ObstetricNCT05999409
Normal Birth Management and Use of Simulation
A study testing practice on birth simulator in people with Obstetric, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The research; It is planned to evaluate the effectiveness of the use of simulation in the management of normal labor. The research was designed in a quasi-experimental randomized controlled type. The research is carried out in the Department of Midwifery, Faculty of Health Sciences, in the 2022-2023 academic year. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric
- What is being tested?
- practice on birth simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The research includes all third-year students who registered for the first time to the Normal Birth and Postpartum Term course in the midwifery department in the 2022-2023 academic year in the Department of Midwifery at the Faculty of Health Sciences.
Who cannot join
- Having any of the above criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Research and Training Hospital of Tokat Gaziosmanpaşa University
Tokat Province
About this study
Official title: Evaluation of the Effectiveness of Simulation Use in the Management of Normal Labor
The research; It is planned to evaluate the effectiveness of the use of simulation in the management of normal labor.
The research was designed in a quasi-experimental randomized controlled type. The research is carried out in the Department of Midwifery, Faculty of Health Sciences, in the 2022-2023 academic year. The sample of the study consists of all third-year students who enrolled in the Normal Birth and Postpartum Term course in the midwifery department for the first time (102 students who successfully passed the Prenatal I course in the 2021-2022 academic year. These students are in the next 2022-2023 academic year. Registered for the Post Term Course). In the literature; In experimental studies, it has been reported that a sample size of at least 30 people is required in order to perform parametric tests (24). In this study, the number of students in the groups was determined as 32, considering that they may have lost. Students were divided into three groups as experimental (d1= High Reality simulator), (d2= Medium Reality simulator) group and control group (d3= slide and video presentation). The study is carried out with 96 students in total. The students who met the inclusion criteria were given a sequence number and then randomly divided into 3 groups using the https://www.randomizer.org online randomization program.
Data collection tools: In data collection; Introductory Information Form (IIF), Normal Birth Skills Assessment Form (NBSAF), Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) and Evaluation of Simulation-Based Learning Scale (ESSBL) will be used.
Read the detailed description
Introductory Information Form (IIF); It was created by the researchers by scanning the literature (11,25-28). This form includes the socio-demographic characteristics of the students, the presence of a health worker in the family, their normal birth practice status and their simulation training (age, graduated high school, monthly income, presence of a health worker in the family, normal birth practice monitoring and performance, simulation training). receiving status etc.) consists of a total of 10 questions.
Normal Birth Skill Assessment Form (NBSAF) It was created by the researchers by scanning the literature (29-31). In the form, there are 50 items about the steps that the student should do during the normal labor practice. Evaluation of the form is as "he did" and "did not" in relation to the student's implementation of the activities to be observed during the normal labor process steps. In the form, the student was given 2 points for each activity he did, while 0 points were given for the activities he did not do. The lowest score that can be obtained from the form is 0, and the highest score is 100. A high score will indicate high skill, and a low score will indicate low skill.
For the content validity of the NBSAF items, the opinions of 5 experts (2,3,32-34) who have researched on learning techniques related to the management of normal labor were consulted. The Lawshe technique was used to evaluate the content validity of the items in the form. According to the Lawshe technique, the minimum fit criterion was 0.99 for five experts (35). No item with a content validity ratio below 0.99 was detected. In order to test the intelligibility of the items, a pilot study was conducted with 10 students from another class who had no knowledge of the content, and the form was given its final form.
Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) The original scale was developed as 13 items by Jeffries and Rizzolo (2006), and the total number of items decreased to 12 during its adaptation to Turkish. The adaptation of the scale to Turkish was done by Ünver et al. (2017). The scale is a 5-point Likert type and consists of the sub-headings of "Satisfaction with Current Learning" and "Self-Confidence in Learning". The sub-title of satisfaction with current learning consists of 5 items, the sub-title of self-confidence in learning consists of 7 items and there is no negative item. The cronbach alpha value of the scale for "Satisfaction with Current Learning" is .85, while it is .77 for "Self-Confidence in Learning", it is .89 for the total scale. Scale scores; It is obtained by dividing the sum of the sub-dimensions by the number of items. As the total score obtained from the scale increases, student satisfaction and self-confidence in learning also increase.
Evaluation Scale of Simulation-Based Learning (ESSBL) The original scale was developed by Hung et al. (2016), and its Turkish validity and reliability were performed by Uslu and Yavuz van Giersbergen (2020). The Turkish validity and reliability of the scale consists of 5 sub-dimensions and 37 items. Responses are scored on a five-point Likert system, ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score varies between 37-185. All statements in the scale are positive and there is no reverse coded item. Within the scope of the scale, the basic competencies that midwives and nurses should have; care process, patient safety, professional knowledge, communication and reflected behavior concepts are evaluated. An increase in the score obtained from the sub-dimensions in the scale means that the sub-dimension goal has been achieved for the student in the scenario (37).
- Conditions
- Obstetric
- Being tested
- practice on birth simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practice on birth simulatorOther
Also called d2=medium reality birth simulator
making attempts at labor
| Study group | Role | What they receive |
|---|---|---|
| d1 | Experimental | NBSAF's first rating on a full-reality birth simulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made. Receives: Other: practice on birth simulator |
| d2 | Experimental | An initial evaluation of NBSAF was performed on a medium reality labor stimulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made. Receives: Other: practice on birth simulator |
| d3 (control) | No intervention | Without any simulation application, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were performed during the first normal delivery practice of the student in the hospital environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
providing access to the number
enough practice by students
Measured: through study completion, an average of 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Oct 2022
- Primary completion20 Jul 2023
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObstetricStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Responsible party
- Principal investigator, Serap Ozturk Altinayak, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999409
- Sponsor's protocol ID
- 22-KAEK-166
- Status last verified
- Nov 2023
- First submitted
- 2 Aug 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared if requested from researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Simulation Use in the Management of Normal Labor
- ClinicalTrials.gov ID
- NCT05999409
- Acronym / sponsor ID
- 22-KAEK-166
- Conditions
- Obstetric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 21 Aug 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.
