Educational ProblemsNCT04027933
Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder
A study testing Education Based on Standard Patient Simulation in people with Educational Problems and Anxiety and Fear, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of the simulation method with the participation of standardized patients towards the patients suffering from bipolar disorder to benefit the education of the psychiatry nursing students. The Research Questions 1. Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Anxiety and Fear, Nurse-Patient Relations
- What is being tested?
- Education Based on Standard Patient Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2017to 23 Nov 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 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Volunteer Students
Who cannot join
- Foreign National Students
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt Universty, Faculty Of Health Sciences, Department Nursing, Mental health and Nursing
Ankara
About this study
Official title: An Examination of the Education Based on Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder: Randomized Controlled Research
The study was conducted to determine the effect of the simulation method with the participation of standardized patients towards the patients suffering from bipolar disorder to benefit the education of the psychiatry nursing students.
The Research Questions
- Does the use of simulation training with the standardized patients have any effect on the average scores of the fear and behavioral intentions of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the communication skills assessment scale of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the state and trait anxiety level of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the clinical decision making in the nursing scale of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the self-efficacy - sufficiency scale of the students as they approach patients with bipolar disorder?
Read the detailed description
The students of the Department of Nursing in the Faculty of Health Sciences at Ankara's Yıldırım Beyazıt University during the 2017-2018 academic year constitute the research universe. The research universe was randomly selected from the students who voluntarily accepted to participate in the research and met the research criteria. The Minitab software was used to calculate samples and 99% confidence interval with type 1 error 0.05 was accepted. A 0.5 score difference of the anxiety scale was accepted as a success and a sample of 76 students with 38 in the experimental and 38 in the control group was agreed upon. This calculation was based on the change in the anxiety scale score after the simulation education in Kameg et al.'s 2014 study. The power analysis at the end of the study indicated that the scale's average scores ranged between 0.56-0.98. Foreign national students were not included in the study in order to generate a common language. 83 students who will be trainees in the psychiatric clinics and community mental health centers (CMHC) were included in the study and constituted the experimental and control groups. Female and male students were ranked from the highest to the lowest by their academic success scores, and random numbers were assigned in excel to randomly divide these ranked students among the groups. This randomization procedure was done in class. Numbers greater than 0.5 were assigned to the experimental group and numbers lower than 0.5 were assigned to the control group.
Before the study began, two students whose clinical practice locations had changed and two students who were absent in the theoretical class were excluded from the study, and 79 students were divided into two groups as 40 students for the experimental and 39 students for the control group. In the experimental group, 2 students who were absent in the simulation practice and one student who did not properly fill out the data collection form were excluded from the study. In the control group, two students who did not want to fill out the data collection form were also excluded from the study. The study was completed with 37 students from experimental group and 37 from the control group - 74 individuals in total.
Data Evaluation The research data was evaluated in SPSS 22.0 statistical software as appropriate to the quality of the data and research. Normality analysis was conducted by Kolmogorov Smirnov, Shapiro-Wilk, skewness and kurtosis values.
To evaluate the impact size of the education program, variance analysis was used in the repeating assessment. In this study, the impact size of the education was found 1.45≤, and evaluated as very high levels.
- Being tested
- Education Based on Standard Patient Simulation
- Keywords
- Psychiatric nursing, Simulation, Standardized patients
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Based on Standard Patient SimulationBehavioural
In the first phase of the study, a theoretical education was provided to the students.
In the second phase, the students in the experimental and control groups who completed their theoretical education were given data collection forms. In the third phase, after the scales were implemented, there was no intervention with the control group. There was a standard patient implementation to the experimental group. In the fourth phase of the study, after completing the simulation practice, all scales were re-applied both to the experimental and control groups. The scales were applied after the simulation training was completed and students were sent to the clinical practice after three weeks. In the fourth phase of the study, right before the students practiced their trainings and at the end of the initial rotations of the clinical practice, which turned out to be about four weeks later on average, all scales were re-applied both to the experimental and control groups.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | Education Based on Standard Patient Simulation was given to this group Receives: Behavioral: Education Based on Standard Patient Simulation |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear and Behavior Intent Scale
The scale, developed by Wolf (1996) measures fear and behavioral attitudes toward mentally disordered patients. The scale was adapted into Turkish by Günay Molu and Özkan after the required permission was taken from the e-mail address on the original article (Günay Molu and Özkan 2018). It is a 5-Likert type scale including ten items, and each item is graded between 1-5. An change in the total score of the scale means an change in negative attitudes towards the mentally disordered patient. Cronbach's alpha was 0.784.
