Educational ProblemsNCT04487353
Teaching the Mechanism of Birth by Virtual Reality
A study testing Labor mechanism application developed with virtual reality technology (VRT-LMA) in people with Educational Problems, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
With the virtual birth application, Learning the physiology and mechanism of birth, To monitor the progress of birth and to understand deviations from normal, Learning normal birth, It will provide the opportunity to see all the emergencies that may be encountered at birth and besides these, the information will be… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Labor mechanism application developed with virtual reality technology (VRT-LMA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 12 Feb 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria for the study; Being a 4th year student of Health Sciences University, Gulhane Health Sciences Faculty, Midwifery Department, Volunteering to participate in research Exclusion criteria from the study; Being a first year student. being a second year student being a third year student
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gülhane Faculty of Health Sciences
Ankara, 06018
About this study
Official title: Development And Use Of Virtual Reality Application In Teaching Birth Mechanism
With the virtual birth application,
- Learning the physiology and mechanism of birth,
- To monitor the progress of birth and to understand deviations from normal,
- Learning normal birth,
- It will provide the opportunity to see all the emergencies that may be encountered at birth and besides these, the information will be remembered for a long time.
Read more
In this way, the effectiveness of virtual birth in midwifery education will be evaluated.
Teaching the birth, which is one of the cornerstones of midwifery education and where the students find the opportunity to practice clinically, with virtual reality application, will minimize clinical application errors and will provide early diagnosis of adverse conditions such as fetal presentation and placental anomalies that may occur at birth. It is an up-to-date and important subject that will enable them to see the stages of birth in three dimensions with the virtual delivery application without any obstacle in midwifery education, the birth process, the birth mechanisms of the baby from the birth canal.
Read the detailed description
In recent years, many studies have shown that technology assisted learning is a new learning approach (1); In particular, learning environments involving virtual reality (VR) techniques have become a powerful tool for educators and students (3, 4). Significant progress has been made in various fields, enabling students to interact with the virtual world. These technologies support many educational activities originally offered in web-based learning environments. In midwifery education, the use of simulation has become an important training method in the last decade (2). Simulation is a method that reflects a clinical situation as close to reality as possible, making it easier to understand and manage when this situation is actually encountered in clinical practice. Ensuring patient safety, efforts to increase students' competence have enabled the use of simulation to become more widespread in the training of health professionals (5). Using virtual reality in midwifery education will enable students to use midwifery practices effectively before going to clinical practice. Teaching the birth, which is one of the cornerstones of midwifery education and where the students find the opportunity to practice clinically, with virtual reality application, will minimize clinical application errors and will provide early diagnosis of adverse conditions such as fetal presentation and placental anomalies that may occur at birth.
Type of the Study: The study is an experimental study planned as an experimental and control group.
The research consists of 2 parts. In Part I, Virtual Reality Application will be Developed. Virtual birth software will be prepared through service procurement. For this, algorithms will be created by the researchers by writing in detail the physiology, stages, mechanism and anatomy of the woman in detail.
II. The application of the research will be done in the department.
SECTION I: Development of Virtual Reality Application
In the 1st part of the research, virtual birth software will be prepared through service procurement. For this, algorithms will be created by the researchers by writing in detail the physiology, stages, mechanism and anatomy of the woman in detail. This algorithm will be transferred to the glasses based on the images and drawings of the anatomy of the woman from the birth atlases and the real images shared on the internet at the moment of birth. As stated in the budget form, services will be procured for the development of the virtual birth software.
With the virtual birth application,
- To learn the physiology and mechanism of birth,
- To monitor the progress of the birth and to understand deviations from the normal,
- Learning normal birth,
- It will provide the opportunity to see all the emergencies that may be encountered at birth and besides these, the information will be remembered for a long time. In this way, the effectiveness of virtual birth in midwifery education will be evaluated.
II. Department: Application of the Research
In this last part of the research, the application part of the research has been started. The research will consist of 3 groups, 2 experimental groups and a control group. 35 students will be admitted to each group as a result of G-power analysis calculated with 0.95 power.
The Universe of the research will consist of 464 Midwifery students studying at Karabük University.
The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated by 0.95 power, among midwifery students who took the birth mechanism 4 hours theoretically in their curriculum within the scope of normal birth lesson.
At the first stage: after 4 hours of theory training for all three groups, the information form (DEDBF) to be prepared by the researchers to be used in this research will be applied as the first test.
