SimulationNCT05040191
The Effect of Haptic Interactive Virtual Reality on Nasogastric Tube Practice Teaching
A study testing Haptic interactive virtual reality simulation training and Haptic interactive computer-based simulation training in people with Simulation and Nasogastric Tube, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
This research was carried out as a randomized controlled experimental study to evaluate the effects of haptic interactive virtual reality and computer-based simulation technologies on students' knowledge, skills, anxiety, satisfaction in learning and self-confidence in teaching nasogastric tube application. Read more about this study
- Who is it for?
- Ages 19 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation, Nasogastric Tube
- What is being tested?
- Haptic interactive virtual reality simulation training and Haptic interactive computer-based simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Jul 2021
- 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 19 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students;
- Over 18 years old,
- Registered in the nursing department,
- Able to use a computer,
- No vision and hearing problems
- Have not done the NGT skill practice before,
- Taking the Nursing Fundamentals course for the first time.
Who cannot join
- Students;
- Under 18 years old,
- Can't use a computer,
- Having vision and hearing problems,
- Have done NGT skill practice before,
- Having taken the Nursing Fundamentals course before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Haptic Interactive Virtual Reality and Computer-Based Simulation Technologies on Students' Achievement and Anxiety Levels in Nasogastric Tube Practice Teaching
This research was carried out as a randomized controlled experimental study to evaluate the effects of haptic interactive virtual reality and computer-based simulation technologies on students' knowledge, skills, anxiety, satisfaction in learning and self-confidence in teaching nasogastric tube application.
The research population consisted of students who enrolled in a foundation university nursing department and took the "Basic Principles and Practices in Nursing II" course in the Spring Semester of the 2020-2021 academic year, and the sample consisted of 90 students who met the inclusion criteria of the study. During nasogastric tube application, the Control Group (n=30) trained with the Standard Curriculum, Experimental Group 1 (n=30) trained with Haptic Interactive Virtual Reality Simulation Technology, and Experimental Group 2 (n=30) trained with Haptic Interactive Computer-Based Simulation. n=30) was performed. Research data were collected with "Structured Student Introduction Form", "Nasogastric Tube Application Skills Examination", "Nasogastric Tube Application Skill Checklist", "State-Trait Anxiety Inventory", "Student Satisfaction and Self-Confidence in Learning Scale". Appropriate statistical methods were used in the analysis of the data.
Read the detailed description
Traditional learning methods and environments are thought to be insufficient to respond to the differing expectations of generation z, who were born and raised in a digital age. For this reason, it has become mandatory for educational institutions to renew their curricula and support them with advanced technologies. All over the world, higher education programs are trying to expand their educational capacities by applying innovative strategies to meet the future workforce needs. Nursing educators also report that fundamental changes in existing curricula are necessary for innovation. Since nursing is a profession that requires the acquisition of cognitive, psychomotor and attitudinal behaviors, it is important to use innovative practices in education. While these applications increase the attention of the student, they save the education from monotony and ensure the permanence of the education by ensuring the active participation of the student. Due to the fact that today is the age of technology, the use and development of new learning tools has increased at every stage of the nursing education process. These developments in technology and education have brought together these two fields and the use of simulation applications used to increase technical and non-technical skills in nursing education has become widespread.
Nasogastric tube (NGT) application, which is one of the interventions that students should develop in nursing education, is an invasive intervention that is frequently applied for enteral nutrition, drug administration and gastric decompression and is the responsibility of health professionals.
Since the beginning of professional nursing education, different teaching methods have been applied to improve nasogastric tube application skills.
According to traditional teaching methods, in teaching NGT practice skill, educators explain the purpose, indications, complications, application method, necessary materials and nursing interventions that need attention in the classroom. Then, demonstration of NGT application skill on a model is made in order to transform theoretical knowledge into behavior in nursing skills laboratories. Due to the fact that it is an invasive procedure with various complications, NGT application by students in the clinical field is limited, so the development and reinforcement of the behavior is left after graduation. It is envisaged that in the teaching of NGT application skill with haptic interactive virtual reality simulation technology, students' knowledge, skills and self-confidence levels will increase, allowing them to feel like a nurse in the patient room that reflects the real hospital conditions, and they will develop and reinforce the NGT application skill, which is a complex initiative in a risk-free environment before graduation. Based on this information, the aim of this study is to reveal the effects of haptic interactive virtual reality and computer-based simulation technologies on students' knowledge, skills, anxiety, satisfaction in learning and self-confidence in teaching nasogastric tube application.
