Anxiety LevelNCT06556524
The Effect of Live Subject on the Anxiety Level and Perceived Competence Level
An observational study of Anxiety Level, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out to examine the effect of training on the proficiency and anxiety levels of Paramedic students in a realistic, simulated environment of the pre-hospital scene. A total of 72 second-year students in the Paramedic program participated in this study with an interventional approach. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Level
- What is being tested?
- observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 31 Dec 2022
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: vocational school student
Who may be able to join
- volunteering
Who cannot join
- non volunteering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation Practice With a Live Subject on the Anxiety Level and Perceived Competence Level of Paramedic Candidates in Approaching a Trauma Patient
This study was carried out to examine the effect of training on the proficiency and anxiety levels of Paramedic students in a realistic, simulated environment of the pre-hospital scene. A total of 72 second-year students in the Paramedic program participated in this study with an interventional approach. The data collection form used in the study consisted of sociodemographic characteristics, a self-efficacy form for approaching trauma patients, and the worry and anxiety scale. Within the framework of the research, a competition named "trauma rally" was organized for university Paramedic students, which consisted of the pre-hospital approach of injured live subjects. Through face-to-face interviews, the data collection form was filled out with the participants before, immediately after and one month after the competition.
Read the detailed description
Teaching-learning strategies are methods to make it easier for the student to achieve professional goals in personal development. In the context of the academic education of healthcare professionals, ethical issues, patient safety, technological developments, health science, complexity of care measurements and current business world necessities should be taken into account by considering these strategies. In this context, simulation-based learning is one of the most effective and interesting teaching strategies and has been shown to reduce gaps between education and practice and adapt nursing students to clinical environments. Simulation is a set of structured activities that represent actual or potential situations in training and practice. These activities allow participants to develop or increase their knowledge, skills and attitudes, or to analyze and respond to realistic situations in a simulated environment. Simulations are especially important in clinical environments because they imitate various aspects of the real world and provide safe learning environments where students can practice until they reach skill competence through self-correction. As a matter of fact, the European heart association (ERC) points out that simulation programs increase the quality of trauma and advanced life support training and increase resuscitation rates after cardiac arrest. High fidelity simulation-based training can be an important component in preparing students for a successful transition into clinical practice. Additionally, it contributes to student satisfaction, confidence, competence and reduced anxiety levels. For these reasons, simulated experiences may be an option to complement traditional healthcare professional education methods.
- Conditions
- Anxiety Level
- Being tested
- observation
- Keywords
- Simulation, Paramedic, Anxiety, Competence
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationBehavioural
Behavioral observation and trauma measurement in live mannequin application
| Study group | Role | What they receive |
|---|---|---|
| twenty four Group | vocational school students Receives: Behavioral: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety level and trauma cases
As a result, it was determined that simulation training with a live subject did not change the anxiety level of paramedic candidates, but increased their self-efficacy against trauma cases, and that there was a negative relationship between anxiety scores and self-efficacy scores. Considering that interventions on patients and injured people in the pre-hospital scene are critical, it is recommended that simulation methods be combined with traditional methods in paramedic training.
Measured: fifteen days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Dec 2022
- Primary completion16 Dec 2022
- Study completion31 Dec 2022
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 Anxiety LevelStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sariye Bilge DOGAN, Gazi University
- Investigators
- Sariye Bilge Doğan, M.Sc, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556524
- Sponsor's protocol ID
- E-77082166-604.01.02-300721
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee BO, Liang HF, Chu TP, Hung CC. Effects of simulation-based learning on nursing student competences and clinical performance. Nurse Educ Pract. 2019 Nov;41:102646. doi: 10.1016/j.nepr.2019.102646. Epub 2019 Oct 23.
PubMed 31698255
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation Practice With a Live Subject on the Anxiety Level and Perceived Competence Level of Paramedic Candidates in Approaching a Trauma Patient
- ClinicalTrials.gov ID
- NCT06556524
- Acronym / sponsor ID
- E-77082166-604.01.02-300721
- Conditions
- Anxiety Level
- Keywords
- Simulation, Paramedic, Anxiety, Competence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Aug 2024 (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 carried out to examine the effect of training on the proficiency and anxiety levels of Paramedic students in a realistic, simulated environment of the pre-hospital scene. A total of 72 second-year students in the Paramedic program participated in this study with an interventional approach. The data collection form used in the study consisted of sociodemographic characteristics, a self-efficacy form for approaching trauma patients, and the worry and anxiety scale. Within the framework of the research, a competition named "trauma rally" was organized for university Paramedic students, which consisted of the pre-hospital approach of injured live subjects. Through face-to-face interviews, the data collection form was filled out with the participants before, immediately after and one month after the competition.
Detailed description
Teaching-learning strategies are methods to make it easier for the student to achieve professional goals in personal development. In the context of the academic education of healthcare professionals, ethical issues, patient safety, technological developments, health science, complexity of care measurements and current business world necessities should be taken into account by considering these strategies. In this context, simulation-based learning is one of the most effective and interesting teaching strategies and has been shown to reduce gaps between education and practice and adapt nursing students to clinical environments. Simulation is a set of structured activities that represent actual or potential situations in training and practice. These activities allow participants to develop or increase their knowledge, skills and attitudes, or to analyze and respond to realistic situations in a simulated environment. Simulations are especially important in clinical environments because they imitate various aspects of the real world and provide safe learning environments where students can practice until they reach skill competence through self-correction. As a matter of fact, the European heart association (ERC) points out that simulation programs increase the quality of trauma and advanced life support training and increase resuscitation rates after cardiac arrest. High fidelity simulation-based training can be an important component in preparing students for a successful transition into clinical practice. Additionally, it contributes to student satisfaction, confidence, competence and reduced anxiety levels. For these reasons, simulated experiences may be an option to complement traditional healthcare professional education methods.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| twenty four Group | – | Behavioral: observationvocational school students |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- vocational school student
Key inclusion criteria (1 listed)
- volunteering
Key exclusion criteria (1 listed)
- non volunteering
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 |
|---|---|---|
| observationBehavioral observation and trauma measurement in live mannequin application | Behavioural | twenty four Group |
Primary outcome
anxiety level and trauma cases
Time frame: fifteen days
As a result, it was determined that simulation training with a live subject did not change the anxiety level of paramedic candidates, but increased their self-efficacy against trauma cases, and that there was a negative relationship between anxiety scores and self-efficacy scores. Considering that interventions on patients and injured people in the pre-hospital scene are critical, it is recommended that simulation methods be combined with traditional methods in paramedic training.
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 16 Aug 2024.
- Results publication: PubMed 31698255Lee BO, Liang HF, Chu TP, Hung CC. Effects of simulation-based learning on nursing student competences and clinical performance. Nurse Educ Pract. 2019 Nov;41:102646. doi: 10.1016/j.nepr.2019.102646. Epub 2019 Oct 23.
- 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.
Sariye Bilge Doğan, M.Sc study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Level, run by Gazi 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: finished, as of the sponsor's last update on 16 Aug 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?
anxiety level and trauma cases (time frame: fifteen days). 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 NCT06556524, 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 16 Aug 2024.