BehaviorNCT04656574
The Effects of Sımulatıon Used in Vagınal Chıldbırth on Malpractıce Tendency And Perceptıons of Care Behavıors
A study testing Simulation-based training in people with Behavior and Perceptions, run by Aysegul Durmaz at 2 sites in Turkey (Türkiye).
Trial summary
H1a: The simulation-based training used to provide delivery skills have an effect on malpractice trends of midwifery students. H1b: The simulation-based training used to provide delivery skills have an effect on midwifery students' perceptions of care behaviors. 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
- Behavior, Perceptions
- What is being tested?
- Simulation-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 26 Sep 2016to 18 Sep 2017
- 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
- To receive simulation based training
- Older than 18 years,
- To Voluntary to participate,
- To know how to read, write and speak in Turkish,
- To do model work
- Fully completed the data collection forms
- To continue the all course
Who cannot join
- To received theoretical training,
- Younger than 18 years,
- Refuse to participate
- Not knowing how to read, write and speak Turkish,
- Not to do model work
- Not to fill the questionnaire
- Not to continue the course
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kutahya Health Science University
Kütahya, 43000
Kutahya Health Science University
Kütahya
About this study
Official title: The Effects of Mıxed Sımulatıon Traınıng Used in Vagınal Chıldbırth Wıth Epısıotomy on Student Medıcal Malpractıce Tendency And Perceptıons of Care Behavıors
H1a: The simulation-based training used to provide delivery skills have an effect on malpractice trends of midwifery students.
H1b: The simulation-based training used to provide delivery skills have an effect on midwifery students' perceptions of care behaviors.
H0a: The simulation-based training used to provide delivery skills have not an effect on malpractice trends of midwifery students.
H0b: The simulation-based training used to provide delivery skills have not an effect on midwifery students' perceptions of care behaviors.
Read the detailed description
The study was conducted as a single blind, prospective, and simple randomized controlled trial. The study was conducted in the fall semester of 2016 and in the fall semester of 2017 in the midwifery department of a university.
The study universe comprised 79 students who took the course about vaginal delivery (which is included in the midwifery curriculum) provided using simulation-based training and 90 students taking this course for the first time. The study included 120 participants, including 60 randomly selected students who agreed to participate in the study, were enrolled in midwifery, and took the course explaining vaginal delivery for the first time and 60 randomly selected students who received this education using simulation-based training.
The simulation training included the activities that midwives should do during the birth and management of vaginal delivery. Bone pelvis, fetal head, fetus, cervical dilatation-effacement, fetal descensus, maternal-neonatal birthing simulators and chicken breast model for episiotomy were used by the researchers to monitor, manage, and provide care for the progress of labor. The students in the control group received theoretical training about management and care of vaginal delivery. In addition, the researchers demonstrated them how to monitor and manage the delivery process and provide care.
Data collection tools included a personal information form, medical malpractice tendency scale in nursing, and caring assessment questionnaire.
Statistical analyses were made using Statistical Package for Social Sciences (IBM SPSS) Statistics 22 software. The findings were analyzed using descriptive statistics (average, standard deviation, frequency, and percentage). The Kolmogorov-Smirnov test was used to determine normal distribution of the data.
- Conditions
- Behavior, Perceptions
- Being tested
- Simulation-based training
- Keywords
- Episiotomy, Medical Malpractice, Perceptions, Simulation, Vaginal Childbirth
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based trainingBehavioural
The simulation training included the activities that midwives should do during the birth and management of vaginal delivery with episiotomy. The students received theoretical training, and to reinforce it, they were asked to mold a fetal head from a potato, make a cardboard cervix showing dilatation measurements during vaginal delivery, and make a fetal position identification model taking the occiput as a reference point.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group received the course explaining vaginal delivery for the first timethat used simulation-based training. Receives: Behavioral: Simulation-based training |
| Control Group | No intervention | Control group received the course explaining vaginal delivery for the first time |
What is being measured
The primary outcome is the main question the study is designed to answer.
medical malpractice tendency
The medical malpractice tendency scale in nursing includes routine patient care activities of the nurses. It was developed by Özata and Altunkan (14). The Likert-type scale, scored between 1 and 5, includes 49 items and consists of five subscales. The scoring is 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always. The minimum score is 49 and maximum is 245 points. A higher total score indicates that nurses have less medical malpractice tendencies. The scale includes five subscales: drug and transfusion administration, prevention of infections, patient monitıring and material-device safety, prevention of falls, and communication.
