SimulationSCIENCENCT05864859
Empathic Tendency and Privacy Protection Level
A study testing Simulation in people with Simulation and Empathy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Proving the empathy level and privacy protection effectiveness of the low-cost, high-reality and interactive education model constitutes the original value of the project and our main motivation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simulation, Empathy
- What is being tested?
- Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jul 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a final year midwifery student,
- Not being married
- To be nulliparous
- Volunteering to participate in research
Who cannot join
- Having the ability to read, listen, write, speak and understand Turkish,
- Repeating the course,
- Unwilling to withdraw from research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Birth Experience With a Wearable Simulated Motherhood Model on Empathic Tendency and Privacy Protection Level: A Randomized Controlled Study
Proving the empathy level and privacy protection effectiveness of the low-cost, high-reality and interactive education model constitutes the original value of the project and our main motivation. The project has a unique value for a sustainable future in terms of its impact at the social level in terms of midwifery students in particular and positive birth experience and qualified midwifery care in general. It will also provide data for the comparison of innovative education methods with traditional education methods. Thus, it will help to improve, regulate or build capacity of future initiatives.
Read the detailed description
Humanistic care is also conceptualized as the ability to communicate with patients, feel their emotions, meet their needs, and develop harmonious therapeutic relationships. Humanistic care is the essence and connotation of the care process. But developing a sense of humanistic care is quite difficult. Despite emphasizing humanistic care in midwifery education and making great efforts, its integration into professional practice is still not at the desired level .
Empathy refers to the tendency to recognize, help, and respond to other people's experiences and emotions. Empathy allows midwives to measure various situations, understand mothers' situation, perspective, feelings, and apply appropriate woman-centered care. It is stated that empathy can contribute to students' humanistic care skills both directly and indirectly through emotional intelligence.
Birth is one of the most private areas where privacy should be protected, and practices done during childbirth cause embarrassment in women, decrease the level of satisfaction and lead to a negative perception of childbirth. Healthcare professionals have both ethical and legal responsibilities regarding privacy. In order to fulfill their duties towards the individuals they care for, they need to protect the privacy of the individual. In a meta-analysis study examining the ethical decision-making process in care and practices, it was found that it is a difficult process to implement the ethical decision-making process and it is affected by many personal and situational factors.
The use of standardized patient or human actors in simulation practice was initiated in 1963 by a neurologist from the University of Southern California. It is stated that the use of standardized patient or human actors adds more realism to the simulation by allowing training in both procedural and communication skills. With the hybrid simulation, which allows the birth process to be animated as in real life, the human element in birth is preserved and the reality shock they will experience in real life is prevented. It is stated that it adds more realism and interaction thanks to psychological reactions, especially during a clinical event.
It is stated that the use of simulation reflection, role playing, pedagogical theater and real-life case studies should be included in the curriculum in midwifery programs. However, it is stated that there are limited studies with midwifery students. It is stated that the use of standardized patients is beneficial not only for learners, but also for standardized patients themselves. Therefore, it is suggested that more research is needed to examine the mutual benefits of using standardized patients in simulation practice. In this context, proving the empathy level and privacy protection effectiveness of the low-cost, high-reality and interactive education model in line with the literature proposal constitutes the original value of the project and our main motivation. The project has a unique value for a sustainable future in terms of its impact at the social level in terms of midwifery students in particular and positive birth experience and qualified midwifery care in general. It will also provide data for the comparison of innovative education methods with traditional education methods. Thus, it will help to improve, regulate or build capacity of future initiatives.
- Conditions
- Simulation, Empathy
- Being tested
- Simulation
- Keywords
- Simulation, Empathy, Privacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
In the simulation session, while 2 participants (1 midwife, 1 pregnant) performed the roles in accordance with the clinical scenario, the performance was recorded in the control room. A Wearable Pregnancy Simulator was worn by the student performing the pregnant role. During the simulation, the participants were able to interact with the facilitators when they had questions. The application time did not exceed 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Normal birth group | Experimental | It consisted of preliminary information (10 minutes), practice (10 minutes) and analysis (20 minutes) sessions with groups of 2 people (1 midwife, 1 pregnant) accompanied by a scenario where there was no complication during labor. Receives: Other: Simulation |
| Breech birth group | Experimental | It consisted of preliminary information (10 minutes), practice (10 minutes) and analysis (20 minutes) sessions with groups of 2 people (1 midwife, 1 pregnant) accompanied by a scenario that experienced complications during labor. Receives: Other: Simulation |
| Control group | No intervention | She continued her education in accordance with the (1+32) hour curriculum within the scope of the midwifery undergraduate program Integrated Practice I and EBE402 Integrated Practice II courses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Privacy
Privacy Protection Scale in Obstetrics and Gynecology: The scale has 2 sections: awareness level and application frequency, 2 sub-dimensions: physical-social privacy (items 1-15) and psychological-information privacy (items 16-30) and the total It consists of 30 items. There are no items that need to be reversed in calculating the total scale score. The Cronbach Alpha reliability coefficient of the scale is 0.95 for the level of awareness section, 0.96 for the frequency of application section, 0.90 and 0.92 for the physical-social privacy sub-dimension, and 0.93 and 0.94 for the psychological-information privacy sub-dimension. was found as. The increase in the scores individuals receive from the scale indicates that their privacy awareness levels are high and their frequency of privacy-oriented practices is high.A minimum score of 30 and a maximum score of 150 is obtained from the scale.
