HealthyNCT06572020
The Effect of Simulation-Based Training on Physiotherapy Student's Self-Confidence and Satisfaction Level
A study testing education in people with Healthy and Simulation of Physical Illness, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the effect of simulation-based training in the cardiac rehabilitation course on the confidence and satisfaction of physiotherapy and rehabilitation students. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Simulation of Physical Illness, Blood Pressure
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Aug 2024to 26 Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a student of Physiotherapy and Rehabilitation at Acıbadem University
- Being enrolled in the Cardiac Diseases and Rehabilitation course
- Having completed the consent form
Who cannot join
- Repeating the Cardiac Diseases and Rehabilitation course
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul, Ataşehir, 34752
Sema Savci, Professor, +905326944647, sema.savci@acibadem.edu.tr
About this study
Official title: The Effect of Simulation-Based Blood Pressure and Electrocardiography Training in Cardiac Rehabilitation on Physiotherapy Student's Self-Confidence and Satisfaction Level
The goal of this clinical trial is to investigate the effect of simulation-based training in the cardiac rehabilitation course on the confidence and satisfaction of physiotherapy and rehabilitation students.
The main questions it aims to answer are:
Read more
Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the confidence levels of physiotherapy students? Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the satisfaction levels of physiotherapy students? Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the theoretical knowledge levels of physiotherapy students?
This study is planned to be conducted with 39 individuals who are enrolled in the course and taking it for the first time.
The study will be conducted at the Acıbadem University CASE Laboratory using surveys administered before and after simulation training on blood pressure and electrocardiography (ECG). The sociodemographic characteristics of the participants will be recorded using an information form. The level of experience, theoretical knowledge, and competency in blood pressure and ECG measurement will be assessed with a 'Pre-Test' prepared for this purpose. The same parameters, along with satisfaction with the simulation training, will be assessed with a 'Post-Test' using a self-assessment survey method after the training. The prepared surveys, detailed below, will be completed separately for blood pressure and ECG training.
- Conditions
- Healthy, Simulation of Physical Illness, Blood Pressure
- Being tested
- education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
simulation-based training on blood pressure and ECG measurement
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy students | Experimental | Physiotherapy students Receives: Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Satisfaction and Self-Confidence in Learning
The 'Student Satisfaction and Confidence Scale in Learning' will be administered separately for blood pressure and ECG training at the end of the simulation. The original 13-item scale by Jeffries and Rizzolo (2006) was adapted into Turkish with 12 items. It uses a 5-point Likert scale and includes two subscales: 'Satisfaction with Current Learning' (5 items) and 'Confidence in Learning' (7 items), with no negative items. Scores are obtained by averaging subscale scores. Higher total scores indicate greater satisfaction and confidence. Item 13 was recommended for exclusion by Franklin et al., re-evaluated by language experts, and removed by the research group. Therefore, the 12-item version will be used in our study
Measured: One day (The assessments will be conducted once)
Secondary outcomes (2)
Practitioner Competency Test
The 'Practitioner Competency Test' in the pre-test includes 5 questions
Questions are:
How confident are you in performing blood pressure measurements? How prepared do you feel for performing blood pressure measurements? How adequate is your practical knowledge for blood pressure measurements? How accurate do you think your blood pressure measurements are? How functional is the theoretical training received on blood pressure measurement during practice?
These questions use a Visual Analog Scale for responses. Additionally, participants will answer statements about their confidence and knowledge in ECG skills using a 5-point Likert scale:
"I feel confident in my ECG assessment skills." "I believe my practical knowledge for ECG application is sufficient." "I think I correctly assess ischemia and necrosis on an ECG." "I feel confident in ECG evaluation." "I find the theoretical training I received on ECG to be functional during practical application."
Measured: One day (The assessments will be conducted once)
Theoretical Knowledge Level Assessment Test
The pre-test, prepared by the researchers and to be completed by all students before the simulation training, consists of a section called 'Theoretical Knowledge Level Assessment Test.' This section includes 3 open-ended questions designed to measure theoretical knowledge about blood pressure and ECG.