Measured: 2 week after the intervention
Perceptions of care behaviors
Caring Assessment Questionnaire/Care-Q scale: The caring assessment questionnaire/Care-Q was developed by Lee, Larson, and Holzemer (18) and adapted to Turkish by Eskimez and Acaroğlu (19). This Likert-type scale, scored between 1 and 7, includes 50 items and consists of six subscales. The scoring is 1=Never, 2=Rarely, 3=Occasionally, 4=Sometimes, 5=Frequently, 6=Usually, 7=Every time. The minimum score is 50 and maximum is 350 points. A higher score indicates a positive increase in the frequency of providing and perceiving care behaviors. The six subscales are attainability, descriptions and facilities, comfort, expectations, reassuring communication, and observation and follow-up.
Measured: 2 week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start26 Sep 2016
- Primary completion7 Jan 2017
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies 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 as a single blind, prospective, and simple randomized controlled trial. A power calculation was performed and with a standard deviation of 0.25 and statistical significance of 0.05, the number of students needed to total participate was determined to be 116, 58 per group. Out of 79 students, 60 were randomly assigned to the experimental group receiving education using simulation-based training and out of 90 students, 60 were randomly assigned to the control group that received the course explaining vaginal delivery for the first time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysegul Durmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysegul Durmaz, Kutahya Health Sciences University
- Investigators
- Aysegul Durmaz, Principal investigator, KSBU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656574
- Sponsor's protocol ID
- Sim. Malp. Percep.
- Status last verified
- Dec 2020
- First submitted
- 28 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Dearnley CA, Meddings FS. Student self-assessment and its impact on learning - a pilot study. Nurse Educ Today. 2007 May;27(4):333-40. doi: 10.1016/j.nedt.2006.05.014. Epub 2006 Jul 25.
PubMed 16870309Valen K, Holm AL, Jensen KT, Grov EK. Nursing students' perception on transferring experiences in palliative care simulation to practice. Nurse Educ Today. 2019 Jun;77:53-58. doi: 10.1016/j.nedt.2019.03.007. Epub 2019 Mar 30.
PubMed 30954856Lendahls 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 28006699Doody O, Condon M. Using a simulated environment to support students learning clinical skills. Nurse Educ Pract. 2013 Nov;13(6):561-6. doi: 10.1016/j.nepr.2013.03.011. Epub 2013 Apr 18.
PubMed 23602694Posmontier B, Montgomery K, Smith Glasgow ME, Montgomery OC, Morse K. Transdisciplinary teamwork simulation in obstetrics-gynecology health care education. J Nurs Educ. 2012 Mar;51(3):176-9. doi: 10.3928/01484834-20120127-02. Epub 2012 Jan 27.
PubMed 22283152Miles DA. Simulation Learning and Transfer in Undergraduate Nursing Education: A Grounded Theory Study. J Nurs Educ. 2018 Jun 1;57(6):347-353. doi: 10.3928/01484834-20180522-05.
PubMed 29863735Cantrell ML, Meyer SL, Mosack V. Effects of Simulation on Nursing Student Stress: An Integrative Review. J Nurs Educ. 2017 Mar 1;56(3):139-144. doi: 10.3928/01484834-20170222-04.
PubMed 28263351Landeen J, Pierazzo J, Akhtar-Danesh N, Baxter P, van Eijk S, Evers C. Exploring Student and Faculty Perceptions of Clinical Simulation: A Q-Sort Study. J Nurs Educ. 2015 Sep;54(9):485-91. doi: 10.3928/01484834-20150814-02.
PubMed 26334334Guler H, Cetin P, Yurtsal ZB, Cesur B, Bekar M, Ucar T, Evcili F, Cetin A. Effect of episiotomy training with beef tongue and sponge simulators on the self-confidence building of midwifery students. Nurse Educ Pract. 2018 May;30:1-6. doi: 10.1016/j.nepr.2018.02.004. Epub 2018 Feb 9.
PubMed 29452943
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mıxed Sımulatıon Traınıng Used in Vagınal Chıldbırth Wıth Epısıotomy on Student Medıcal Malpractıce Tendency And Perceptıons of Care Behavıors
- ClinicalTrials.gov ID
- NCT04656574
- Acronym / sponsor ID
- Sim. Malp. Percep.
- Conditions
- Behavior, Perceptions
- Keywords
- Episiotomy, Medical Malpractice, Perceptions, Simulation, Vaginal Childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aysegul DurmazUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 7 Jan 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 7 Dec 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.
H1a: The simulation-based training used to provide delivery skills have an effect on malpractice trends of midwifery students.
H1b: The simulation-based training used to provide delivery skills have an effect on midwifery students' perceptions of care behaviors.
H0a: The simulation-based training used to provide delivery skills have not an effect on malpractice trends of midwifery students.
H0b: The simulation-based training used to provide delivery skills have not an effect on midwifery students' perceptions of care behaviors.
Detailed description
The study was conducted as a single blind, prospective, and simple randomized controlled trial. The study was conducted in the fall semester of 2016 and in the fall semester of 2017 in the midwifery department of a university.
The study universe comprised 79 students who took the course about vaginal delivery (which is included in the midwifery curriculum) provided using simulation-based training and 90 students taking this course for the first time. The study included 120 participants, including 60 randomly selected students who agreed to participate in the study, were enrolled in midwifery, and took the course explaining vaginal delivery for the first time and 60 randomly selected students who received this education using simulation-based training.
The simulation training included the activities that midwives should do during the birth and management of vaginal delivery. Bone pelvis, fetal head, fetus, cervical dilatation-effacement, fetal descensus, maternal-neonatal birthing simulators and chicken breast model for episiotomy were used by the researchers to monitor, manage, and provide care for the progress of labor. The students in the control group received theoretical training about management and care of vaginal delivery. In addition, the researchers demonstrated them how to monitor and manage the delivery process and provide care.
Data collection tools included a personal information form, medical malpractice tendency scale in nursing, and caring assessment questionnaire.
Statistical analyses were made using Statistical Package for Social Sciences (IBM SPSS) Statistics 22 software. The findings were analyzed using descriptive statistics (average, standard deviation, frequency, and percentage). The Kolmogorov-Smirnov test was used to determine normal distribution of the data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was conducted as a single blind, prospective, and simple randomized controlled trial. A power calculation was performed and with a standard deviation of 0.25 and statistical significance of 0.05, the number of students needed to total participate was determined to be 116, 58 per group. Out of 79 students, 60 were randomly assigned to the experimental group receiving education using simulation-based training and out of 90 students, 60 were randomly assigned to the control group that received the course explaining vaginal delivery for the first time.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Simulation-based trainingExperimental group received the course explaining vaginal delivery for the first timethat used simulation-based training. |
| Control Group | No intervention | –Control group received the course explaining vaginal delivery for the first time |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To receive simulation based training
- Older than 18 years,
- To Voluntary to participate,
- To know how to read, write and speak in Turkish,
- To do model work
Key exclusion criteria (7 listed)
- To received theoretical training,
- Younger than 18 years,
- Refuse to participate
- Not knowing how to read, write and speak Turkish,
- Not to do model work
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 |
|---|---|---|
| Simulation-based trainingThe simulation training included the activities that midwives should do during the birth and management of vaginal delivery with episiotomy. The students received theoretical training, and to reinforce it, they were asked to mold a fetal head from a potato, make a cardboard cervix showing dilatation measurements during vaginal delivery, and make a fetal position identification model taking the occiput as a reference point. | Behavioural | Experimental Group |
Primary outcome
medical malpractice tendency
Time frame: 2 week after the intervention
The medical malpractice tendency scale in nursing includes routine patient care activities of the nurses. It was developed by Özata and Altunkan (14). The Likert-type scale, scored between 1 and 5, includes 49 items and consists of five subscales. The scoring is 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always. The minimum score is 49 and maximum is 245 points. A higher total score indicates that nurses have less medical malpractice tendencies. The scale includes five subscales: drug and transfusion administration, prevention of infections, patient monitıring and material-device safety, prevention of falls, and communication.