Measured: 1 years
Empathy
Empathic Tendency Scale (EES): Empathic Tendency A validity and reliability study of the scale was conducted and the reliability coefficient was found to be 0.82. This is what was done In the study, the Cronbach alpha coefficient was determined as 0.75. Individuals express their agreement with the opinion in the relevant article by marking one of the numbers from 1 to 5 next to each item. The marked numbers constitute the scores for that item. The highest total score that can be obtained is 100 and the lowest score is 20. A high total score means that the empathic tendency is high. Some expressions in the empathic tendency scale are written negatively and reversed to prevent people from saying "yes". To avoid the tendency to say yes, the statements in the 3rd, 6th, 7th, 8th, 11th, 12th, 13th, 15th rows are written backwards. The scoring for these items is; It was determined as completely inappropriate (5 points) and completely appropriate (1 point).
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jan 2023
- Primary completion1 Feb 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SimulationStudies 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
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hediye KARAKOÇ, Study chair, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864859
- Sponsor's protocol ID
- KaratayUNIH3
- Acronym
- SCIENCE
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakoc H, Ozkan H. The effect of wearable simulated birth model on students' empathy and privacy protection levels: a randomised controlled trial. BMC Med Educ. 2026 Feb 5;26(1):383. doi: 10.1186/s12909-025-08441-8.
PubMed 41639700
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Birth Experience With a Wearable Simulated Motherhood Model on Empathic Tendency and Privacy Protection Level: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05864859
- Acronym / sponsor ID
- SCIENCE / KaratayUNIH3
- Conditions
- Simulation, Empathy
- Keywords
- Simulation, Empathy, Privacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 18 May 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.
Proving the empathy level and privacy protection effectiveness of the low-cost, high-reality and interactive education model constitutes the original value of the project and our main motivation. The project has a unique value for a sustainable future in terms of its impact at the social level in terms of midwifery students in particular and positive birth experience and qualified midwifery care in general. It will also provide data for the comparison of innovative education methods with traditional education methods. Thus, it will help to improve, regulate or build capacity of future initiatives.
Detailed description
Humanistic care is also conceptualized as the ability to communicate with patients, feel their emotions, meet their needs, and develop harmonious therapeutic relationships. Humanistic care is the essence and connotation of the care process. But developing a sense of humanistic care is quite difficult. Despite emphasizing humanistic care in midwifery education and making great efforts, its integration into professional practice is still not at the desired level .
Empathy refers to the tendency to recognize, help, and respond to other people's experiences and emotions. Empathy allows midwives to measure various situations, understand mothers' situation, perspective, feelings, and apply appropriate woman-centered care. It is stated that empathy can contribute to students' humanistic care skills both directly and indirectly through emotional intelligence.
Birth is one of the most private areas where privacy should be protected, and practices done during childbirth cause embarrassment in women, decrease the level of satisfaction and lead to a negative perception of childbirth. Healthcare professionals have both ethical and legal responsibilities regarding privacy. In order to fulfill their duties towards the individuals they care for, they need to protect the privacy of the individual. In a meta-analysis study examining the ethical decision-making process in care and practices, it was found that it is a difficult process to implement the ethical decision-making process and it is affected by many personal and situational factors.
The use of standardized patient or human actors in simulation practice was initiated in 1963 by a neurologist from the University of Southern California. It is stated that the use of standardized patient or human actors adds more realism to the simulation by allowing training in both procedural and communication skills. With the hybrid simulation, which allows the birth process to be animated as in real life, the human element in birth is preserved and the reality shock they will experience in real life is prevented. It is stated that it adds more realism and interaction thanks to psychological reactions, especially during a clinical event.
It is stated that the use of simulation reflection, role playing, pedagogical theater and real-life case studies should be included in the curriculum in midwifery programs. However, it is stated that there are limited studies with midwifery students. It is stated that the use of standardized patients is beneficial not only for learners, but also for standardized patients themselves. Therefore, it is suggested that more research is needed to examine the mutual benefits of using standardized patients in simulation practice. In this context, proving the empathy level and privacy protection effectiveness of the low-cost, high-reality and interactive education model in line with the literature proposal constitutes the original value of the project and our main motivation. The project has a unique value for a sustainable future in terms of its impact at the social level in terms of midwifery students in particular and positive birth experience and qualified midwifery care in general. It will also provide data for the comparison of innovative education methods with traditional education methods. Thus, it will help to improve, regulate or build capacity of future initiatives.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal birth group | Experimental | Other: SimulationIt consisted of preliminary information (10 minutes), practice (10 minutes) and analysis (20 minutes) sessions with groups of 2 people (1 midwife, 1 pregnant) accompanied by a scenario where there was no complication during labor. |
| Breech birth group | Experimental | Other: SimulationIt consisted of preliminary information (10 minutes), practice (10 minutes) and analysis (20 minutes) sessions with groups of 2 people (1 midwife, 1 pregnant) accompanied by a scenario that experienced complications during labor. |
| Control group | No intervention | –She continued her education in accordance with the (1+32) hour curriculum within the scope of the midwifery undergraduate program Integrated Practice I and EBE402 Integrated Practice II courses. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a final year midwifery student,
- Not being married
- To be nulliparous
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- Having the ability to read, listen, write, speak and understand Turkish,
- Repeating the course,
- Unwilling to withdraw from research
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 |
|---|---|---|
| SimulationIn the simulation session, while 2 participants (1 midwife, 1 pregnant) performed the roles in accordance with the clinical scenario, the performance was recorded in the control room. A Wearable Pregnancy Simulator was worn by the student performing the pregnant role. During the simulation, the participants were able to interact with the facilitators when they had questions. The application time did not exceed 10 minutes. | Other | Breech birth group, Normal birth group |
Primary outcome
Privacy
Time frame: 1 years
Privacy Protection Scale in Obstetrics and Gynecology: The scale has 2 sections: awareness level and application frequency, 2 sub-dimensions: physical-social privacy (items 1-15) and psychological-information privacy (items 16-30) and the total It consists of 30 items. There are no items that need to be reversed in calculating the total scale score. The Cronbach Alpha reliability coefficient of the scale is 0.95 for the level of awareness section, 0.96 for the frequency of application section, 0.90 and 0.92 for the physical-social privacy sub-dimension, and 0.93 and 0.94 for the psychological-information privacy sub-dimension. was found as. The increase in the scores individuals receive from the scale indicates that their privacy awareness levels are high and their frequency of privacy-oriented practices is high.A minimum score of 30 and a maximum score of 150 is obtained from the scale.
Empathy
Time frame: 1 years
Empathic Tendency Scale (EES): Empathic Tendency A validity and reliability study of the scale was conducted and the reliability coefficient was found to be 0.82. This is what was done In the study, the Cronbach alpha coefficient was determined as 0.75. Individuals express their agreement with the opinion in the relevant article by marking one of the numbers from 1 to 5 next to each item. The marked numbers constitute the scores for that item. The highest total score that can be obtained is 100 and the lowest score is 20. A high total score means that the empathic tendency is high. Some expressions in the empathic tendency scale are written negatively and reversed to prevent people from saying "yes". To avoid the tendency to say yes, the statements in the 3rd, 6th, 7th, 8th, 11th, 12th, 13th, 15th rows are written backwards. The scoring for these items is; It was determined as completely inappropriate (5 points) and completely appropriate (1 point).
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 8 Jul 2024.
- Derived from this study: PubMed 41639700Karakoc H, Ozkan H. The effect of wearable simulated birth model on students' empathy and privacy protection levels: a randomised controlled trial. BMC Med Educ. 2026 Feb 5;26(1):383. doi: 10.1186/s12909-025-08441-8.
- 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.
Hediye KARAKOÇ study chair
KTO Karatay 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 Simulation and Empathy, run by KTO Karatay 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 3 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 8 Jul 2024. 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?
Privacy (time frame: 1 years). 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 NCT05864859, which also lists 1 linked publication.
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 8 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.