- Conditions
- Simulation, Nasogastric Tube
- Being tested
- Traditional Education(control), Haptic interactive virtual reality simulation training, Haptic interactive computer-based simulation training
- Keywords
- virtual reality, simulation, nasogastric tube, haptic glove
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Education(control)Other
The application was made on the model that allows nasogastric tube application and the anatomical structure in the nasogastric region is seen. The student can experience the skill of applying a nasogastric tube to the nasogastric or orgastric region on this model. In the nursing skills laboratory, students were given a demonstration of nasogastric tube application on a model.
Haptic interactive virtual reality simulation trainingOther
Haptic interactive virtual reality simulation technology; It functions by using haptic gloves that are interactive, visually enhanced, containing three-dimensional video and animation, wearable by students. This program has been developed by a software developer who is an expert in the field of information technologies, using the unreal program with a nine-generation computer with a game engine. All the necessary steps in the NGT application have been in simulation.
Haptic interactive computer-based simulation trainingOther
"Clinical tvr (tactile simulator)" produced by a foreign commercial company used in nursing education was used. Clinical tvr simulation applications can be accessed online or downloaded to a computer. This simulator; It functions by using an interactive, visually enhanced 2D, animated, haptic arm that can be held by students like a pen. It includes applications such as nasogastric tube placement, urinary bladder catheter placement, heart massage. These applications can be realized through both mouse and haptic arm computer input devices. clinical tvr; It is a simulator that incorporates the enhanced benefits of haptic feedback through the use of haptic technology. This simulator provides a near-realistic sensory experience where the learner can practice a skill as it actually is. Computer-based simulation with haptic interaction was used in this study with the haptic arm in NGT application skill.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Application in the Control Group: After the theoretical lesson, the control group was taken to the Nursing Fundamentals Skills Laboratory. The laboratory consists of 3 practice rooms, 1 control room and 1 analysis room. A video prepared by the researcher on the Simple Nasogastric Tube Application Model in line with the steps of "Checklist for Teaching Nasogastric Tube Application Skills" was watched and preliminary information was given. The questions were answered by allowing the students to ask questions. Receives: Other: Traditional Education(control) |
| Haptic Interactive Virtual Reality Simulation(Experiment 1 group) | Experimental | Application in the Experiment-1 Group: After the theoretical lesson, the students in the Experiment-1 group were taken to the computer laboratory room where the haptic interactive virtual reality application was installed. The Nasogastric Tube Application with Haptic Interactive Virtual Reality Simulation was applied and explained by the researcher and preliminary information was given. The questions were answered by allowing the students to ask questions. Receives: Other: Haptic interactive virtual reality simulation training |
| Haptic Interactive Computer Based Simulation(Experiment 2 group) | Experimental | Application in the Experiment-2 Group: After the theoretical lesson, the students in the Experiment-2 group were taken to the laboratory room where the haptic interactive computer-based simulation was located. This computer-assisted simulation allows us to see the application on the computer screen while performing an application with a haptic arm. It gives feedback on hand manipulations similar to reality. It was explained by the researcher by applying the nasogastric tube application skill with haptic interactive computer-based simulation and preliminary information was given. The questions were answered by allowing the students to ask questions. Receives: Other: Haptic interactive computer-based simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasogastric tube application skill success levels
Students were informed about the "Nasogastric Tube Application Skill Checklist"
Measured: 2 Months
Secondary outcomes (1)
Anxiety levels
Students were informed about the "State-Trait Anxiety Inventory"
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 May 2021
- Primary completion15 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SimulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamiyet KIZIL, University of Beykent
- Investigators
- Hamiyet Kızıl, RN Msc, Principal investigator, Beykent University Istanbul,Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040191
- Sponsor's protocol ID
- 1870
- Status last verified
- Sep 2021
- First submitted
- 17 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
SENDIR, M., & KIZIL, H. (2019). An innovative approach in teaching nasogastric tube application: NAZO-AR. Journal of Duzce University Institute of Health Sciences, 9(2), 86-90.
Choi KS, He XJ, Chiang VC, Deng Z, Qin J. A Heuristic Force Model for Haptic Simulation of Nasogastric Tube Insertion Using Fuzzy Logic. IEEE Trans Haptics. 2016 Jul-Sep;9(3):295-310. doi: 10.1109/TOH.2016.2550044. Epub 2016 Apr 6.
PubMed 27071195
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Haptic Interactive Virtual Reality and Computer-Based Simulation Technologies on Students' Achievement and Anxiety Levels in Nasogastric Tube Practice Teaching
- ClinicalTrials.gov ID
- NCT05040191
- Acronym / sponsor ID
- 1870
- Conditions
- Simulation, Nasogastric Tube
- Keywords
- virtual reality, simulation, nasogastric tube, haptic glove
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 10 Sep 2021 (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.
This research was carried out as a randomized controlled experimental study to evaluate the effects of haptic interactive virtual reality and computer-based simulation technologies on students' knowledge, skills, anxiety, satisfaction in learning and self-confidence in teaching nasogastric tube application.
The research population consisted of students who enrolled in a foundation university nursing department and took the "Basic Principles and Practices in Nursing II" course in the Spring Semester of the 2020-2021 academic year, and the sample consisted of 90 students who met the inclusion criteria of the study. During nasogastric tube application, the Control Group (n=30) trained with the Standard Curriculum, Experimental Group 1 (n=30) trained with Haptic Interactive Virtual Reality Simulation Technology, and Experimental Group 2 (n=30) trained with Haptic Interactive Computer-Based Simulation. n=30) was performed. Research data were collected with "Structured Student Introduction Form", "Nasogastric Tube Application Skills Examination", "Nasogastric Tube Application Skill Checklist", "State-Trait Anxiety Inventory", "Student Satisfaction and Self-Confidence in Learning Scale". Appropriate statistical methods were used in the analysis of the data.
Detailed description
Traditional learning methods and environments are thought to be insufficient to respond to the differing expectations of generation z, who were born and raised in a digital age. For this reason, it has become mandatory for educational institutions to renew their curricula and support them with advanced technologies. All over the world, higher education programs are trying to expand their educational capacities by applying innovative strategies to meet the future workforce needs. Nursing educators also report that fundamental changes in existing curricula are necessary for innovation. Since nursing is a profession that requires the acquisition of cognitive, psychomotor and attitudinal behaviors, it is important to use innovative practices in education. While these applications increase the attention of the student, they save the education from monotony and ensure the permanence of the education by ensuring the active participation of the student. Due to the fact that today is the age of technology, the use and development of new learning tools has increased at every stage of the nursing education process. These developments in technology and education have brought together these two fields and the use of simulation applications used to increase technical and non-technical skills in nursing education has become widespread.
Nasogastric tube (NGT) application, which is one of the interventions that students should develop in nursing education, is an invasive intervention that is frequently applied for enteral nutrition, drug administration and gastric decompression and is the responsibility of health professionals.
Since the beginning of professional nursing education, different teaching methods have been applied to improve nasogastric tube application skills.
According to traditional teaching methods, in teaching NGT practice skill, educators explain the purpose, indications, complications, application method, necessary materials and nursing interventions that need attention in the classroom. Then, demonstration of NGT application skill on a model is made in order to transform theoretical knowledge into behavior in nursing skills laboratories. Due to the fact that it is an invasive procedure with various complications, NGT application by students in the clinical field is limited, so the development and reinforcement of the behavior is left after graduation. It is envisaged that in the teaching of NGT application skill with haptic interactive virtual reality simulation technology, students' knowledge, skills and self-confidence levels will increase, allowing them to feel like a nurse in the patient room that reflects the real hospital conditions, and they will develop and reinforce the NGT application skill, which is a complex initiative in a risk-free environment before graduation. Based on this information, the aim of this study is to reveal the effects of haptic interactive virtual reality and computer-based simulation technologies on students' knowledge, skills, anxiety, satisfaction in learning and self-confidence in teaching nasogastric tube application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Traditional Education(control)Application in the Control Group: After the theoretical lesson, the control group was taken to the Nursing Fundamentals Skills Laboratory. The laboratory consists of 3 practice rooms, 1 control room and 1 analysis room. A video prepared by the researcher on the Simple Nasogastric Tube Application Model in line with the steps of "Checklist for Teaching Nasogastric Tube Application Skills" was watched and preliminary information was given. The questions were answered by allowing the students to ask questions. |