Perceptions of care behaviors
Time frame: 2 week after the intervention
Caring Assessment Questionnaire/Care-Q scale: The caring assessment questionnaire/Care-Q was developed by Lee, Larson, and Holzemer (18) and adapted to Turkish by Eskimez and Acaroğlu (19). This Likert-type scale, scored between 1 and 7, includes 50 items and consists of six subscales. The scoring is 1=Never, 2=Rarely, 3=Occasionally, 4=Sometimes, 5=Frequently, 6=Usually, 7=Every time. The minimum score is 50 and maximum is 350 points. A higher score indicates a positive increase in the frequency of providing and perceiving care behaviors. The six subscales are attainability, descriptions and facilities, comfort, expectations, reassuring communication, and observation and follow-up.
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 7 Dec 2020.
- Results publication: PubMed 16870309Dearnley CA, Meddings FS. Student self-assessment and its impact on learning - a pilot study. Nurse Educ Today. 2007 May;27(4):333-40. doi: 10.1016/j.nedt.2006.05.014. Epub 2006 Jul 25.
- Results publication: PubMed 30954856Valen K, Holm AL, Jensen KT, Grov EK. Nursing students' perception on transferring experiences in palliative care simulation to practice. Nurse Educ Today. 2019 Jun;77:53-58. doi: 10.1016/j.nedt.2019.03.007. Epub 2019 Mar 30.
- 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 23602694Doody O, Condon M. Using a simulated environment to support students learning clinical skills. Nurse Educ Pract. 2013 Nov;13(6):561-6. doi: 10.1016/j.nepr.2013.03.011. Epub 2013 Apr 18.
- Results publication: PubMed 22283152Posmontier B, Montgomery K, Smith Glasgow ME, Montgomery OC, Morse K. Transdisciplinary teamwork simulation in obstetrics-gynecology health care education. J Nurs Educ. 2012 Mar;51(3):176-9. doi: 10.3928/01484834-20120127-02. Epub 2012 Jan 27.
- Results publication: PubMed 29863735Miles DA. Simulation Learning and Transfer in Undergraduate Nursing Education: A Grounded Theory Study. J Nurs Educ. 2018 Jun 1;57(6):347-353. doi: 10.3928/01484834-20180522-05.
- Results publication: PubMed 28263351Cantrell ML, Meyer SL, Mosack V. Effects of Simulation on Nursing Student Stress: An Integrative Review. J Nurs Educ. 2017 Mar 1;56(3):139-144. doi: 10.3928/01484834-20170222-04.
- Results publication: PubMed 26334334Landeen J, Pierazzo J, Akhtar-Danesh N, Baxter P, van Eijk S, Evers C. Exploring Student and Faculty Perceptions of Clinical Simulation: A Q-Sort Study. J Nurs Educ. 2015 Sep;54(9):485-91. doi: 10.3928/01484834-20150814-02.
- Results publication: PubMed 29452943Guler H, Cetin P, Yurtsal ZB, Cesur B, Bekar M, Ucar T, Evcili F, Cetin A. Effect of episiotomy training with beef tongue and sponge simulators on the self-confidence building of midwifery students. Nurse Educ Pract. 2018 May;30:1-6. doi: 10.1016/j.nepr.2018.02.004. Epub 2018 Feb 9.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Aysegul Durmaz principal investigator
KSBU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based training in people with Behavior and Perceptions, run by Aysegul Durmaz at 2 sites 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 7 inclusion and 7 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 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
medical malpractice tendency (time frame: 2 week after the intervention). The study lists 2 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 NCT04656574, which also lists 9 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 7 Dec 2020.