search
Back to results

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

Primary Purpose

Educational Problems, Anxiety and Fear, Nurse-Patient Relations

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education Based on Standard Patient Simulation
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Educational Problems focused on measuring Psychiatric nursing, Simulation, Standardized patients

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Volunteer Students

Exclusion Criteria:

• Foreign National Students

Sites / Locations

  • Ankara Yıldırım Beyazıt Universty, Faculty Of Health Sciences, Department Nursing, Mental health and Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Experimental

Control

Arm Description

Education Based on Standard Patient Simulation was given to this group

Control group

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
July 19, 2019
Sponsor
Ankara Yildirim Beyazıt University
search

1. Study Identification

Unique Protocol Identification Number
NCT04027933
Brief Title
Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder
Official Title
An Examination of the Education Based on Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder: Randomized Controlled Research
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
November 23, 2017 (Actual)
Study Completion Date
November 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Educational Problems, Anxiety and Fear, Nurse-Patient Relations
Keywords
Psychiatric nursing, Simulation, Standardized patients

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel group pretest-poshest randomized control trial
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor does not know which group the data belongs to.
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Active Comparator
Arm Description
Education Based on Standard Patient Simulation was given to this group
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Education Based on Standard Patient Simulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fear and Behavior Intent Scale
Description
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.
Title
The Communication Skills Assessment Scale
Description
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.
Title
State and Trait Anxiety Level
Description
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.
Title
Self-Efficacy - Sufficiency Scale
Description
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.
Title
Clinical Decision Making in The Nursing Scale
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Volunteer Students Exclusion Criteria: • Foreign National Students
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgül Özkan, Assoc. Prof
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Study Director
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt Universty, Faculty Of Health Sciences, Department Nursing, Mental health and Nursing
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs