Breech PresentationNCT05827627
Simulation Techniques Used in Breech Birth Management Training
A study testing simulation in people with Breech Presentation, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to assess the effect of two different simulation techniques that are used to improve breech birth management skills of midwifery students on the anxiety, self-efficacy, skill and knowledge levels of students. 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
- Breech Presentation
- What is being tested?
- simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2019to 20 Jan 2020
- 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
Who may be able to join
- Students who were enrolled in the senior year
- Students who participated in the High-Risk Birth Management course
- Students who received theoretical information on breech birth management
- 3. Students who agreed to take part in the study
Who cannot join
- Students who failed in the High-Risk Birth Management course
- Students who did not participate in theoretical education of breech birth management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Efficacy of Two Different Simulation Techniques Used in Breech Birth Management Training: A Randomised Controlled Study
This study was conducted to assess the effect of two different simulation techniques that are used to improve breech birth management skills of midwifery students on the anxiety, self-efficacy, skill and knowledge levels of students.
Read the detailed description
Professional midwives are an integral part of delivering quality sexual, reproductive, maternal, and newborn healthcare. Midwives must have the skills and knowledge to assist childbirth and identify problems when labour progresses well. When a midwife examines a woman in labour, she may encounter an unexpected breech presentation. Therefore, it is important for midwives to have the skills and knowledge to deliver breech babies and assist mother and baby. Recently, caesarean section has been preferred in breech presentations. However, if breech presentation is diagnosed after the active phase, there may not be enough time for preparations for caesarean section, or the woman may refuse surgical intervention. In both cases, the midwife who examines the woman should inform the obstetrician immediately and, if possible, seek the assistance of another midwife or physician who is experienced in vaginal breech delivery in the management of childbirth. This may result in foetal injury at the hands of inexperienced providers. Midwives and physicians providing intrapartum care must have good training on breech birth manoeuvres and management of the second phase in order to minimise complications. Furthermore, one of the competencies specified by the International Confederation of Midwives (ICM) in midwifery practices is to 'Undertake appropriate manoeuvres and use maternal position to facilitate vertex, face, or breech birth'. Many midwifery education programmes now use various simulators and simulation training to improve the skills of students in high-risk deliveries.
Simulation-based training is an educational method bridging theory and practice and is one of the preferred skill training methods at educational institutions for healthcare professionals. Reasons for preferring this method can be listed as: limited access of students to a qualified faculty in clinical settings, low frequency of situations and limited exposure to actual patients. There are also ethical reasons for using simulation in the education of students, such as minimising risks for patients and providing students with an opportunity to learn through simulation. Simulation training provided before clinical practice helps students to feel safe and well prepared for the clinical setting. Having repetitive training in a safe and secure environment without fear of comprising patient safety is viewed as important for students.
There has been growing interest in simulation and skill training in midwifery education. Simulation laboratories have been established at many universities and training hospitals. The most commonly used simulation types in midwifery education are scenario-based skill training with standardised patients, scenario-based high-technology simulators, and simulators not involving technological design (e.g., episiotomy simulators, pelvic simulators for childbirth, simulator dolls). In midwifery education, it is aimed to teach students basic and advanced practice skills, such as delivering a certain number of babies, making and repairing episiotomies and assisting breech births. Simulation-based learning develops professional competence in midwifery educators as well as equipping and empowering midwifery students regarding practices. In undergraduate midwifery education, students are provided with obstetric skill training in electronic foetal monitoring (EFM), childbirth management, shoulder dystocia, postpartum haemorrhage, breech birth, umbilical cord prolapse and perineal repair (laceration and episiotomy). It has been determined that simulation-based training affected positively participants' perceived readiness. Training provided with high-fidelity, high-technology simulators has been determined to enhance students' self-efficacy, confidence and satisfaction.
It has been aimed to find answers of "is there any difference in students' levels of anxiety, self-efficacy and knowledge on breech birth management between a pelvic simulator group and a computer-based simulator group before and after the training?" and "is there any difference in improving skills in breech birth management between the two groups?"
