Childbirth ProblemsNCT06241443
Nursing Students & Positive Birth Perception & Simulation
A study testing hybrid simulation and video-modeling in people with Childbirth Problems, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to investigate the impact of simulation-based training on nursing students' perception of positive birth and natural birthing approaches. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childbirth Problems
- What is being tested?
- hybrid simulation and video-modeling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 20 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The voluntarily agree to participate in the study Not having experience with simulation Being a 4th year nursing undergraduate student not working as a nurse
Who cannot join
- During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Simulation-Based Education on Positive Birth Perception and Natural Birth Approach
The study aimed to investigate the impact of simulation-based training on nursing students' perception of positive birth and natural birthing approaches.
Read the detailed description
This study aimed to determine whether simulation-based training could improve the perception of positive birth and natural birthing approaches among fourth-year nursing students. The study used a randomized controlled quasi-experimental design with pre-test and post-test. The intervention group received hybrid simulation, while the other received video-modeling training. The study used several tools to assess the impact of the training, including the Demographic Information Form, Natural Birth Approach Questionnaire, Student Satisfaction and Confidence in Learning Scale, Satisfaction with Education Methods Questionnaire, and Natural Birth Approach Clinical Skills Guide.
- Conditions
- Childbirth Problems
- Being tested
- hybrid simulation, video-modeling
- Keywords
- childbirth experience, nursing students, simulation-based education, positive birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid simulationOther
During the hybrid simulation, a student and a standardized patient participated. The patient wore a wearable pregnancy model. Before the start of the "Natural Birth Approach Scenario, a pre-briefing session was conducted. The student's performance during the simulation was recorded on video, and each simulation lasted approximately 30 minutes. After the simulation, a debriefing session was held with the student, and feedback was given. Scales were used to evaluate the implementation of the practices.
video-modelingOther
The students in the group had the opportunity to learn through an educational video that followed the "Natural Birth Approach Scenario." Afterward, they put their knowledge into practice and were evaluated using the Birth Approach Clinical Skills Guide. A feedback session followed the practice session. Finally, they were assessed using scales to measure their performance.
| Study group | Role | What they receive |
|---|---|---|
| hybrid simulation | Experimental | These students participated in a natural birth approach scenario with a hybrid simulation (n=28). Receives: Other: hybrid simulation |
| video-modeling group | Active comparator | The students in this group participated in a video modeling education (n=28). Receives: Other: video-modeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural Birth Approach Questionnaire
The researchers developed a measurement tool to assess students' knowledge, opinions, and approaches to natural birth. The tool uses a scoring system where correct statements receive one point and incorrect statements receive zero points. The total score ranges from 0 to 100 points.
Measured: change from before implemention and 4th week of after practice
students' self-confidence and satisfaction
It is a scale published by the National League for Nurses (NLN) to measure students' attitudes and beliefs about simulation.The highest score that can be obtained from the scale is 65 and the lowest score is 13.
Measured: through simulation practices completion, an average of 5 weeks
education methods satisfaction
It evaluates the degree of contentment of the student with the teaching methodology implemented.In evaluating the satisfaction with training methods, students are scored from 20 to 80.
Measured: through simulation practices completion, an average of 5 weeks
Natural Birth Approach Skills
The researchers developed a checklist to assess skills. Each item was evaluated on a 3-point scale indicating inadequacy, partial sufficiency, or sufficiency. The checklist consists of 21 items. The total score ranges from 21 to 63 points.
Measured: through simulation practices completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Sep 2022
- Primary completion20 May 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childbirth ProblemsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, parallel, randomized, controlled quasi-experiment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sümeyye bakır, Ege University
- Investigators
- sümeyye bakır, master, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241443
- Sponsor's protocol ID
- E.1161
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers intend to publish the study as an article
Publications
Dunbar-Reid K, Sinclair PM, Hudson D. Advancing renal education: hybrid simulation, using simulated patients to enhance realism in haemodialysis education. J Ren Care. 2015 Jun;41(2):134-9. doi: 10.1111/jorc.12112. Epub 2015 Jan 29.
PubMed 25631292Bakke E, Oseth EH, Fofanah T, Sesay I, van Duinen A, Bolkan HA, Westendorp J, Lonnee-Hoffmann R. Vacuum births and barriers to its use: An observational study in governmental hospitals in Sierra Leone. BMJ Open. 2022 Nov 22;12(11):e060773. doi: 10.1136/bmjopen-2022-060773.
PubMed 36414288Duff J, Kardong-Edgren S, Chang TP, Elkin RL, Ramachandra G, Stapleton S, Palaganas JC, Kou M, Gross IT. Closing the gap: a call for a common blueprint for remote distance telesimulation. BMJ Simul Technol Enhanc Learn. 2021 Apr 12;7(4):185-187. doi: 10.1136/bmjstel-2021-000875. eCollection 2021.
