The Effect of Serious Games

January 24, 2023 updated by: Cemile AKTUG, Gümüşhane Universıty

The Effect of Serious Game-Based and Video-Assisted Practices in Sterile Dressing and Surgical Instrument Preparation Education on Nursing Students' Knowledge, Skills and Anxiety Levels

Today, there is a need to integrate and restructure rapidly developing technology into teaching environments. When web-based applications, which are among the popular and innovative technologies, are examined, it is seen that they are used in many areas of education. In this study, it was aimed to evaluate the effects of sterile hand washing, sterile dressing, sterile package opening and surgical instrument preparation training on anxiety, satisfaction, knowledge and skill levels by designing a serious game-based web application that allows nursing students to gain skills and practice in psychomotor applications. The universe of the study will consist of students enrolled in the Operating Room Nursing course in the Nursing Department of the Faculty of Health Sciences of Gümüşhane University in the spring semester of the 2021-2022 academic year, and the sample will consist of 94 students who meet the study criteria and agree to participate in the study. Data; It will be collected with the Introductory Characteristics Form, Operating Room Applications Information Form, Sterile Dressing and Surgical Instrument Preparation Skills Checklist, State Trait Anxiety Scale (WHO) and Visual Comparison Scale (GLO). Oral lectures will be given to all students by the instructor in charge of the course for two hours a week for two weeks, according to the lesson plan. Before the oral presentation, the 'Student Information Form' and the 'Operating Room Applications Information Form' will be applied to the students. After the questionnaire applications, the students will be divided into two groups, 47 students in the intervention group and 47 students in the control group, by randomization method. A serious game-based web application will be downloaded to the mobile phones of the students in the intervention group, on sterile dressing and surgical instrument preparation training, prepared in accordance with the formal education curriculum. How to use it will be shown. The students in the control group will be shown the video prepared by the researcher on sterile dressing and surgical instrument preparation training. Students in both groups will be informed that they can use this application for two weeks whenever they want and as much as they want. At the end of two weeks, a skill test will be given to the control and intervention groups in the laboratory. WHO will be applied to both groups before and after the skill test. Immediately after the skill test, the Operating Room Applications Information Form will be applied to both groups to measure the level of knowledge, the State Anxiety Inventory (DBS) to determine their anxiety level, and the GAS to measure satisfaction. Three weeks after the first skill test, students' second skill measures will be evaluated using the 'Surgical Instrument Preparation Skill Checklist', and their anxiety levels will be evaluated with the Trait Anxiety Inventory. The obtained data will be analyzed with appropriate statistical methods using the SPSS for Windows 23.0 program (Statistical Package for the Social Sciences)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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 (Anticipated)

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.
100

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Registering for the first time HEMSEC218 Operating Room Nursing course,
  • Having internet access,
  • Volunteering to participate in the study,
  • Smart phone, computer or tablet etc. that can activate the game. have one of the tools

Exclusion Criteria:

  • To have received training (in-service training, courses, seminars, etc.) related to operating room nursing,
  • Having graduated from a health vocational high school and having experience in the operating room,
  • Taking the HEMSEC218 Operating Room 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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
A serious game-based web application on Sterile Dressing and Surgical Instrument Preparation Training, which was prepared in accordance with the formal education curriculum and prepared as a support for formal education, will be downloaded to the mobile phones of the students in the intervention group.
Behavioral: Serious game
According to the curriculum, as of the third week, a serious game-based web application on Sterile Dressing and Surgical Instrument Preparation Training, which is prepared in accordance with the formal education curriculum and prepared as a support for formal education, will be downloaded to the mobile phones of the students in the intervention group as of the third week. Students would be informed that they could use the application for two weeks whenever they wanted and as much as they wanted.
Active Comparator: Video
The video prepared on sterile dressing and surgical instrument preparation training will be shown to the students in the control group for 2 weeks.
Behavioral: Serious game
According to the curriculum, as of the third week, a serious game-based web application on Sterile Dressing and Surgical Instrument Preparation Training, which is prepared in accordance with the formal education curriculum and prepared as a support for formal education, will be downloaded to the mobile phones of the students in the intervention group as of the third week. Students would be informed that they could use the application for two weeks whenever they wanted and as much as they wanted.

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
Outcome 1
Time Frame: 12 months
Sterile Dressing and Surgical Instrument Preparation at knowledge level
12 months

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
Outcome 2
Time Frame: 12 months
Sterile Dressing and Surgical Instrument Preparation skill level
12 months

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 (Anticipated)

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.
May 1, 2023

Primary Completion (Anticipated)

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.
July 1, 2023

Study Completion (Anticipated)

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 1, 2023

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).
July 21, 2022

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.
July 27, 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.
July 29, 2022

Study Record Updates

Last Update Posted (Estimate)

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 26, 2023

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 24, 2023

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, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • E-95674917-108.99-92819

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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