY BREX BIRTH MANAGEMENT TRAINING IMPACT ON STUDENTS' SELF-CONFIDENCE AND COMPETENCE.
Read the detailed description
Hypotheses H01; There was no difference between the students'self-confidence and competence of the simulation-based emergency brex birth management training group and students'self-confidence and competence score control group.
The study will be carried out in two different groups. The practice will start with meeting the students who apply to the study. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Breech birth management training will be given by the responsible investigator, and then one of the groups separated by randomization will perform emergency breech birth on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.
- Conditions
- Birth
- Being tested
- Using High Reality Simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using High Reality SimulatorOther
Also called model
Using High Reality Simulator will perform emergency breech birth.
| Study group | Role | What they receive |
|---|---|---|
| High Reality Simulator | Experimental | Breech birth management training will be given by the responsible investigator, and then one of the groups will be allocated by randomization. Using High Reality Simulator will perform emergency breech birth. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. Receives: Other: Using High Reality Simulator |
| control group | Sham comparator | Using model will perform emergency breech birth. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. Receives: Other: Using High Reality Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Confidence/Efficacy Scale in Patient Intervention
It was developed by Jekins in America in 1983 for nursing students. The scale is used to describe students' perceptions of clinical decision-making based on their own statements (Jenkins, 2001).It was adapted into Turkish by Durmaz-Edeer and Sarıkaya (2015). The sub-dimensions of the scale, which consists of 40 items and four sub-dimensions; "Exploring options and ideas", "Inquiring into goals and values", "Evaluating consequences", and "Searching for information and impartially adopting new information". Each subscale consists of 10 items. The total score of the scale is between 40 and 200, and each subscale is scored between 10 and 50. There is no cutoff point on the scale. A high score from the scale indicates that the perception of decision-making is high, and a low score indicates that the perception of decision-making is low.The scale is evaluated based on each subscale and scale total score (Jenkins, 2001).
Measured: immediately before simulation and immediately after the training 2 months later
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 start25 Oct 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies 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
- parallel
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
- Investigators
- Sümeyye BAL, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103643
- Sponsor's protocol ID
- 2023-732
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2023
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Emergency Brex Birth Management Training Impact on Students'Self Confidence and Competence
- ClinicalTrials.gov ID
- NCT06103643
- Acronym / sponsor ID
- 2023-732
- Conditions
- Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (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.
The aim of this study is to determine the effect of SIMULATION-BASED EMERGENCY BREX BIRTH MANAGEMENT TRAINING IMPACT ON STUDENTS' SELF-CONFIDENCE AND COMPETENCE.
Detailed description
Hypotheses H01; There was no difference between the students'self-confidence and competence of the simulation-based emergency brex birth management training group and students'self-confidence and competence score control group.
The study will be carried out in two different groups. The practice will start with meeting the students who apply to the study. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Breech birth management training will be given by the responsible investigator, and then one of the groups separated by randomization will perform emergency breech birth on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel
| Arm | Type | Receives |
|---|---|---|
| High Reality Simulator | Experimental | Other: Using High Reality SimulatorBreech birth management training will be given by the responsible investigator, and then one of the groups will be allocated by randomization. Using High Reality Simulator will perform emergency breech birth. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. |
| control group | Sham comparator | Other: Using High Reality SimulatorUsing model will perform emergency breech birth. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Agreeing to participate in the research and obtaining written permission,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Using High Reality SimulatorAlso: modelUsing High Reality Simulator will perform emergency breech birth. | Other | High Reality Simulator, control group |
Primary outcome
Self-Confidence/Efficacy Scale in Patient Intervention
Time frame: immediately before simulation and immediately after the training 2 months later
It was developed by Jekins in America in 1983 for nursing students. The scale is used to describe students' perceptions of clinical decision-making based on their own statements (Jenkins, 2001).It was adapted into Turkish by Durmaz-Edeer and Sarıkaya (2015). The sub-dimensions of the scale, which consists of 40 items and four sub-dimensions; "Exploring options and ideas", "Inquiring into goals and values", "Evaluating consequences", and "Searching for information and impartially adopting new information". Each subscale consists of 10 items. The total score of the scale is between 40 and 200, and each subscale is scored between 10 and 50. There is no cutoff point on the scale. A high score from the scale indicates that the perception of decision-making is high, and a low score indicates that the perception of decision-making is low.The scale is evaluated based on each subscale and scale total score (Jenkins, 2001).
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 20 Mar 2024.
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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. This study is not recruiting at the moment.
Sümeyye BAL study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using High Reality Simulator in people with Birth, run by Ondokuz Mayıs 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 1 inclusion and 1 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 20 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Self-Confidence/Efficacy Scale in Patient Intervention (time frame: immediately before simulation and immediately after the training 2 months later). 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 20 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.