Virtual RealityNCT06114446
The Evaluation of the Effectiveness of Nursing Care Education Provided With Immersive Virtual Reality
A study testing simulation group, immersive virtual reality and observation in people with Virtual Reality and Nursing Care, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Nursing education is composed of both theoretical and practical training that complement each other. The clinical practice environment for students is quite complex and practical applications are highly variable. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Nursing Care, Colorectal Surgery
- What is being tested?
- simulation group, immersive virtual reality and observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2024to 1 Jul 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 be a second-grade student
- to be taking the Surgical Diseases Nursing course,
Who cannot join
- to have taken the course before
- to repeat the course
- enter the semester through vertical or horizontal transfer programs
- graduate of a vocational high school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Effectiveness of Colorectal Surgery Nursing Care Education Given to Nursing Students Via an Immersive Virtual Reality Environment
Nursing education is composed of both theoretical and practical training that complement each other. The clinical practice environment for students is quite complex and practical applications are highly variable. Practical application areas do not offer effective and equal opportunities to meet the learning and application goals. There are also problems in theoretical education, and current teaching techniques cannot adequately support students' learning. In nursing education, it is recommended to use different teaching methods that strengthen students' skills. One of these methods is virtual reality simulation, which simulates real-life procedures.
The investigators's aim in this project is to reveal the effect of the use of immersive virtual reality on the effectiveness of education in surgical nursing education through nursing care offered for a specific surgical procedure. With the laboratory setup, software tool(s), and the self-sufficient employees being able to use the software, via the capabilities gained through this project, it will be possible to carry out various types of virtual reality training activities by different departments of investigator's university without the need for out-sourcing. The investigators's advanced goal in this project is to transfer the nursing care specific to frequently applied surgical interventions to the immersive virtual reality environment.
Read the detailed description
This study uses the randomized controlled experiment method with pretest-posttest. The population of the study is the students taking surgical disease care courses (100-110 students per year). The required sample size was calculated by reviewing similar studies in the literature and using the G * Power 3.1 program. It was decided that the sample would consist of 35 experimental and 35 control groups. The data collection forms (knowledge level, observed skills, and self-evaluation of clinical skill competence) were developed by the researchers based on the literature.
In this study, there are 2 groups, experimental and control groups, and at the end of the study, investigators will observe all group members individually.
At the beginning of the study, data collection forms will be completed in all groups. All participants will be asked to perform ostomy care on standardized patients. During this time, students' nursing skills will be observed individually.
Colorectal surgery nursing care will be performed in an immersive virtual reality environment in the experimental group and on a practice manikin in the nursing skills laboratory in the control group. Participants in both the control and the virtual reality groups will be included in the debriefing. After the implementation participants will complete the data collection forms again. All participants will be asked to perform ostomy care on standardized patients. During this time, students' nursing skills will be observed individually.
The quantitative data to be obtained will be analyzed using Statistical Package for Social Science (SPSS).
The simulation scenario, which will be transferred to an immersive virtual environment, includes early and late postoperative care of a patient who underwent colorectal surgery.
The research will begin in the second semester of the 2023-2024 academic year in the surgical nursing course after the completion of the data collection tools and will be completed in one academic year.
- Conditions
- Virtual Reality, Nursing Care, Colorectal Surgery, Nursing Student, Education
- Being tested
- simulation group, immersive virtual reality, observation
- Keywords
- colorectal surgery, education technologies, nursing education, immersive virtual reality, nursing students, nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation groupOther
Participants will be educated with simulation manikin for postoperative nursing care of a patient who underwent colorectal surgery
immersive virtual realityOther
Participants will be educated with immersive virtual simulation f for postoperative nursing care of a patient who underwent colorectal surgery
observationOther
All participants who participate in simulation or immersive virtual arms will be observed to assess postoperative nursing care skills
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will be educated with immersive virtual reality simulation for postoperative nursing care of a patient who underwent colorectal surgery Receives: Other: immersive virtual reality; Other: observation |
| Control group | Other | Participants will be educated with simulation manikin for postoperative nursing care of a patient who underwent colorectal surgery Receives: Other: simulation group; Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Surgery Nursing Care Knowledge Assessment Form
Investigators will use a form to measure participants' knowledge level related to colorectal surgery care. The form includes 20 questions and will be used it several times (before the implementation, two times after the implementation). Evaluation will be made out of 100 points. Higher scores will mean a better outcome.
Measured: one day
Ostomy Care Skills Observation Form
Investigators will use a checklist to determine the participants's nursing care skills. Investigators will observe all participants during nursing care with standardized patient. The checklist includes 20 nursing care skills related to ostomy care and will be used before and after the implementation. Evaluation will be made out of 100 points. Higher scores will mean a better outcome.
Measured: one day
Participant's Clinical Skill Competence Self Evaluation Form
This form will be used for participants's self-evaluation of skill competence. This form consists of 20 nursing care skills related to postoperative colorectal surgery patient care. It will be used before and after the implementation. Evaluation will be made out of 100 points. Higher scores will mean a better outcome.
Measured: one day
Secondary outcomes (1)
Participants' experiences of immersive virtual reality
This form will be used for getting participants' virtual reality experiences and opinions.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start6 Mar 2024
- Primary completion5 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Elif Akyüz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114446
- Sponsor's protocol ID
- EAkyuz
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2023
- Last updated
- 9 Oct 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effectiveness of Colorectal Surgery Nursing Care Education Given to Nursing Students Via an Immersive Virtual Reality Environment
- ClinicalTrials.gov ID
- NCT06114446
- Acronym / sponsor ID
- EAkyuz
- Conditions
- Virtual Reality, Nursing Care, Colorectal Surgery, Nursing Student, Education
- Keywords
- colorectal surgery, education technologies, nursing education, immersive virtual reality, nursing students, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 2 Nov 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.
Nursing education is composed of both theoretical and practical training that complement each other. The clinical practice environment for students is quite complex and practical applications are highly variable. Practical application areas do not offer effective and equal opportunities to meet the learning and application goals. There are also problems in theoretical education, and current teaching techniques cannot adequately support students' learning. In nursing education, it is recommended to use different teaching methods that strengthen students' skills. One of these methods is virtual reality simulation, which simulates real-life procedures.
The investigators's aim in this project is to reveal the effect of the use of immersive virtual reality on the effectiveness of education in surgical nursing education through nursing care offered for a specific surgical procedure. With the laboratory setup, software tool(s), and the self-sufficient employees being able to use the software, via the capabilities gained through this project, it will be possible to carry out various types of virtual reality training activities by different departments of investigator's university without the need for out-sourcing. The investigators's advanced goal in this project is to transfer the nursing care specific to frequently applied surgical interventions to the immersive virtual reality environment.
Detailed description
This study uses the randomized controlled experiment method with pretest-posttest. The population of the study is the students taking surgical disease care courses (100-110 students per year). The required sample size was calculated by reviewing similar studies in the literature and using the G * Power 3.1 program. It was decided that the sample would consist of 35 experimental and 35 control groups. The data collection forms (knowledge level, observed skills, and self-evaluation of clinical skill competence) were developed by the researchers based on the literature.
In this study, there are 2 groups, experimental and control groups, and at the end of the study, investigators will observe all group members individually.
At the beginning of the study, data collection forms will be completed in all groups. All participants will be asked to perform ostomy care on standardized patients. During this time, students' nursing skills will be observed individually.
Colorectal surgery nursing care will be performed in an immersive virtual reality environment in the experimental group and on a practice manikin in the nursing skills laboratory in the control group. Participants in both the control and the virtual reality groups will be included in the debriefing. After the implementation participants will complete the data collection forms again. All participants will be asked to perform ostomy care on standardized patients. During this time, students' nursing skills will be observed individually.
The quantitative data to be obtained will be analyzed using Statistical Package for Social Science (SPSS).
The simulation scenario, which will be transferred to an immersive virtual environment, includes early and late postoperative care of a patient who underwent colorectal surgery.
The research will begin in the second semester of the 2023-2024 academic year in the surgical nursing course after the completion of the data collection tools and will be completed in one academic year.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: immersive virtual reality, Other: observationParticipants will be educated with immersive virtual reality simulation for postoperative nursing care of a patient who underwent colorectal surgery |
| Control group | Other | Other: simulation group, Other: observationParticipants will be educated with simulation manikin for postoperative nursing care of a patient who underwent colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to be a second-grade student
- to be taking the Surgical Diseases Nursing course,
Key exclusion criteria (4 listed)
- to have taken the course before
- to repeat the course
- enter the semester through vertical or horizontal transfer programs
- graduate of a vocational high school
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 |
|---|---|---|
| simulation groupParticipants will be educated with simulation manikin for postoperative nursing care of a patient who underwent colorectal surgery | Other | Control group |
| immersive virtual realityParticipants will be educated with immersive virtual simulation f for postoperative nursing care of a patient who underwent colorectal surgery | Other | Experimental group |
| observationAll participants who participate in simulation or immersive virtual arms will be observed to assess postoperative nursing care skills | Other | Control group, Experimental group |
Primary outcome
Colorectal Surgery Nursing Care Knowledge Assessment Form
Time frame: one day
Investigators will use a form to measure participants' knowledge level related to colorectal surgery care. The form includes 20 questions and will be used it several times (before the implementation, two times after the implementation). Evaluation will be made out of 100 points. Higher scores will mean a better outcome.
Ostomy Care Skills Observation Form
Time frame: one day
Investigators will use a checklist to determine the participants's nursing care skills. Investigators will observe all participants during nursing care with standardized patient. The checklist includes 20 nursing care skills related to ostomy care and will be used before and after the implementation. Evaluation will be made out of 100 points. Higher scores will mean a better outcome.
Participant's Clinical Skill Competence Self Evaluation Form
Time frame: one day
This form will be used for participants's self-evaluation of skill competence. This form consists of 20 nursing care skills related to postoperative colorectal surgery patient care. It will be used before and after the implementation. Evaluation will be made out of 100 points. Higher scores will mean a better outcome.
1 secondary outcome
Participants' experiences of immersive virtual reality
Time frame: one 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 9 Oct 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 simulation group, immersive virtual reality and observation in people with Virtual Reality and Nursing Care, run by Kırıkkale 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 2 inclusion and 4 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 9 Oct 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?
Colorectal Surgery Nursing Care Knowledge Assessment Form (time frame: one day). The study lists 3 primary outcomes in all. 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 9 Oct 2024.