- Conditions
- Breech Presentation
- Being tested
- simulation
- Keywords
- breech birth, simulation, midwifery students, training
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulationOther
Midwifery student directing the birth of a fetus with frank breech presentation.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic simulator group (PSG) | Other | The trainer positioned the foetus in the pelvic simulator in frank breech presentation. Descent of the baby in the pelvic simulator was administered by a person independent of the study and the training. Receives: Other: simulation |
| Computer-based simulator group (CBSG) | Experimental | The trainer positioned the foetus in the computer-based full-body childbirth simulator in frank breech presentation. The pregnancy simulator streamed audio to increase reality and the patient monitor displayed vital signs of the pregnant simulator and foetal heart rate. Receives: Other: simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory Score Change
The inventory, developed by Spielberger et al. (1970), is a self-evaluation questionnaire involving short evaluations (Spielberger et al., 1983). Its validity and reliability study in Turkey was conducted by Öner and Lecompte (1983) (Öner \& Le Compte, 1983). The inventory consists of two different questionnaires with 40 items in total. The STAI consists of 20 items that aim to assess how the individual feels at a specific time under specific conditions by considering their present feelings and was used in our study. It is a 4-point Likert scale ranging from 'Not at all' to 'Very much so'. The maximum score that can be obtained from the scale is 80, and the minimum score is 20. Higher scores are correlated with higher levels of anxiety.
Measured: pre-intervention, 1 hour after intervention
Self-Efficacy Scale Score Change
Developed by Sherer et al. (1982), the Self-Efficacy Scale is a 5-point Likert scale and consists of 23 items (Gözüm \& Aksayan, 1999; Sherer et al., 1982). The scale measures generalised, non-specific perception of self-efficacy. The scores to be obtained from the scale range from 23 to 115; higher scores represent a good level of self-efficacy perception.
Measured: pre-intervention, 1 hour after intervention
Breech Birth Management Information Form Score Change
This form was developed based on relevant literature (Marshall \& Raynor, 2014; Posner et al., 2013; Shuttler, 2018; Walker, Reading, et al., 2017). It consisted of 17 statements intended to measure the students' level of knowledge on breech birth management. The statements were prepared to include eight correct and nine incorrect statements which were answered by the participants as 'I agree', 'I disagree' or 'I have no idea'. One point was awarded for correct answers and zero points for incorrect and 'no idea' answers. Higher knowledge scores denote a higher level of knowledge on breech birth management.
Measured: pre-intervention, 1 hour after intervention
Breech Birth Management Skill Assessment Form
The Breech Birth Management Skill Assessment Form was prepared by reviewing the relevant literature (Hardy et al., 2020; Jordan et al., 2016; Shuttler, 2018; Walker, Breslin, et al., 2017). The form consisted of 19 items involving steps of breech birth management, such as hand washing, protecting privacy, making necessary explanations to the pregnant woman, determining the presentation of the foetus, informing the pregnant woman about pushing and cooperating, waiting for the umbilical cord to be delivered, assisting the delivery of the baby's arm and head with suitable manoeuvres, informing the woman about the outcomes, and recording the procedures on an observation sheet.The score to be obtained from the form ranged from 19 to 57.
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start10 Nov 2019
- Primary completion10 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breech PresentationStudies 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
- The study was conducted in two groups: a pelvic simulator group (PSG) and a computer-based simulator group (CBSG).
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Hamlaci Baskaya, Sakarya University
- Investigators
- Yasemin Hamlacı Başkaya, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827627
- Sponsor's protocol ID
- 03052019
- Status last verified
- May 2023
- First submitted
- 31 Mar 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal R, Mytton OT, Derbrew M, Hananel D, Heydenburg M, Issenberg B, MacAulay C, Mancini ME, Morimoto T, Soper N, Ziv A, Reznick R. Training and simulation for patient safety. Qual Saf Health Care. 2010 Aug;19 Suppl 2:i34-43. doi: 10.1136/qshc.2009.038562.
