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CompletedNCT04027933Updated Jul 22, 2019

Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder

An interventional study of Education Based on Standard Patient Simulation in Educational Problems, Anxiety and Fear and Nurse-Patient Relations, sponsored by Ankara Yildirim Beyazıt University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 17 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-22.

Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Sep 2017, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
17 Years to 25 Years
Sex
All
01

Study 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. 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?
  2. 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?
  3. 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?
  4. 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?
  5. 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.

02

Conditions studied

  • Educational Problems
  • Anxiety and Fear
  • Nurse-Patient Relations

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Keywords

  • Psychiatric nursing
  • Simulation
  • Standardized patients
03

In context

Anxiety Disorders

5,065 studies on the registry are indexed under Anxiety Disorders; 1,406 are open to participants now.

This study's enrollment of 83 is close to the median of 80 across 4,341 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 238 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Volunteer Students

Exclusion criteria

Exclusion Criteria:

  • Foreign National Students
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
83 participants (actual)

Study arms

  • Active comparator
    Experimental

    Education Based on Standard Patient Simulation was given to this group

    Behavioral: Education Based on Standard Patient Simulation

  • No intervention
    Control

    Control group

Interventions

  • BehavioralEducation Based on Standard Patient Simulation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from fear and behavioral intentions of the students at 2 months.

  2. 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.

    Time frame: Change from communication skills assessment scale of the students at 2 months.

  3. 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.

    Time frame: Change from the state and trait anxiety level of the students at 2 months.

  4. 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.

    Time frame: Change from the self-efficacy - sufficiency scale of the students at 2 months.

  5. 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.

    Time frame: Change from the clinical decision making in the nursing scale of the students at 2 months.

07

Study locations

1 site
  • Ankara Yıldırım Beyazıt Universty, Faculty Of Health Sciences, Department Nursing, Mental health and Nursing
    Ankara, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Nov 2017, 1 month.

Of 2,724 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 1 month is below that.

Counting every sponsor, half of 2,793 studies reached it within 12 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2019
First posted
Jul 22, 2019
StartActual
Sep 28, 2017
Primary completionActual
Nov 23, 2017
CompletionActual
Nov 23, 2017
Last update
Jul 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04027933
Responsible party
Nesibe Gunay Molu (Director, Nursing Department, Principal Investigator and Phd student, Ankara Yildirim Beyazıt University) — Principal investigator
First posted
Jul 22, 2019
Start date
Sep 28, 2017
Primary completion
Nov 23, 2017
Completion
Nov 23, 2017
Last update
Jul 22, 2019

Study contacts

Birgül Özkan, Assoc. Prof
study director · Ankara Yildirim Beyazıt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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