PubMed 35516822
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Simulation-Based Education on Positive Birth Perception and Natural Birth Approach
- ClinicalTrials.gov ID
- NCT06241443
- Acronym / sponsor ID
- E.1161
- Conditions
- Childbirth Problems
- Keywords
- childbirth experience, nursing students, simulation-based education, positive birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 5 Feb 2024 (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 study aimed to investigate the impact of simulation-based training on nursing students' perception of positive birth and natural birthing approaches.
Detailed description
This study aimed to determine whether simulation-based training could improve the perception of positive birth and natural birthing approaches among fourth-year nursing students. The study used a randomized controlled quasi-experimental design with pre-test and post-test. The intervention group received hybrid simulation, while the other received video-modeling training. The study used several tools to assess the impact of the training, including the Demographic Information Form, Natural Birth Approach Questionnaire, Student Satisfaction and Confidence in Learning Scale, Satisfaction with Education Methods Questionnaire, and Natural Birth Approach Clinical Skills Guide.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, parallel, randomized, controlled quasi-experiment
| Arm | Type | Receives |
|---|---|---|
| hybrid simulation | Experimental | Other: hybrid simulationThese students participated in a natural birth approach scenario with a hybrid simulation (n=28). |
| video-modeling group | Active comparator | Other: video-modelingThe students in this group participated in a video modeling education (n=28). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The voluntarily agree to participate in the study Not having experience with simulation Being a 4th year nursing undergraduate student not working as a nurse
Key exclusion criteria (1 listed)
- During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
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 |
|---|---|---|
| hybrid simulationDuring the hybrid simulation, a student and a standardized patient participated. The patient wore a wearable pregnancy model. Before the start of the "Natural Birth Approach Scenario, a pre-briefing session was conducted. The student's performance during the simulation was recorded on video, and each simulation lasted approximately 30 minutes. After the simulation, a debriefing session was held with the student, and feedback was given. Scales were used to evaluate the implementation of the practices. | Other | hybrid simulation |
| video-modelingThe students in the group had the opportunity to learn through an educational video that followed the "Natural Birth Approach Scenario." Afterward, they put their knowledge into practice and were evaluated using the Birth Approach Clinical Skills Guide. A feedback session followed the practice session. Finally, they were assessed using scales to measure their performance. | Other | video-modeling group |
Primary outcome
Natural Birth Approach Questionnaire
Time frame: change from before implemention and 4th week of after practice
The researchers developed a measurement tool to assess students' knowledge, opinions, and approaches to natural birth. The tool uses a scoring system where correct statements receive one point and incorrect statements receive zero points. The total score ranges from 0 to 100 points.
students' self-confidence and satisfaction
Time frame: through simulation practices completion, an average of 5 weeks
It is a scale published by the National League for Nurses (NLN) to measure students' attitudes and beliefs about simulation.The highest score that can be obtained from the scale is 65 and the lowest score is 13.
education methods satisfaction
Time frame: through simulation practices completion, an average of 5 weeks
It evaluates the degree of contentment of the student with the teaching methodology implemented.In evaluating the satisfaction with training methods, students are scored from 20 to 80.
Natural Birth Approach Skills
Time frame: through simulation practices completion, an average of 5 weeks
The researchers developed a checklist to assess skills. Each item was evaluated on a 3-point scale indicating inadequacy, partial sufficiency, or sufficiency. The checklist consists of 21 items. The total score ranges from 21 to 63 points.
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 5 Feb 2024.
- Background: PubMed 25631292Dunbar-Reid K, Sinclair PM, Hudson D. Advancing renal education: hybrid simulation, using simulated patients to enhance realism in haemodialysis education. J Ren Care. 2015 Jun;41(2):134-9. doi: 10.1111/jorc.12112. Epub 2015 Jan 29.
- Results publication: PubMed 36414288Bakke E, Oseth EH, Fofanah T, Sesay I, van Duinen A, Bolkan HA, Westendorp J, Lonnee-Hoffmann R. Vacuum births and barriers to its use: An observational study in governmental hospitals in Sierra Leone. BMJ Open. 2022 Nov 22;12(11):e060773. doi: 10.1136/bmjopen-2022-060773.
- Results publication: PubMed 35516822Duff J, Kardong-Edgren S, Chang TP, Elkin RL, Ramachandra G, Stapleton S, Palaganas JC, Kou M, Gross IT. Closing the gap: a call for a common blueprint for remote distance telesimulation. BMJ Simul Technol Enhanc Learn. 2021 Apr 12;7(4):185-187. doi: 10.1136/bmjstel-2021-000875. eCollection 2021.
- Individual participant dataSharing planned: Yes. The researchers intend to publish the study as an article
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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 bakır, master principal investigator
Ege 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 hybrid simulation and video-modeling in people with Childbirth Problems, run by Ege 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 5 Feb 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. 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?
Natural Birth Approach Questionnaire (time frame: change from before implemention and 4th week of after practice). The study lists 4 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 NCT06241443, which also lists 3 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 5 Feb 2024.