HealthyNCT05720520
Effect of Game-Based Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Care
A study testing Technological education method in people with Healthy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The purpose is to determine effect of game-based virtual reality phone application on nursing students' knowledge and skills on intestinal stoma and peristomal skin care. Material and methods:This study will be conducted as a single-blind randomized controlled experimental study between March-April 2023. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Technological education method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2023to 29 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To register for the Nursing Fundamentals Course for the first time,
- Participating in theoretical lessons and group work,
- Participating in knowledge and skill assessments on stoma and peristomal skin care,
- Having an Android phone,
- Having internet access,
- Volunteer to participate in the research.
Who cannot join
- Have any previous training in stoma and peristomal skin care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Game-Based Virtual Reality Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Skin Care
Purpose: The purpose is to determine effect of game-based virtual reality phone application on nursing students' knowledge and skills on intestinal stoma and peristomal skin care.
Material and methods:This study will be conducted as a single-blind randomized controlled experimental study between March-April 2023. The students in the experimental group will play the developed mobile game on stoma and peristomal skin care as much as they want for 5 days, while the students in the control group will perform skills on stoma and peristomal skin care on the model in the skill laboratory for only one day. After performing the inteventions, the skills and knowledge measurements of the students in both groups will be measured by the researcher through the forms prepared in accordance with the literature. After four weeks, the permanence levels of the students in both groups regarding stoma and peristomal skin care will be measured and the data collection process of the study will be terminated.
- Conditions
- Healthy
- Being tested
- Technological education method
- Keywords
- Nursing Education, Nursing Student, Phone Application, Stoma Care, Peristomal Skin Care, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological education methodOther
Students in the experimental group will play the mobile application developed for stoma and peristomal skin care and are expected to learn the skill in this way. The students in the control group, on the other hand, will learn stoma and peristomal skin care on a model in the traditional skill laboratory and are expected to learn the skill in this way. Afterwards, the knowledge and skill scores of the two groups will be compared and the results will be reported.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Group | Experimental | Participants will use mobile application Receives: Other: Technological education method |
| Control Group | No intervention | Participants only will take traditional education method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma and Peristomal Skin Care Skill Form
"Stoma and Peristomal Skin Care Skill Checklist" was prepared by the researcher in accordance with the literature. For the suitability of the skill checklist and scoring, the opinion of an expert in the field of Assessment and Evaluation, 10 faculty members who are experts in the field of Nursing Fundamentals in terms of content validity, and two specialist nurses working in the stoma and wound care unit were obtained by Davis Technique. The opinions of the experts were analyzed with the Lawshe technique and the Content Validity Index (CGI) of the form was found to be 0.98. Then, necessary arrangements were made in line with the recommendations of the experts.
The checklist was classified as "Failed to perform" (0 points), "Partly performed" (1 point) and "Performed correctly" (2 points). "Stoma and Peristomal Skin Care Skill Checklist" consists of 27 steps and the lowest score that can be obtained from the scale is 0 and the highest score is 54. Higher scores indicate better results
Measured: 1 day
Secondary outcomes (1)
Stoma and Peristomal Skin Care Knowledge Form
The knowledge test was prepared by the researcher in accordance with the literature. The knowledge test is a test that questions students' knowledge of stoma and peristomal skin care. This test consists of 20 questions with five options. Each correct answer corresponds to 5 points. The lowest score 0 and the highest score 100 can be obtained from this test. Higher scores indicate better results. For the assurance of giving and obtaining information, an expert in the field of Assessment and Evaluation was obtained with the Davis technique, with 10 experts in the field of Nursing fundamentals in terms of the scope and validity of the scope. The opinions of the experts were analyzed with the Lawshe technique and the Scope Agreement Index (CGI) of the form was found to be 0.92. Necessary measures have been taken to ensure the training of trainers.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start20 Nov 2023
- Primary completion25 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Çalışkan, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720520
- Sponsor's protocol ID
- AIBU-SBF-MAC-02
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Game-Based Virtual Reality Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Skin Care
- ClinicalTrials.gov ID
- NCT05720520
- Acronym / sponsor ID
- AIBU-SBF-MAC-02
- Conditions
- Healthy
- Keywords
- Nursing Education, Nursing Student, Phone Application, Stoma Care, Peristomal Skin Care, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 9 Feb 2023 (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.
Purpose: The purpose is to determine effect of game-based virtual reality phone application on nursing students' knowledge and skills on intestinal stoma and peristomal skin care.
Material and methods:This study will be conducted as a single-blind randomized controlled experimental study between March-April 2023. The students in the experimental group will play the developed mobile game on stoma and peristomal skin care as much as they want for 5 days, while the students in the control group will perform skills on stoma and peristomal skin care on the model in the skill laboratory for only one day. After performing the inteventions, the skills and knowledge measurements of the students in both groups will be measured by the researcher through the forms prepared in accordance with the literature. After four weeks, the permanence levels of the students in both groups regarding stoma and peristomal skin care will be measured and the data collection process of the study will be terminated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Group | Experimental | Other: Technological education methodParticipants will use mobile application |
| Control Group | No intervention | –Participants only will take traditional education method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To register for the Nursing Fundamentals Course for the first time,
- Participating in theoretical lessons and group work,
- Participating in knowledge and skill assessments on stoma and peristomal skin care,
- Having an Android phone,
- Having internet access,
Key exclusion criteria (1 listed)
- Have any previous training in stoma and peristomal skin care
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 |
|---|---|---|
| Technological education methodStudents in the experimental group will play the mobile application developed for stoma and peristomal skin care and are expected to learn the skill in this way. The students in the control group, on the other hand, will learn stoma and peristomal skin care on a model in the traditional skill laboratory and are expected to learn the skill in this way. Afterwards, the knowledge and skill scores of the two groups will be compared and the results will be reported. | Other | Mobile Application Group |
Primary outcome
Stoma and Peristomal Skin Care Skill Form
Time frame: 1 day
"Stoma and Peristomal Skin Care Skill Checklist" was prepared by the researcher in accordance with the literature. For the suitability of the skill checklist and scoring, the opinion of an expert in the field of Assessment and Evaluation, 10 faculty members who are experts in the field of Nursing Fundamentals in terms of content validity, and two specialist nurses working in the stoma and wound care unit were obtained by Davis Technique. The opinions of the experts were analyzed with the Lawshe technique and the Content Validity Index (CGI) of the form was found to be 0.98. Then, necessary arrangements were made in line with the recommendations of the experts. The checklist was classified as "Failed to perform" (0 points), "Partly performed" (1 point) and "Performed correctly" (2 points). "Stoma and Peristomal Skin Care Skill Checklist" consists of 27 steps and the lowest score that can be obtained from the scale is 0 and the highest score is 54. Higher scores indicate better results
1 secondary outcome
Stoma and Peristomal Skin Care Knowledge Form
Time frame: 1 day
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 15 Nov 2024.
- Individual participant dataSharing planned: No
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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 Technological education method in people with Healthy, run by Abant Izzet Baysal University 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 6 inclusion and 1 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 15 Nov 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?
Stoma and Peristomal Skin Care Skill Form (time frame: 1 day). 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 15 Nov 2024.