PubMed 20693215Bogossian F, McKenna L, Higgins M, Benefer C, Brady S, Fox-Young S, Cooper S. Simulation based learning in Australian midwifery curricula: results of a national electronic survey. Women Birth. 2012 Jun;25(2):86-97. doi: 10.1016/j.wombi.2011.02.001. Epub 2011 Mar 8.
PubMed 21388902Bogren M, Rosengren J, Erlandsson K, Berg M. Build professional competence and Equip with strategies to empower midwifery students - An interview study evaluating a simulation-based learning course for midwifery educators in Bangladesh. Nurse Educ Pract. 2019 Feb;35:27-31. doi: 10.1016/j.nepr.2019.01.002. Epub 2019 Jan 10.
PubMed 30658269Carbillon L, Benbara A, Tigaizin A, Murtada R, Fermaut M, Belmaghni F, Bricou A, Boujenah J. Revisiting the management of term breech presentation: a proposal for overcoming some of the controversies. BMC Pregnancy Childbirth. 2020 May 3;20(1):263. doi: 10.1186/s12884-020-2831-4.
PubMed 32359354Deering S, Brown J, Hodor J, Satin AJ. Simulation training and resident performance of singleton vaginal breech delivery. Obstet Gynecol. 2006 Jan;107(1):86-9. doi: 10.1097/01.AOG.0000192168.48738.77.
PubMed 16394044Hardy L, Garratt JL, Crossley B, Copson S, Nathan E, Calvert K, Epee-Bekima M. A retrospective cohort study of the impact of In Time obstetric simulation training on management of vaginal breech deliveries. Aust N Z J Obstet Gynaecol. 2020 Oct;60(5):704-708. doi: 10.1111/ajo.13132. Epub 2020 Feb 17.
PubMed 32067227Hunter LA. Vaginal breech birth: can we move beyond the Term Breech Trial? J Midwifery Womens Health. 2014 May-Jun;59(3):320-7. doi: 10.1111/jmwh.12198. Epub 2014 Apr 24.
PubMed 24762034Jordan A, Antomarchi J, Bongain A, Tran A, Delotte J. Development and validation of an objective structured assessment of technical skill tool for the practice of breech presentation delivery. Arch Gynecol Obstet. 2016 Aug;294(2):327-32. doi: 10.1007/s00404-016-4063-4. Epub 2016 Mar 11.
PubMed 26969652Lendahls L, Oscarsson MG. Midwifery students' experiences of simulation- and skills training. Nurse Educ Today. 2017 Mar;50:12-16. doi: 10.1016/j.nedt.2016.12.005. Epub 2016 Dec 16.
PubMed 28006699Maskalova E, Urbanova E, Baskova M, Kvaltinyova E. Experience of lecturers with simulation training in midwifery education in Slovakia. Midwifery. 2018 Apr;59:1-3. doi: 10.1016/j.midw.2018.01.001. Epub 2018 Jan 5.
PubMed 29331775Stone H, Crane J, Johnston K, Craig C. Retention of Vaginal Breech Delivery Skills Taught in Simulation. J Obstet Gynaecol Can. 2018 Feb;40(2):205-210. doi: 10.1016/j.jogc.2017.06.029. Epub 2017 Aug 15.
PubMed 28821414Stoodley C, McKellar L, Steen M, Fleet J. Simulation in midwifery education: A descriptive explorative study exploring students' knowledge, confidence and skills in the care of the preterm neonate. Nurse Educ Pract. 2020 Jan;42:102635. doi: 10.1016/j.nepr.2019.102635. Epub 2019 Oct 10.
PubMed 31864035Tyer-Viola L, Zulu B, Maimbolwa M, Guarino A. Evaluation of the use of simulation with student midwives in Zambia. Int J Nurs Educ Scholarsh. 2012 Aug 9;9:/j/ijnes.2012.9.issue-1/1548-923X.2379/1548-923X.2379.xml. doi: 10.1515/1548-923X.2379.
PubMed 22947661Vermeulen J, Beeckman K, Turcksin R, Van Winkel L, Gucciardo L, Laubach M, Peersman W, Swinnen E. The experiences of last-year student midwives with High-Fidelity Perinatal Simulation training: A qualitative descriptive study. Women Birth. 2017 Jun;30(3):253-261. doi: 10.1016/j.wombi.2017.02.014. Epub 2017 Mar 22.
PubMed 28341585Walker S, Breslin E, Scamell M, Parker P. Effectiveness of vaginal breech birth training strategies: An integrative review of the literature. Birth. 2017 Jun;44(2):101-109. doi: 10.1111/birt.12280. Epub 2017 Feb 17.
PubMed 28211102
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of Two Different Simulation Techniques Used in Breech Birth Management Training: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05827627
- Acronym / sponsor ID
- 03052019
- Conditions
- Breech Presentation
- Keywords
- breech birth, simulation, midwifery students, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 25 Apr 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.
This study was conducted to assess the effect of two different simulation techniques that are used to improve breech birth management skills of midwifery students on the anxiety, self-efficacy, skill and knowledge levels of students.
Detailed description
Professional midwives are an integral part of delivering quality sexual, reproductive, maternal, and newborn healthcare. Midwives must have the skills and knowledge to assist childbirth and identify problems when labour progresses well. When a midwife examines a woman in labour, she may encounter an unexpected breech presentation. Therefore, it is important for midwives to have the skills and knowledge to deliver breech babies and assist mother and baby. Recently, caesarean section has been preferred in breech presentations. However, if breech presentation is diagnosed after the active phase, there may not be enough time for preparations for caesarean section, or the woman may refuse surgical intervention. In both cases, the midwife who examines the woman should inform the obstetrician immediately and, if possible, seek the assistance of another midwife or physician who is experienced in vaginal breech delivery in the management of childbirth. This may result in foetal injury at the hands of inexperienced providers. Midwives and physicians providing intrapartum care must have good training on breech birth manoeuvres and management of the second phase in order to minimise complications. Furthermore, one of the competencies specified by the International Confederation of Midwives (ICM) in midwifery practices is to 'Undertake appropriate manoeuvres and use maternal position to facilitate vertex, face, or breech birth'. Many midwifery education programmes now use various simulators and simulation training to improve the skills of students in high-risk deliveries.
Simulation-based training is an educational method bridging theory and practice and is one of the preferred skill training methods at educational institutions for healthcare professionals. Reasons for preferring this method can be listed as: limited access of students to a qualified faculty in clinical settings, low frequency of situations and limited exposure to actual patients. There are also ethical reasons for using simulation in the education of students, such as minimising risks for patients and providing students with an opportunity to learn through simulation. Simulation training provided before clinical practice helps students to feel safe and well prepared for the clinical setting. Having repetitive training in a safe and secure environment without fear of comprising patient safety is viewed as important for students.
There has been growing interest in simulation and skill training in midwifery education. Simulation laboratories have been established at many universities and training hospitals. The most commonly used simulation types in midwifery education are scenario-based skill training with standardised patients, scenario-based high-technology simulators, and simulators not involving technological design (e.g., episiotomy simulators, pelvic simulators for childbirth, simulator dolls). In midwifery education, it is aimed to teach students basic and advanced practice skills, such as delivering a certain number of babies, making and repairing episiotomies and assisting breech births. Simulation-based learning develops professional competence in midwifery educators as well as equipping and empowering midwifery students regarding practices. In undergraduate midwifery education, students are provided with obstetric skill training in electronic foetal monitoring (EFM), childbirth management, shoulder dystocia, postpartum haemorrhage, breech birth, umbilical cord prolapse and perineal repair (laceration and episiotomy). It has been determined that simulation-based training affected positively participants' perceived readiness. Training provided with high-fidelity, high-technology simulators has been determined to enhance students' self-efficacy, confidence and satisfaction.
It has been aimed to find answers of "is there any difference in students' levels of anxiety, self-efficacy and knowledge on breech birth management between a pelvic simulator group and a computer-based simulator group before and after the training?" and "is there any difference in improving skills in breech birth management between the two groups?"