| Haptic Interactive Virtual Reality Simulation(Experiment 1 group) | Experimental | Other: Haptic interactive virtual reality simulation trainingApplication in the Experiment-1 Group: After the theoretical lesson, the students in the Experiment-1 group were taken to the computer laboratory room where the haptic interactive virtual reality application was installed. The Nasogastric Tube Application with Haptic Interactive Virtual Reality Simulation was applied and explained by the researcher and preliminary information was given. The questions were answered by allowing the students to ask questions. |
| Haptic Interactive Computer Based Simulation(Experiment 2 group) | Experimental | Other: Haptic interactive computer-based simulation trainingApplication in the Experiment-2 Group: After the theoretical lesson, the students in the Experiment-2 group were taken to the laboratory room where the haptic interactive computer-based simulation was located. This computer-assisted simulation allows us to see the application on the computer screen while performing an application with a haptic arm. It gives feedback on hand manipulations similar to reality. It was explained by the researcher by applying the nasogastric tube application skill with haptic interactive computer-based simulation and preliminary information was given. The questions were answered by allowing the students to ask questions. |
Who may qualify
- Ages
- 19 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Students;
- Over 18 years old,
- Registered in the nursing department,
- Able to use a computer,
- No vision and hearing problems
Key exclusion criteria (6 listed)
- Students;
- Under 18 years old,
- Can't use a computer,
- Having vision and hearing problems,
- Have done NGT skill practice before,
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 |
|---|---|---|
| Traditional Education(control)The application was made on the model that allows nasogastric tube application and the anatomical structure in the nasogastric region is seen. The student can experience the skill of applying a nasogastric tube to the nasogastric or orgastric region on this model. In the nursing skills laboratory, students were given a demonstration of nasogastric tube application on a model. | Other | Control Group |
| Haptic interactive virtual reality simulation trainingHaptic interactive virtual reality simulation technology; It functions by using haptic gloves that are interactive, visually enhanced, containing three-dimensional video and animation, wearable by students. This program has been developed by a software developer who is an expert in the field of information technologies, using the unreal program with a nine-generation computer with a game engine. All the necessary steps in the NGT application have been in simulation. | Other | Haptic Interactive Virtual Reality Simulation(Experiment 1 group) |
| Haptic interactive computer-based simulation training"Clinical tvr (tactile simulator)" produced by a foreign commercial company used in nursing education was used. Clinical tvr simulation applications can be accessed online or downloaded to a computer. This simulator; It functions by using an interactive, visually enhanced 2D, animated, haptic arm that can be held by students like a pen. It includes applications such as nasogastric tube placement, urinary bladder catheter placement, heart massage. These applications can be realized through both mouse and haptic arm computer input devices. clinical tvr; It is a simulator that incorporates the enhanced benefits of haptic feedback through the use of haptic technology. This simulator provides a near-realistic sensory experience where the learner can practice a skill as it actually is. Computer-based simulation with haptic interaction was used in this study with the haptic arm in NGT application skill. | Other | Haptic Interactive Computer Based Simulation(Experiment 2 group) |
Primary outcome
nasogastric tube application skill success levels
Time frame: 2 Months
Students were informed about the "Nasogastric Tube Application Skill Checklist"
1 secondary outcome
Anxiety levels
Time frame: 2 Months
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 10 Sep 2021.
- BackgroundSENDIR, M., & KIZIL, H. (2019). An innovative approach in teaching nasogastric tube application: NAZO-AR. Journal of Duzce University Institute of Health Sciences, 9(2), 86-90.
- Results publication: PubMed 27071195Choi KS, He XJ, Chiang VC, Deng Z, Qin J. A Heuristic Force Model for Haptic Simulation of Nasogastric Tube Insertion Using Fuzzy Logic. IEEE Trans Haptics. 2016 Jul-Sep;9(3):295-310. doi: 10.1109/TOH.2016.2550044. Epub 2016 Apr 6.
- 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.
Hamiyet Kızıl, RN Msc principal investigator
Beykent University Istanbul,Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haptic interactive virtual reality simulation training and Haptic interactive computer-based simulation training in people with Simulation and Nasogastric Tube, run by University of Beykent 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 7 inclusion and 6 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 10 Sep 2021. 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?
nasogastric tube application skill success levels (time frame: 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040191, which also lists 2 linked publications.
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 10 Sep 2021.