Serious Game On Stoma Care Education For Nursing Students

January 23, 2024 updated by: Nursen Kulakac, Gümüşhane Universıty

Effect Of Serious Game-Based Web Application On Stoma Care Education For Nursing Students

Today, rapidly developing technology needs to be integrated into teaching environments and reconstructed teaching environments. When virtual reality applications, which are among the popular and innovative technologies, are examined, it is seen that participants are used in many areas of education. In this randomized controlled study, it was aimed to evaluate the impact of stoma care education by designing a serious game based web application that enables nursing students to gain skills and practice in psychomotor applications. The universe of the study will be students enrolled in the Surgical Diseases Nursing course in the spring semester of the 2020-2021 academic year at the Faculty of Health Sciences, Gümüşhane University. Students will be divided into two groups as control and experiment by randomization method. The data will be collected through introductory features form, 'Stoma Care Information Form', 'Stoma Care Skill Checklist' and Computer System Usability Survey. In the first stage of the study, the students will be given a 'Stoma Care Information Form' (first knowledge). 'Stoma Care Information Form' (second information) and 'Stoma Care Skill Checklist' will be applied after completing the theoretical lesson of stoma care and group work in the laboratory of students in the experimental and control groups. Unlike the control group, of students in the experimental group; A serious game-based web application on stoma care prepared as a support for formal education will be installed. After four weeks of the students attending formal education, 'Stoma Care Information Form' (third knowledge) and 'Stoma Care Skill Checklist' (second skill) will be applied. In the experiment and control group, two weeks later, the "Stoma Care Information Form" (fourth information) and "Stoma Care Skill Checklist" (third skill) will be applied again to test the permanence of the methods. Skill measurements of students will be made with an objective structured clinical exam. The results obtained after the application will be analyzed and the impact of serious game based web application on stoma care education will be determined

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gumushane, Turkey, 29100
        • Nurşen Kulakaç

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Enrolling in the HEMSEC-217 Emergency Nursing course for the first time,
  • Having successfully completed the Internal Medicine Nursing course,
  • He voluntarily agreed to participate in the study.
  • Having internet access

Exclusion Criteria:

  • To have received training (in-service training, course, seminar, etc.) on stoma care,
  • Having graduated from a health vocational high school and having experience in stoma care,
  • Taking the HEMSEC-217 Emergency Nursing course for the second time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Serious game web aplication
Nursing students played the serious game for two weeks.
Behavioral: serious game based web application education
serious game based web application education for nursing students
No Intervention: Control grup

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To measure nursing student's information
Time Frame: 4 week
The data will be collected through introductory features form, 'Stoma Care Information Form', In the first stage of the study, the students will be given a 'Stoma Care Information Form' (first knowledge). 'Stoma Care Information Form' (second information) will be applied after completing the theoretical lesson of stoma care and group work in the laboratory of students in the experimental and control groups. There are 20 questions on the subject in the knowledge test and the lowest 0 and the highest 20 points are taken from the test. Increasing score indicates higher achievement.
4 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To measure nursing student's skill
Time Frame: 4 week
Unlike the control group, the mobile phones of students in the experimental group; A serious game-based virtual reality mobile application on stoma care prepared as a support for formal education will be installed. After the students play the application, skill measurements will be made in the laboratory with 'Skill Checklists'. Skill measurements of students will be made with an objective structured clinical exam.The skill checklist includes 36 process steps that students are expected to perform. 2 points were given for each correct step evaluated in the list, 1 point for the missing step, and 0 points for each unfulfilled step. A minimum of 0 and a maximum of 72 points can be obtained from the skill checklist. Increasing score indicates higher achievement.
4 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To determine permanence of the method
Time Frame: 4 week
The results obtained after the application will be analyzed and the impact of serious game based virtual reality mobile application on stoma care education will be determined. The scale consists of three sub-dimensions as system usefulness (items 1-6), quality of information (items 7-9), and interface quality (items 10-12), and item 13 measures overall satisfaction. Each item is scored as 1 (Strongly agree) - 7 (Strongly disagree). A low score from the scale indicates high usability.
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gümüşhane Universıty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GumushaneU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data will be available 01.06.2022 and 01.12.2020

IPD Sharing Access Criteria

Non

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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