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted in two groups: a pelvic simulator group (PSG) and a computer-based simulator group (CBSG).
| Arm | Type | Receives |
|---|---|---|
| Pelvic simulator group (PSG) | Other | Other: simulationThe trainer positioned the foetus in the pelvic simulator in frank breech presentation. Descent of the baby in the pelvic simulator was administered by a person independent of the study and the training. |
| Computer-based simulator group (CBSG) | Experimental | Other: simulationThe trainer positioned the foetus in the computer-based full-body childbirth simulator in frank breech presentation. The pregnancy simulator streamed audio to increase reality and the patient monitor displayed vital signs of the pregnant simulator and foetal heart rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Students who were enrolled in the senior year
- Students who participated in the High-Risk Birth Management course
- Students who received theoretical information on breech birth management
- 3. Students who agreed to take part in the study
Key exclusion criteria (2 listed)
- Students who failed in the High-Risk Birth Management course
- Students who did not participate in theoretical education of breech birth management
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 |
|---|---|---|
| simulationMidwifery student directing the birth of a fetus with frank breech presentation. | Other | Computer-based simulator group (CBSG), Pelvic simulator group (PSG) |
Primary outcome
State-Trait Anxiety Inventory Score Change
Time frame: pre-intervention, 1 hour after intervention
The inventory, developed by Spielberger et al. (1970), is a self-evaluation questionnaire involving short evaluations (Spielberger et al., 1983). Its validity and reliability study in Turkey was conducted by Öner and Lecompte (1983) (Öner \& Le Compte, 1983). The inventory consists of two different questionnaires with 40 items in total. The STAI consists of 20 items that aim to assess how the individual feels at a specific time under specific conditions by considering their present feelings and was used in our study. It is a 4-point Likert scale ranging from 'Not at all' to 'Very much so'. The maximum score that can be obtained from the scale is 80, and the minimum score is 20. Higher scores are correlated with higher levels of anxiety.
Self-Efficacy Scale Score Change
Time frame: pre-intervention, 1 hour after intervention
Developed by Sherer et al. (1982), the Self-Efficacy Scale is a 5-point Likert scale and consists of 23 items (Gözüm \& Aksayan, 1999; Sherer et al., 1982). The scale measures generalised, non-specific perception of self-efficacy. The scores to be obtained from the scale range from 23 to 115; higher scores represent a good level of self-efficacy perception.
Breech Birth Management Information Form Score Change
Time frame: pre-intervention, 1 hour after intervention
This form was developed based on relevant literature (Marshall \& Raynor, 2014; Posner et al., 2013; Shuttler, 2018; Walker, Reading, et al., 2017). It consisted of 17 statements intended to measure the students' level of knowledge on breech birth management. The statements were prepared to include eight correct and nine incorrect statements which were answered by the participants as 'I agree', 'I disagree' or 'I have no idea'. One point was awarded for correct answers and zero points for incorrect and 'no idea' answers. Higher knowledge scores denote a higher level of knowledge on breech birth management.
Breech Birth Management Skill Assessment Form
Time frame: 1 hours
The Breech Birth Management Skill Assessment Form was prepared by reviewing the relevant literature (Hardy et al., 2020; Jordan et al., 2016; Shuttler, 2018; Walker, Breslin, et al., 2017). The form consisted of 19 items involving steps of breech birth management, such as hand washing, protecting privacy, making necessary explanations to the pregnant woman, determining the presentation of the foetus, informing the pregnant woman about pushing and cooperating, waiting for the umbilical cord to be delivered, assisting the delivery of the baby's arm and head with suitable manoeuvres, informing the woman about the outcomes, and recording the procedures on an observation sheet.The score to be obtained from the form ranged from 19 to 57.
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 10 May 2023.
- Results publication: PubMed 20693215Aggarwal R, Mytton OT, Derbrew M, Hananel D, Heydenburg M, Issenberg B, MacAulay C, Mancini ME, Morimoto T, Soper N, Ziv A, Reznick R. Training and simulation for patient safety. Qual Saf Health Care. 2010 Aug;19 Suppl 2:i34-43. doi: 10.1136/qshc.2009.038562.