Measured: Change from fear and behavioral intentions of the students at 2 months.
The Communication Skills Assessment Scale
The 5-Likert type scale developed by Korkut (1996) is scored from "always" to "never". The scale consists of 25 items in total, and the maximum possible score is 100 while zero is the minimum. Higher scores indicate better communication skills. The reliability coefficient is .76 and the alpha internal consistency coefficient is .80.
Measured: Change from communication skills assessment scale of the students at 2 months.
State and Trait Anxiety Level
The scale developed by Spielberger in 1970 is a self-assessment questionnaire which is used to define state and trait anxiety levels. It was adapted into Turkish by Öner and Le Compte in 1985. It is a 4-Likert type scale. The scores of both scales range from 20 to 80 in total (Oner, 1992). It is reported that the Alpha's coefficient ranges between .83 and .87, while the test re-test reliability ranges between .71 and .86, and the item reliability ranges between .34 and .72.
Measured: Change from the state and trait anxiety level of the students at 2 months.
Self-Efficacy - Sufficiency Scale
The scale developed by Sherer et al. (1982) and adapted into Turkish by Gözüm and Aksayan (1999) was developed to assess behavior and behavioral changes. It is a 23 item 5-Likert type self-assessment scale. Its score ranges between 23 and 115. Higher scores mean that the individual has higher SES perception (Gözüm and Aksayan, 1999). The reliability and validity of the Turkish version was done for the same sample, and the Cronbach's alpha internal consistency coefficient was found to be .81, and the test re-test reliability was .92.
Measured: Change from the self-efficacy - sufficiency scale of the students at 2 months.
Clinical Decision Making in The Nursing Scale
The scale developed by Jenkins (1983) defines the clinical decision making perceptions of nursing students. The original scale consists of 40 items and four sub-scales. Each sub-scale consists of 10 items. Total score ranges between 40 and 200, and each subscale ranges between 10 and 50 with no cut-off point. Total Cronbach's alpha reliability coefficient is 0.78.
Measured: Change from the clinical decision making in the nursing scale of the students at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start28 Sep 2017
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel group pretest-poshest randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesibe Gunay Molu, Ankara Yildirim Beyazıt University
- Investigators
- Birgül Özkan, Assoc. Prof, Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027933
- Sponsor's protocol ID
- Nesibe GUNAY MOLU
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of the Education Based on Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder: Randomized Controlled Research
- ClinicalTrials.gov ID
- NCT04027933
- Acronym / sponsor ID
- Nesibe GUNAY MOLU
- Keywords
- Psychiatric nursing, Simulation, Standardized patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 22 Jul 2019 (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 study was conducted to determine the effect of the simulation method with the participation of standardized patients towards the patients suffering from bipolar disorder to benefit the education of the psychiatry nursing students.
The Research Questions
- Does the use of simulation training with the standardized patients have any effect on the average scores of the fear and behavioral intentions of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the communication skills assessment scale of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the state and trait anxiety level of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the clinical decision making in the nursing scale of the students as they approach patients with bipolar disorder?
- Does the use of simulation training with the standardized patients have any effect on the average scores of the self-efficacy - sufficiency scale of the students as they approach patients with bipolar disorder?
Detailed description
The students of the Department of Nursing in the Faculty of Health Sciences at Ankara's Yıldırım Beyazıt University during the 2017-2018 academic year constitute the research universe. The research universe was randomly selected from the students who voluntarily accepted to participate in the research and met the research criteria. The Minitab software was used to calculate samples and 99% confidence interval with type 1 error 0.05 was accepted. A 0.5 score difference of the anxiety scale was accepted as a success and a sample of 76 students with 38 in the experimental and 38 in the control group was agreed upon. This calculation was based on the change in the anxiety scale score after the simulation education in Kameg et al.'s 2014 study. The power analysis at the end of the study indicated that the scale's average scores ranged between 0.56-0.98. Foreign national students were not included in the study in order to generate a common language. 83 students who will be trainees in the psychiatric clinics and community mental health centers (CMHC) were included in the study and constituted the experimental and control groups. Female and male students were ranked from the highest to the lowest by their academic success scores, and random numbers were assigned in excel to randomly divide these ranked students among the groups. This randomization procedure was done in class. Numbers greater than 0.5 were assigned to the experimental group and numbers lower than 0.5 were assigned to the control group.
Before the study began, two students whose clinical practice locations had changed and two students who were absent in the theoretical class were excluded from the study, and 79 students were divided into two groups as 40 students for the experimental and 39 students for the control group. In the experimental group, 2 students who were absent in the simulation practice and one student who did not properly fill out the data collection form were excluded from the study. In the control group, two students who did not want to fill out the data collection form were also excluded from the study. The study was completed with 37 students from experimental group and 37 from the control group - 74 individuals in total.
Data Evaluation The research data was evaluated in SPSS 22.0 statistical software as appropriate to the quality of the data and research. Normality analysis was conducted by Kolmogorov Smirnov, Shapiro-Wilk, skewness and kurtosis values.
To evaluate the impact size of the education program, variance analysis was used in the repeating assessment. In this study, the impact size of the education was found 1.45≤, and evaluated as very high levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel group pretest-poshest randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Behavioral: Education Based on Standard Patient SimulationEducation Based on Standard Patient Simulation was given to this group |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Volunteer Students
Key exclusion criteria (1 listed)
- Foreign National Students
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 |
|---|---|---|
| Education Based on Standard Patient SimulationIn the first phase of the study, a theoretical education was provided to the students. In the second phase, the students in the experimental and control groups who completed their theoretical education were given data collection forms. In the third phase, after the scales were implemented, there was no intervention with the control group. There was a standard patient implementation to the experimental group. In the fourth phase of the study, after completing the simulation practice, all scales were re-applied both to the experimental and control groups. The scales were applied after the simulation training was completed and students were sent to the clinical practice after three weeks. In the fourth phase of the study, right before the students practiced their trainings and at the end of the initial rotations of the clinical practice, which turned out to be about four weeks later on average, all scales were re-applied both to the experimental and control groups. | Behavioural | Experimental |
Primary outcome
Fear and Behavior Intent Scale
Time frame: Change from fear and behavioral intentions of the students at 2 months.
The scale, developed by Wolf (1996) measures fear and behavioral attitudes toward mentally disordered patients. The scale was adapted into Turkish by Günay Molu and Özkan after the required permission was taken from the e-mail address on the original article (Günay Molu and Özkan 2018). It is a 5-Likert type scale including ten items, and each item is graded between 1-5. An change in the total score of the scale means an change in negative attitudes towards the mentally disordered patient. Cronbach's alpha was 0.784.
The Communication Skills Assessment Scale
Time frame: Change from communication skills assessment scale of the students at 2 months.
The 5-Likert type scale developed by Korkut (1996) is scored from "always" to "never". The scale consists of 25 items in total, and the maximum possible score is 100 while zero is the minimum. Higher scores indicate better communication skills. The reliability coefficient is .76 and the alpha internal consistency coefficient is .80.
State and Trait Anxiety Level
Time frame: Change from the state and trait anxiety level of the students at 2 months.
The scale developed by Spielberger in 1970 is a self-assessment questionnaire which is used to define state and trait anxiety levels. It was adapted into Turkish by Öner and Le Compte in 1985. It is a 4-Likert type scale. The scores of both scales range from 20 to 80 in total (Oner, 1992). It is reported that the Alpha's coefficient ranges between .83 and .87, while the test re-test reliability ranges between .71 and .86, and the item reliability ranges between .34 and .72.
Self-Efficacy - Sufficiency Scale
Time frame: Change from the self-efficacy - sufficiency scale of the students at 2 months.
The scale developed by Sherer et al. (1982) and adapted into Turkish by Gözüm and Aksayan (1999) was developed to assess behavior and behavioral changes. It is a 23 item 5-Likert type self-assessment scale. Its score ranges between 23 and 115. Higher scores mean that the individual has higher SES perception (Gözüm and Aksayan, 1999). The reliability and validity of the Turkish version was done for the same sample, and the Cronbach's alpha internal consistency coefficient was found to be .81, and the test re-test reliability was .92.
Clinical Decision Making in The Nursing Scale
Time frame: Change from the clinical decision making in the nursing scale of the students at 2 months.
The scale developed by Jenkins (1983) defines the clinical decision making perceptions of nursing students. The original scale consists of 40 items and four sub-scales. Each sub-scale consists of 10 items. Total score ranges between 40 and 200, and each subscale ranges between 10 and 50 with no cut-off point. Total Cronbach's alpha reliability coefficient is 0.78.
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 22 Jul 2019.
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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.
Birgül Özkan, Assoc. Prof study director
Ankara Yildirim Beyazıt 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 Education Based on Standard Patient Simulation in people with Educational Problems and Anxiety and Fear, run by Ankara Yildirim Beyazıt 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 22 Jul 2019. 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?
Fear and Behavior Intent Scale (time frame: Change from fear and behavioral intentions of the students at 2 months.). The study lists 5 primary outcomes in all. 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 22 Jul 2019.