The questions for blood pressure and ECG are as follows:
What are the names of the first and last sounds heard during blood pressure measurement? What do these sounds signify? What are the normal blood pressure values in adults? Which artery is typically used for blood pressure measurement? What waves make up a normal ECG? What is the change seen on an ECG in myocardial ischemia? What are the changes seen on an ECG in myocardial infarction (necrosis)?
Measured: One day (The assessments will be conducted once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start26 Aug 2024
- Primary completion26 Sep 2024 (estimated)
- Study completion26 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572020
- Sponsor's protocol ID
- ACU-CASE-1
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Blood Pressure and Electrocardiography Training in Cardiac Rehabilitation on Physiotherapy Student's Self-Confidence and Satisfaction Level
- ClinicalTrials.gov ID
- NCT06572020
- Acronym / sponsor ID
- ACU-CASE-1
- Conditions
- Healthy, Simulation of Physical Illness, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 26 Sep 2024 (estimated)
- Study completion
- 26 Sep 2024 (estimated)
- First posted
- 26 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.
The goal of this clinical trial is to investigate the effect of simulation-based training in the cardiac rehabilitation course on the confidence and satisfaction of physiotherapy and rehabilitation students.
The main questions it aims to answer are:
Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the confidence levels of physiotherapy students? Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the satisfaction levels of physiotherapy students? Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the theoretical knowledge levels of physiotherapy students?
This study is planned to be conducted with 39 individuals who are enrolled in the course and taking it for the first time.
The study will be conducted at the Acıbadem University CASE Laboratory using surveys administered before and after simulation training on blood pressure and electrocardiography (ECG). The sociodemographic characteristics of the participants will be recorded using an information form. The level of experience, theoretical knowledge, and competency in blood pressure and ECG measurement will be assessed with a 'Pre-Test' prepared for this purpose. The same parameters, along with satisfaction with the simulation training, will be assessed with a 'Post-Test' using a self-assessment survey method after the training. The prepared surveys, detailed below, will be completed separately for blood pressure and ECG training.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy students | Experimental | Other: educationPhysiotherapy students |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being a student of Physiotherapy and Rehabilitation at Acıbadem University
- Being enrolled in the Cardiac Diseases and Rehabilitation course
- Having completed the consent form
Key exclusion criteria (2 listed)
- Repeating the Cardiac Diseases and Rehabilitation course
- Refusing to participate in the study
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 |
|---|---|---|
| educationsimulation-based training on blood pressure and ECG measurement | Other | Physiotherapy students |
Primary outcome
Student Satisfaction and Self-Confidence in Learning
Time frame: One day (The assessments will be conducted once)
The 'Student Satisfaction and Confidence Scale in Learning' will be administered separately for blood pressure and ECG training at the end of the simulation. The original 13-item scale by Jeffries and Rizzolo (2006) was adapted into Turkish with 12 items. It uses a 5-point Likert scale and includes two subscales: 'Satisfaction with Current Learning' (5 items) and 'Confidence in Learning' (7 items), with no negative items. Scores are obtained by averaging subscale scores. Higher total scores indicate greater satisfaction and confidence. Item 13 was recommended for exclusion by Franklin et al., re-evaluated by language experts, and removed by the research group. Therefore, the 12-item version will be used in our study
2 secondary outcomes
Practitioner Competency Test
Time frame: One day (The assessments will be conducted once)
Theoretical Knowledge Level Assessment Test
Time frame: One day (The assessments will be conducted once)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Healthy and Simulation of Physical Illness, run by Acibadem 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 3 inclusion and 2 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 20 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yağmur Küçük (+905433927630, yagmur.kucuk@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student Satisfaction and Self-Confidence in Learning (time frame: One day (The assessments will be conducted once)). 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 20 Sep 2024.