- Results publication: PubMed 21388902Bogossian F, McKenna L, Higgins M, Benefer C, Brady S, Fox-Young S, Cooper S. Simulation based learning in Australian midwifery curricula: results of a national electronic survey. Women Birth. 2012 Jun;25(2):86-97. doi: 10.1016/j.wombi.2011.02.001. Epub 2011 Mar 8.
- Results publication: PubMed 30658269Bogren M, Rosengren J, Erlandsson K, Berg M. Build professional competence and Equip with strategies to empower midwifery students - An interview study evaluating a simulation-based learning course for midwifery educators in Bangladesh. Nurse Educ Pract. 2019 Feb;35:27-31. doi: 10.1016/j.nepr.2019.01.002. Epub 2019 Jan 10.
- Results publication: PubMed 32359354Carbillon L, Benbara A, Tigaizin A, Murtada R, Fermaut M, Belmaghni F, Bricou A, Boujenah J. Revisiting the management of term breech presentation: a proposal for overcoming some of the controversies. BMC Pregnancy Childbirth. 2020 May 3;20(1):263. doi: 10.1186/s12884-020-2831-4.
- Results publication: PubMed 16394044Deering S, Brown J, Hodor J, Satin AJ. Simulation training and resident performance of singleton vaginal breech delivery. Obstet Gynecol. 2006 Jan;107(1):86-9. doi: 10.1097/01.AOG.0000192168.48738.77.
- Results publication: PubMed 32067227Hardy L, Garratt JL, Crossley B, Copson S, Nathan E, Calvert K, Epee-Bekima M. A retrospective cohort study of the impact of In Time obstetric simulation training on management of vaginal breech deliveries. Aust N Z J Obstet Gynaecol. 2020 Oct;60(5):704-708. doi: 10.1111/ajo.13132. Epub 2020 Feb 17.
- Results publication: PubMed 24762034Hunter LA. Vaginal breech birth: can we move beyond the Term Breech Trial? J Midwifery Womens Health. 2014 May-Jun;59(3):320-7. doi: 10.1111/jmwh.12198. Epub 2014 Apr 24.
- Results publication: PubMed 26969652Jordan A, Antomarchi J, Bongain A, Tran A, Delotte J. Development and validation of an objective structured assessment of technical skill tool for the practice of breech presentation delivery. Arch Gynecol Obstet. 2016 Aug;294(2):327-32. doi: 10.1007/s00404-016-4063-4. Epub 2016 Mar 11.
- Results publication: PubMed 28006699Lendahls L, Oscarsson MG. Midwifery students' experiences of simulation- and skills training. Nurse Educ Today. 2017 Mar;50:12-16. doi: 10.1016/j.nedt.2016.12.005. Epub 2016 Dec 16.
- Results publication: PubMed 29331775Maskalova E, Urbanova E, Baskova M, Kvaltinyova E. Experience of lecturers with simulation training in midwifery education in Slovakia. Midwifery. 2018 Apr;59:1-3. doi: 10.1016/j.midw.2018.01.001. Epub 2018 Jan 5.
- Results publication: PubMed 28821414Stone H, Crane J, Johnston K, Craig C. Retention of Vaginal Breech Delivery Skills Taught in Simulation. J Obstet Gynaecol Can. 2018 Feb;40(2):205-210. doi: 10.1016/j.jogc.2017.06.029. Epub 2017 Aug 15.
- Results publication: PubMed 31864035Stoodley C, McKellar L, Steen M, Fleet J. Simulation in midwifery education: A descriptive explorative study exploring students' knowledge, confidence and skills in the care of the preterm neonate. Nurse Educ Pract. 2020 Jan;42:102635. doi: 10.1016/j.nepr.2019.102635. Epub 2019 Oct 10.
- Individual participant dataSharing planned: No
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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.
Yasemin Hamlacı Başkaya study director
Sakarya 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 simulation in people with Breech Presentation, run by Sakarya 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 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 10 May 2023. 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?
State-Trait Anxiety Inventory Score Change (time frame: pre-intervention, 1 hour after intervention). 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 NCT05827627, which also lists 16 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 10 May 2023.