The research; It is planned to evaluate the effectiveness of the use of simulation in the management of normal labor.
The research was designed in a quasi-experimental randomized controlled type. The research is carried out in the Department of Midwifery, Faculty of Health Sciences, in the 2022-2023 academic year. The sample of the study consists of all third-year students who enrolled in the Normal Birth and Postpartum Term course in the midwifery department for the first time (102 students who successfully passed the Prenatal I course in the 2021-2022 academic year. These students are in the next 2022-2023 academic year. Registered for the Post Term Course). In the literature; In experimental studies, it has been reported that a sample size of at least 30 people is required in order to perform parametric tests (24). In this study, the number of students in the groups was determined as 32, considering that they may have lost. Students were divided into three groups as experimental (d1= High Reality simulator), (d2= Medium Reality simulator) group and control group (d3= slide and video presentation). The study is carried out with 96 students in total. The students who met the inclusion criteria were given a sequence number and then randomly divided into 3 groups using the https://www.randomizer.org online randomization program.
Data collection tools: In data collection; Introductory Information Form (IIF), Normal Birth Skills Assessment Form (NBSAF), Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) and Evaluation of Simulation-Based Learning Scale (ESSBL) will be used.
Detailed description
Introductory Information Form (IIF); It was created by the researchers by scanning the literature (11,25-28). This form includes the socio-demographic characteristics of the students, the presence of a health worker in the family, their normal birth practice status and their simulation training (age, graduated high school, monthly income, presence of a health worker in the family, normal birth practice monitoring and performance, simulation training). receiving status etc.) consists of a total of 10 questions.
Normal Birth Skill Assessment Form (NBSAF) It was created by the researchers by scanning the literature (29-31). In the form, there are 50 items about the steps that the student should do during the normal labor practice. Evaluation of the form is as "he did" and "did not" in relation to the student's implementation of the activities to be observed during the normal labor process steps. In the form, the student was given 2 points for each activity he did, while 0 points were given for the activities he did not do. The lowest score that can be obtained from the form is 0, and the highest score is 100. A high score will indicate high skill, and a low score will indicate low skill.
For the content validity of the NBSAF items, the opinions of 5 experts (2,3,32-34) who have researched on learning techniques related to the management of normal labor were consulted. The Lawshe technique was used to evaluate the content validity of the items in the form. According to the Lawshe technique, the minimum fit criterion was 0.99 for five experts (35). No item with a content validity ratio below 0.99 was detected. In order to test the intelligibility of the items, a pilot study was conducted with 10 students from another class who had no knowledge of the content, and the form was given its final form.
Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) The original scale was developed as 13 items by Jeffries and Rizzolo (2006), and the total number of items decreased to 12 during its adaptation to Turkish. The adaptation of the scale to Turkish was done by Ünver et al. (2017). The scale is a 5-point Likert type and consists of the sub-headings of "Satisfaction with Current Learning" and "Self-Confidence in Learning". The sub-title of satisfaction with current learning consists of 5 items, the sub-title of self-confidence in learning consists of 7 items and there is no negative item. The cronbach alpha value of the scale for "Satisfaction with Current Learning" is .85, while it is .77 for "Self-Confidence in Learning", it is .89 for the total scale. Scale scores; It is obtained by dividing the sum of the sub-dimensions by the number of items. As the total score obtained from the scale increases, student satisfaction and self-confidence in learning also increase.
Evaluation Scale of Simulation-Based Learning (ESSBL) The original scale was developed by Hung et al. (2016), and its Turkish validity and reliability were performed by Uslu and Yavuz van Giersbergen (2020). The Turkish validity and reliability of the scale consists of 5 sub-dimensions and 37 items. Responses are scored on a five-point Likert system, ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score varies between 37-185. All statements in the scale are positive and there is no reverse coded item. Within the scope of the scale, the basic competencies that midwives and nurses should have; care process, patient safety, professional knowledge, communication and reflected behavior concepts are evaluated. An increase in the score obtained from the sub-dimensions in the scale means that the sub-dimension goal has been achieved for the student in the scenario (37).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| d1 | Experimental | Other: practice on birth simulatorNBSAF's first rating on a full-reality birth simulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made. |
| d2 | Experimental | Other: practice on birth simulatorAn initial evaluation of NBSAF was performed on a medium reality labor stimulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made. |
| d3 (control) | No intervention | –Without any simulation application, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were performed during the first normal delivery practice of the student in the hospital environment. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The research includes all third-year students who registered for the first time to the Normal Birth and Postpartum Term course in the midwifery department in the 2022-2023 academic year in the Department of Midwifery at the Faculty of Health Sciences.
Key exclusion criteria (1 listed)
- Having any of the above criteria
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 |
|---|---|---|
| practice on birth simulatorAlso: d2=medium reality birth simulatormaking attempts at labor | Other | d1, d2 |
Primary outcome
providing access to the number
Time frame: through study completion, an average of 9 month
enough practice by students
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Undecided. Data can be shared if requested from researchers.
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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 practice on birth simulator in people with Obstetric, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 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?
Results are not available in the source record.
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?
providing access to the number (time frame: through study completion, an average of 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.