NCT05504824

Brief Summary

Aim: This study was conducted to determine the effect of case-based education on the development of clinical reasoning skills of nursing students in critical illnesses. Methods: The study was conducted between January 20 and June 30, 2021 using a pilot randomized controlled trial design. In the study, 22 volunteer students were assigned to the experimental and control groups by simple randomization. The experimental group was given case-based education to improve their clinical reasoning skills, and the control group continued the standard education process. Data were collected using a Student Information Form, the Clinical Reasoning Case Form (CRCF), the Student Satisfaction with Education Questionnaire, and a Form for Views on the Education. In the evaluation of data, frequency values, Fisher exact test, Mann-Whitney U, and Wilcoxon tests, Cohen's d coefficient for effect size, ITT analysis, and covariance analysis were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

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

May 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

August 4, 2022

Last Update Submit

August 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Student Information Form

    This form consists of 9 questions, including students' nicknames, age, gender, duration of clinical experience, level of school success, and views on the nursing process

    The measurement was collected one week before education.

  • Clinical Reasoning Case Form (CRCF)

    There were 10 clinical cases on the CRCF prepared for the objectives of these three steps in students' clinical reasoning process. The cases involved critical illness, and early warning findings that show worsening in critical illness and are used to determine priority nursing diagnosis. Five people, who were experts in the field of medical nursing and had clinical experience, were consulted between February 15 and 28, 2021 to confirm the clinical accuracy and reality of CR cases and their content and comprehensibility. The content validity index of expert opinions evaluated with the Davis technique was determined as 1.

    The first measurement was collected one week before education. The second measurement was collected 3 weeks after education.

Secondary Outcomes (2)

  • Student Satisfaction with Education Questionnaire

    The measurement was collected 3 weeks after education.

  • Form for Views on the Education

    The measurement was collected 3 weeks after education.

Study Arms (2)

Experimental group

EXPERIMENTAL

Students in both experimental groups were applied the student information form and the pretest of the CRCF between May 18 and 20, 2021 before the education. The schedule of the education intervention was determined according to the convenience of the students in the experimental group. Accordingly, the experimental group was given education between June 8 and 11, 2021. After the education sessions were completed, experimental groups were applied the CRCF as a posttest on June 28, 2021. The students in the experimental group were asked to fill out the "Student Satisfaction with Education Questionnaire" and the "Form for Views on the Education" online.

Other: Case-based education

Control group

NO INTERVENTION

Students in control groups were applied the student information form and the pretest of the CRCF between May 18 and 20, 2021 before the education. The students in the control group continued their current standard education process. After the education sessions were completed, control groups were applied the CRCF as a posttest on June 28, 2021.

Interventions

The education phase This stage included the explanation of the CR process, the analysis of CR cases, the drafting of new cases suitable for the CR process by students, and the analysis process. The education program was carried out on a web platform (Zoom) consistent with the changes in the COVID-19 pandemic process. The CR cases to be used in case-based education were sent to the students via e-mail before the group interview to make sure students came prepared for the group discussion. In case-based education, after the students read the case, they were asked some questions to determine their decisions and reasoning.

Experimental group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having completed the "Medical Nursing" and Surgical Nursing" courses,
  • Volunteering to participate in the study,
  • Participate in "Case-Based Education"

You may not qualify if:

  • Not being willing to participate in the study,
  • Abandoning the "Case-Based Education" practice
  • Not taking one or two of the "Medical Nursing" and "Surgical Nursing" courses at all, or to have taken them but unsuccessfully

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Nursing

Ankara, 06230, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 17, 2022

Study Start

May 18, 2021

Primary Completion

June 28, 2021

Study Completion

June 30, 2021

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations