NCT04027933

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

  1. 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. 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. 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. 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

July 2, 2019

Last Update Submit

July 19, 2019

Conditions

Keywords

Psychiatric nursingSimulationStandardized patients

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

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

Study Arms (2)

Experimental

ACTIVE COMPARATOR

Education Based on Standard Patient Simulation was given to this group

Behavioral: Education Based on Standard Patient Simulation

Control

NO INTERVENTION

Control group

Interventions

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.

Experimental

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Volunteer Students

You may not qualify if:

  • Foreign National Students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Birgül Özkan, Assoc. Prof

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor does not know which group the data belongs to.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two parallel group pretest-poshest randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Nursing Department, Principal Investigator and Phd student

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 22, 2019

Study Start

September 28, 2017

Primary Completion

November 23, 2017

Study Completion

November 23, 2017

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations