Surgical StomaNCT05332535
Serious Game On Stoma Care Education For Nursing Students
A study testing serious game based web application education in people with Surgical Stoma and Nursing, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Stoma, Nursing, Video Games
- What is being tested?
- serious game based web application education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Surgical Stoma, Nursing, Video Games
- Being tested
- serious game based web application education
- Keywords
- Education, Nursing, Student, Surgical stoma, Video games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious game based web application educationBehavioural
serious game based web application education for nursing students
| Study group | Role | What they receive |
|---|---|---|
| Serious game web aplication | Experimental | Nursing students played the serious game for two weeks. Receives: Behavioral: serious game based web application education |
| Control grup | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure nursing student's information
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.
Measured: 4 week
Secondary outcomes (1)
To measure nursing student's skill
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.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start20 Oct 2021
- Primary completion12 Dec 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursen Kulakac, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332535
- Sponsor's protocol ID
- GumushaneU
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Serious Game-Based Web Application On Stoma Care Education For Nursing Students
- ClinicalTrials.gov ID
- NCT05332535
- Acronym / sponsor ID
- GumushaneU
- Conditions
- Surgical Stoma, Nursing, Video Games
- Keywords
- Education, Nursing, Student, Surgical stoma, Video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious game web aplication | Experimental | Behavioral: serious game based web application educationNursing students played the serious game for two weeks. |
| Control grup | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serious game based web application educationserious game based web application education for nursing students | Behavioural | Serious game web aplication |
Primary outcome
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.
1 secondary outcome
To measure nursing student's skill
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious game based web application education in people with Surgical Stoma and Nursing, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure nursing student's information (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.