In the second stage: No application will be made to the control group, computer-aided and guided virtual reality application will be applied to the experimental group, and computer-free and non-guided virtual application will be monitored to the experimental group II.
In the third stage: DEDBF questions will be replaced and posttests will be applied. After the 4-hour theory training for the control group, the post-test will be done after the virtual birth application is watched on the experiment groups. Also, at this stage, "Cognitive Load Scale" and "Feel of Inventory" will be applied to the experimental groups after the application.
In the fourth stage: After three weeks, the DEDBF will be applied again to the three groups, and the effectiveness of the application of virtual birth will be examined in recalling and recalling the information.
During applications, experiment and control group videos and images will be taken and published visually in the thesis.
Students who could not participate in the study and were selected as a control group in randomization will also be provided with virtual reality glasses after the study, so that all students will see the virtual birth application and equality will be achieved.
Data Collection Tools:
Data collection form: It is planned to apply a form consisting of 15 questions, which includes the characteristics of the participants such as age, marital status, educational status and family type.
Birth Action Assessment Information Scale (DEDBF): The scale will be prepared by the researchers themselves for use in this thesis. For the preparation of the form, the latest literature information was reviewed by the researchers, the midwifery core curriculum (EUÇEP) created by YÖK, and a 42-question information form containing items on the physiology, stages and mechanism of delivery was prepared. The items in the information form will be presented to the students in the form of a full sentence that can be true or false, and students will be asked to answer these statements as "True" or "False". Total response time is 30 minutes. Correct answers will be evaluated as 1 point, Wrong answers will be evaluated as 0 points. Wrong expressions were also used in the information form, and these items were coded in reverse compared to others. The lowest score to be taken from the information form is 0 and the highest total score is 42.
Cognitive Load Scale: Kılıç et al. (2004) "Cognitive Load Scale" (BYÖ) adapted to Turkish will be used. It has single factor and nine points (very little, very little, little, partly little, neither more nor less, more, more, more, more, more, more or more). The Cronbach Alpha internal consistency coefficient of the original version was found to be .90 (7). Kılıç et al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient was found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle point is 5.00 and the highest point is 9.00. Participants scoring less than five points were evaluated as "cognitively overloaded", and participants scoring higher than five points were evaluated as "cognitively overloaded".
Availability Sensitivity Scale: It is the scale whose original validity in Turkish was valid in 2018 by Gökoğlu et al. The scale is measured in virtual reality based learning environments. The scale has 5 factors (subscale), namely Participation (Factor 1), Cohesion / Surrounding (Factor 2), Sensory Commitment (Factor 3), Interaction (Factor 4) and Interface Quality (Factor 5) and consists of 29 questions (8 ). According to the exploratory factor analysis (AFA) and confirmatory factor analysis (CFA), the total variance explained by the 5-factor structure was 41.197% and the reliability coefficient of the scale was .844.
Data Analysis of the Research: Analysis of the data of the study will be done using IBM SPSS for Mac book 24 version.
- Conditions
- Educational Problems
- Being tested
- Labor mechanism application developed with virtual reality technology (VRT-LMA)
- Keywords
- virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor mechanism application developed with virtual reality technology (VRT-LMA)Other
In phase I: VRT-LMA application was developed. (Female in lithotomy position, bony pelvis, flexion of the coccyx back about 2 cm and the Hodge plane were modeled as lines. The theory training to be given to the control group was prepared in accordance with the curriculum.
II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered.
II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered.
III. In the second stage: the post-test and analyzes were performed after 5 weeks in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Experiment Group | Experimental | The Labor Evaluation Information Scale (LEIS) was administered as a pre-test before applying to 30 students who had taken a course on childbirth. After the pre-test, the application was carried out with the "Labor mechanism application developed with virtual reality technology (VRT-LMA)". Immediately after the application, data were collected with the "LEIS", "sense of presence scale" and "cognitive load scale". Post-test was performed again with the Labor Evaluation Information Scale (LEIS) 5 weeks after the application. Receives: Other: Labor mechanism application developed with virtual reality technology (VRT-LMA) |
| Control Group | No intervention | Before the theory training, the Assessment Knowledge Scale (LEIS) was administered as a pre-test to 31 students in the control group who had taken a course on obstetrics. After the pre-test, theory training including birth knowledge was given. "Labor mechanism application developed with virtual reality technology (VRT-LMA)" was not applied to the control group. After 4 hours of theoretical training, the final test was performed using LEIS. After 5 weeks, the last test was repeated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Evaluation Information Scale (LEIS)
To measure the knowledge level of both groups about the mechanism of labor. To compare the changes in the knowledge level of students who have experienced VRT-LMA and students who have only theory education.
Measured: within 6 weeks
Secondary outcomes (2)
Cognitive Load Scale
At this stage, "Cognitive Load Scale" will be applied to the experimental groups after the application.
It has single factor and nine points (very little, very little, little, partially little, neither more nor less, more, more, more, more, more, more). The Cronbach Alpha internal consistency coefficient of the original version was found to be .90 (7). Kılıç et al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient was found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle point is 5.00 and the highest point is 9.00. Participants who scored below five points were evaluated as "cognitively overloaded", and participants who scored above five points were evaluated as "cognitively overloaded".
Measured: within 6 weeks
Availability Sensitivity Scale
At this stage, "Availability Sensitivity Scale" will be applied to the experimental groups after the application. Availability Sensitivity Scale: It is the scale whose original validity in Turkish was valid in 2018 by Gökoğlu et al. The scale is measured in virtual reality based learning environments. The scale has 5 factors (subscale), namely Participation (Factor 1), Cohesion / Surrounding (Factor 2), Sensory Commitment (Factor 3), Interaction (Factor 4) and Interface Quality (Factor 5) and consists of 29 questions (8 ). According to the exploratory factor analysis (AFA) and confirmatory factor analysis (CFA), the total variance explained by the 5-factor structure was 41.197% and the reliability coefficient of the scale was .844. It is scored from 1 to 5. 1 ever, 5 are listed as completely.
Measured: within 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start15 Jun 2021
- Primary completion25 Jan 2022
- Study completion12 Feb 2022
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 Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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 will consist of 105 midwifery students, 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated from 0.95 power, among the midwifery students who took the birth mechanism 4 hours theoretically in their curriculum within the scope of normal birth lesson.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Karabuk University
- Responsible party
- Principal investigator, Sebahat Hüseyinoğlu, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487353
- Sponsor's protocol ID
- 2020/256
- Status last verified
- Feb 2022
- First submitted
- 11 Jul 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I'm undecided now. I want to decide in the future
Publications
Cooper S, Cant R, Porter J, Bogossian F, McKenna L, Brady S, Fox-Young S. Simulation based learning in midwifery education: a systematic review. Women Birth. 2012 Jun;25(2):64-78. doi: 10.1016/j.wombi.2011.03.004. Epub 2011 Apr 13.
PubMed 21489894Bjerrum AS, Hilberg O, van Gog T, Charles P, Eika B. Effects of modelling examples in complex procedural skills training: a randomised study. Med Educ. 2013 Sep;47(9):888-98. doi: 10.1111/medu.12199.
PubMed 23931538
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development And Use Of Virtual Reality Application In Teaching Birth Mechanism
- ClinicalTrials.gov ID
- NCT04487353
- Acronym / sponsor ID
- 2020/256
- Conditions
- Educational Problems
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Karabuk University
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 27 Jul 2020 (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.
With the virtual birth application,
- Learning the physiology and mechanism of birth,
- To monitor the progress of birth and to understand deviations from normal,
- Learning normal birth,
- It will provide the opportunity to see all the emergencies that may be encountered at birth and besides these, the information will be remembered for a long time.
In this way, the effectiveness of virtual birth in midwifery education will be evaluated.
Teaching the birth, which is one of the cornerstones of midwifery education and where the students find the opportunity to practice clinically, with virtual reality application, will minimize clinical application errors and will provide early diagnosis of adverse conditions such as fetal presentation and placental anomalies that may occur at birth. It is an up-to-date and important subject that will enable them to see the stages of birth in three dimensions with the virtual delivery application without any obstacle in midwifery education, the birth process, the birth mechanisms of the baby from the birth canal.
Detailed description
In recent years, many studies have shown that technology assisted learning is a new learning approach (1); In particular, learning environments involving virtual reality (VR) techniques have become a powerful tool for educators and students (3, 4). Significant progress has been made in various fields, enabling students to interact with the virtual world. These technologies support many educational activities originally offered in web-based learning environments. In midwifery education, the use of simulation has become an important training method in the last decade (2). Simulation is a method that reflects a clinical situation as close to reality as possible, making it easier to understand and manage when this situation is actually encountered in clinical practice. Ensuring patient safety, efforts to increase students' competence have enabled the use of simulation to become more widespread in the training of health professionals (5). Using virtual reality in midwifery education will enable students to use midwifery practices effectively before going to clinical practice. Teaching the birth, which is one of the cornerstones of midwifery education and where the students find the opportunity to practice clinically, with virtual reality application, will minimize clinical application errors and will provide early diagnosis of adverse conditions such as fetal presentation and placental anomalies that may occur at birth.
Type of the Study: The study is an experimental study planned as an experimental and control group.
The research consists of 2 parts. In Part I, Virtual Reality Application will be Developed. Virtual birth software will be prepared through service procurement. For this, algorithms will be created by the researchers by writing in detail the physiology, stages, mechanism and anatomy of the woman in detail.
II. The application of the research will be done in the department.
SECTION I: Development of Virtual Reality Application
In the 1st part of the research, virtual birth software will be prepared through service procurement. For this, algorithms will be created by the researchers by writing in detail the physiology, stages, mechanism and anatomy of the woman in detail. This algorithm will be transferred to the glasses based on the images and drawings of the anatomy of the woman from the birth atlases and the real images shared on the internet at the moment of birth. As stated in the budget form, services will be procured for the development of the virtual birth software.
With the virtual birth application,
- To learn the physiology and mechanism of birth,
- To monitor the progress of the birth and to understand deviations from the normal,
- Learning normal birth,
- It will provide the opportunity to see all the emergencies that may be encountered at birth and besides these, the information will be remembered for a long time. In this way, the effectiveness of virtual birth in midwifery education will be evaluated.
II. Department: Application of the Research
In this last part of the research, the application part of the research has been started. The research will consist of 3 groups, 2 experimental groups and a control group. 35 students will be admitted to each group as a result of G-power analysis calculated with 0.95 power.
The Universe of the research will consist of 464 Midwifery students studying at Karabük University.
The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated by 0.95 power, among midwifery students who took the birth mechanism 4 hours theoretically in their curriculum within the scope of normal birth lesson.
At the first stage: after 4 hours of theory training for all three groups, the information form (DEDBF) to be prepared by the researchers to be used in this research will be applied as the first test.
In the second stage: No application will be made to the control group, computer-aided and guided virtual reality application will be applied to the experimental group, and computer-free and non-guided virtual application will be monitored to the experimental group II.
In the third stage: DEDBF questions will be replaced and posttests will be applied. After the 4-hour theory training for the control group, the post-test will be done after the virtual birth application is watched on the experiment groups. Also, at this stage, "Cognitive Load Scale" and "Feel of Inventory" will be applied to the experimental groups after the application.
In the fourth stage: After three weeks, the DEDBF will be applied again to the three groups, and the effectiveness of the application of virtual birth will be examined in recalling and recalling the information.
During applications, experiment and control group videos and images will be taken and published visually in the thesis.
Students who could not participate in the study and were selected as a control group in randomization will also be provided with virtual reality glasses after the study, so that all students will see the virtual birth application and equality will be achieved.
Data Collection Tools:
Data collection form: It is planned to apply a form consisting of 15 questions, which includes the characteristics of the participants such as age, marital status, educational status and family type.
Birth Action Assessment Information Scale (DEDBF): The scale will be prepared by the researchers themselves for use in this thesis. For the preparation of the form, the latest literature information was reviewed by the researchers, the midwifery core curriculum (EUÇEP) created by YÖK, and a 42-question information form containing items on the physiology, stages and mechanism of delivery was prepared. The items in the information form will be presented to the students in the form of a full sentence that can be true or false, and students will be asked to answer these statements as "True" or "False". Total response time is 30 minutes. Correct answers will be evaluated as 1 point, Wrong answers will be evaluated as 0 points. Wrong expressions were also used in the information form, and these items were coded in reverse compared to others. The lowest score to be taken from the information form is 0 and the highest total score is 42.
Cognitive Load Scale: Kılıç et al. (2004) "Cognitive Load Scale" (BYÖ) adapted to Turkish will be used. It has single factor and nine points (very little, very little, little, partly little, neither more nor less, more, more, more, more, more, more or more). The Cronbach Alpha internal consistency coefficient of the original version was found to be .90 (7). Kılıç et al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient was found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle point is 5.00 and the highest point is 9.00. Participants scoring less than five points were evaluated as "cognitively overloaded", and participants scoring higher than five points were evaluated as "cognitively overloaded".
Availability Sensitivity Scale: It is the scale whose original validity in Turkish was valid in 2018 by Gökoğlu et al. The scale is measured in virtual reality based learning environments. The scale has 5 factors (subscale), namely Participation (Factor 1), Cohesion / Surrounding (Factor 2), Sensory Commitment (Factor 3), Interaction (Factor 4) and Interface Quality (Factor 5) and consists of 29 questions (8 ). According to the exploratory factor analysis (AFA) and confirmatory factor analysis (CFA), the total variance explained by the 5-factor structure was 41.197% and the reliability coefficient of the scale was .844.
Data Analysis of the Research: Analysis of the data of the study will be done using IBM SPSS for Mac book 24 version.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated from 0.95 power, among the midwifery students who took the birth mechanism 4 hours theoretically in their curriculum within the scope of normal birth lesson.
| Arm | Type | Receives |
|---|---|---|
| Experiment Group | Experimental | Other: Labor mechanism application developed with virtual reality technology (VRT-LMA)The Labor Evaluation Information Scale (LEIS) was administered as a pre-test before applying to 30 students who had taken a course on childbirth. After the pre-test, the application was carried out with the "Labor mechanism application developed with virtual reality technology (VRT-LMA)". Immediately after the application, data were collected with the "LEIS", "sense of presence scale" and "cognitive load scale". Post-test was performed again with the Labor Evaluation Information Scale (LEIS) 5 weeks after the application. |
| Control Group | No intervention | –Before the theory training, the Assessment Knowledge Scale (LEIS) was administered as a pre-test to 31 students in the control group who had taken a course on obstetrics. After the pre-test, theory training including birth knowledge was given. "Labor mechanism application developed with virtual reality technology (VRT-LMA)" was not applied to the control group. After 4 hours of theoretical training, the final test was performed using LEIS. After 5 weeks, the last test was repeated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Labor mechanism application developed with virtual reality technology (VRT-LMA)In phase I: VRT-LMA application was developed. (Female in lithotomy position, bony pelvis, flexion of the coccyx back about 2 cm and the Hodge plane were modeled as lines. The theory training to be given to the control group was prepared in accordance with the curriculum. II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered. II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered. III. In the second stage: the post-test and analyzes were performed after 5 weeks in both groups. | Other | Experiment Group |
Primary outcome
Labor Evaluation Information Scale (LEIS)
Time frame: within 6 weeks
To measure the knowledge level of both groups about the mechanism of labor. To compare the changes in the knowledge level of students who have experienced VRT-LMA and students who have only theory education.
2 secondary outcomes
Cognitive Load Scale
Time frame: within 6 weeks
Availability Sensitivity Scale
Time frame: within 6 weeks
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 4 Mar 2022.
- Background: PubMed 21489894Cooper S, Cant R, Porter J, Bogossian F, McKenna L, Brady S, Fox-Young S. Simulation based learning in midwifery education: a systematic review. Women Birth. 2012 Jun;25(2):64-78. doi: 10.1016/j.wombi.2011.03.004. Epub 2011 Apr 13.
- Background: PubMed 23931538Bjerrum AS, Hilberg O, van Gog T, Charles P, Eika B. Effects of modelling examples in complex procedural skills training: a randomised study. Med Educ. 2013 Sep;47(9):888-98. doi: 10.1111/medu.12199.
- Kılıç, A. G. E., \& Karadeniz, Ö. G. Ş. (2004). Hiper ortamlarda öğrencilerin bilişsel yüklenme ve kaybolma düzeylerinin belirlenmesi. Kuram ve Uygulamada Eğitim Yönetimi, 40(40), 562-579.Link provided by the sponsor.
- Individual participant dataSharing planned: No. I'm undecided now. I want to decide in the future
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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.
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 Labor mechanism application developed with virtual reality technology (VRT-LMA) in people with Educational Problems, run by Saglik Bilimleri Universitesi 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?
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 4 Mar 2022. 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?
Labor Evaluation Information Scale (LEIS) (time frame: within 6 weeks). 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 NCT04487353, 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 4 Mar 2022.