NCT05827627

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

March 31, 2023

Last Update Submit

May 8, 2023

Conditions

Keywords

breech birthsimulationmidwifery studentstraining

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    1 hours

Study Arms (2)

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.

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.

Other: simulation

Interventions

Midwifery student directing the birth of a fetus with frank breech presentation.

Computer-based simulator group (CBSG)Pelvic simulator group (PSG)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \. Students who agreed to take part in the study

You may not qualify if:

  • Students who failed in the High-Risk Birth Management course
  • Students who did not participate in theoretical education of breech birth management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, 54200, Turkey (Türkiye)

Location

Related Publications (16)

  • 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.

  • Bogossian 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.

  • Bogren 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.

  • Carbillon 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.

  • Deering 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.

  • Hardy 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.

  • Hunter 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.

  • Jordan 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.

  • Lendahls 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.

  • Maskalova 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.

  • Stone 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.

  • Stoodley 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.

  • Tyer-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.

  • Vermeulen 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.

  • Walker 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.

  • Walker S, Reading C, Silverwood-Cope O, Cochrane V. Physiological breech birth. Evaluation of a training programme for birth professionals. Pract Midwife. 2017 Feb;20(2):25-8.

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Yasemin Hamlacı Başkaya

    Sakarya University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study was conducted in two groups: a pelvic simulator group (PSG) and a computer-based simulator group (CBSG).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Midwifery Depatment

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 25, 2023

Study Start

November 10, 2019

Primary Completion

January 10, 2020

Study Completion

January 20, 2020

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations