Educational ProblemsNCT04653233
Effectiveness of Haptic Technology in Teaching Urinary Catheterization Skill
A study testing 3D Systems Touch Haptic Simulator in people with Educational Problems, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Background: Haptic systems represent the highest level of computer based education technologies and enable students to learn at the highest level. These applications increase the student's focus as well as making the education non-monotonous and insuring teaching permanent by ensuring the active participation of the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- 3D Systems Touch Haptic Simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 30 Mar 2019
- 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
- being 18 years and over,
- enrolling for the first time in Fundamentals of Nursing course,
- participating in the study completely
- volunteering to participate
Who cannot join
- being a graduate of Health Vocational High School
Trial locations and contacts
1 site in 1 country.
About this study
Official title: University of Health Sciences, Hamidiye Nursing Faculty, Istanbul, Turkey
Background: Haptic systems represent the highest level of computer based education technologies and enable students to learn at the highest level. These applications increase the student's focus as well as making the education non-monotonous and insuring teaching permanent by ensuring the active participation of the student.
Objective: The study was conducted to determine the effectiveness of using haptic technology in teaching urinary catheter application skill on the level of success and satisfaction about this skill.
Read the detailed description
Method: This randomized-controlled experimental study was conducted with nursing students registered at a public university between December 2018 and March 2019. The sample of the study included 78 second grade students who gave consent after being informed about the aim of the study and who met the inclusion criteria. Control (n=39) and experimental (n=39) groups were determined through randomization using simple numbers table. Urinary catheterization application skill was taught with the standard curriculum (demonstration on the model) to the control group while it was taught with haptic-controlled computer based simulation technology to the experimental group. Data were collected using "Structured Student Introduction Form," "Skill Checklist for Teaching Urinary Catheterization Skill" and "Questionnaire for Satisfaction with Training Methods."
- Conditions
- Educational Problems
- Being tested
- 3D Systems Touch Haptic Simulator
- Keywords
- Haptic education technology, Computer based simulation, Nursing education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Systems Touch Haptic SimulatorDevice
This simulator is computer-aided and allows us to see this application on the computer screen while practicing with a haptic arm. It gives real-like feedback in hand manipulations. The simulator has a choice of 45 minutes of full instruction, 5 minutes of haptic arm only, or the option.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | After the theoretical lesson, the students in the experimental group were taken to the laboratory room where the 3D Systems Touch Haptic Simulator is located. The simulator has a choice of 45 minutes of full instruction, 5 minutes of haptic arm only, or the option. Since the preparation of the material in the full teaching method in the simulator takes a long time, these steps were removed to show similarity with the control group. The skill practice option for an average of 5-10 minutes where all steps of the Checklist for Teaching Urinary Catheterization Skill can be applied was used. Urinary catheterization with 3D Systems Touch Haptic Simulator was explained by 1 researcher who was responsible for the Fundamentals of Nursing course. Receives: Device: 3D Systems Touch Haptic Simulator |
| Control | No intervention | After the theoretical lesson, the control group was taken to Fundamentals of Nursing Skill Laboratory. 1 researcher, who is responsible for the Fundamentals of Nursing, was explained on the Simple Urinary Catheterization Model by applying the steps of "Checklist for Teaching Urinary Catheterization Skills". The students were allowed to ask questions and the questions asked were answered. Then all the students in the control group were taken to an empty class. The two researchers prepared the necessary materials for the urinary catheterization skill practice in the same way in separate rooms. The doors were closed to keep the environment calm during the application. One student was taken to each laboratory rooms in order not to be affected by each other. While the student was practicing, both researchers filled in the Checklist for Teaching Urinary Catheterization Skills. Satisfaction Questionnaire was given to the student who completed the application and asked to fill it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Catheterization Skill Score
The 25-item checklist prepared by the researchers based on the literature includes the application steps of urinary catheterization skill
Measured: through study completion, an average of 4 year
Satisfaction Questionnaire
The survey consists of 16 statements and the participants were asked to give a score for each instruction method on a five-item Likert-type scale between 1 and 5 (1-absolutely not agree, 5-absolutely agree). It is found that as the scale score average increases, students' satisfaction with the educational method increases, and as the scale score average decreases, their satisfaction with the education method decreases. In the evaluation of the scale, students are given a minimum of 16 and a maximum of 80 points for their satisfaction with their educational methods.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Dec 2018
- Primary completion1 Mar 2019
- Study completion30 Mar 2019
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 Educational ProblemsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed in a randomized controlled experimental type.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet İnangil, PhD, Istanbul Saglik Bilimleri University
- Investigators
- Demet İnangil, Dr, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653233
- Sponsor's protocol ID
- 1898
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozturk D, Dinc L. Effect of web-based education on nursing students' urinary catheterization knowledge and skills. Nurse Educ Today. 2014 May;34(5):802-8. doi: 10.1016/j.nedt.2013.08.007. Epub 2013 Aug 20.
PubMed 24011752Jung EY, Park DK, Lee YH, Jo HS, Lim YS, Park RW. Evaluation of practical exercises using an intravenous simulator incorporating virtual reality and haptics device technologies. Nurse Educ Today. 2012 May;32(4):458-63. doi: 10.1016/j.nedt.2011.05.012. Epub 2011 Jun 12.
PubMed 21664014
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Health Sciences, Hamidiye Nursing Faculty, Istanbul, Turkey
- ClinicalTrials.gov ID
- NCT04653233
- Acronym / sponsor ID
- 1898
- Conditions
- Educational Problems
- Keywords
- Haptic education technology, Computer based simulation, Nursing education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 4 Dec 2020 (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.
Background: Haptic systems represent the highest level of computer based education technologies and enable students to learn at the highest level. These applications increase the student's focus as well as making the education non-monotonous and insuring teaching permanent by ensuring the active participation of the student.
Objective: The study was conducted to determine the effectiveness of using haptic technology in teaching urinary catheter application skill on the level of success and satisfaction about this skill.
Detailed description
Method: This randomized-controlled experimental study was conducted with nursing students registered at a public university between December 2018 and March 2019. The sample of the study included 78 second grade students who gave consent after being informed about the aim of the study and who met the inclusion criteria. Control (n=39) and experimental (n=39) groups were determined through randomization using simple numbers table. Urinary catheterization application skill was taught with the standard curriculum (demonstration on the model) to the control group while it was taught with haptic-controlled computer based simulation technology to the experimental group. Data were collected using "Structured Student Introduction Form," "Skill Checklist for Teaching Urinary Catheterization Skill" and "Questionnaire for Satisfaction with Training Methods."
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is designed in a randomized controlled experimental type.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: 3D Systems Touch Haptic SimulatorAfter the theoretical lesson, the students in the experimental group were taken to the laboratory room where the 3D Systems Touch Haptic Simulator is located. The simulator has a choice of 45 minutes of full instruction, 5 minutes of haptic arm only, or the option. Since the preparation of the material in the full teaching method in the simulator takes a long time, these steps were removed to show similarity with the control group. The skill practice option for an average of 5-10 minutes where all steps of the Checklist for Teaching Urinary Catheterization Skill can be applied was used. Urinary catheterization with 3D Systems Touch Haptic Simulator was explained by 1 researcher who was responsible for the Fundamentals of Nursing course. |
| Control | No intervention | –After the theoretical lesson, the control group was taken to Fundamentals of Nursing Skill Laboratory. 1 researcher, who is responsible for the Fundamentals of Nursing, was explained on the Simple Urinary Catheterization Model by applying the steps of "Checklist for Teaching Urinary Catheterization Skills". The students were allowed to ask questions and the questions asked were answered. Then all the students in the control group were taken to an empty class. The two researchers prepared the necessary materials for the urinary catheterization skill practice in the same way in separate rooms. The doors were closed to keep the environment calm during the application. One student was taken to each laboratory rooms in order not to be affected by each other. While the student was practicing, both researchers filled in the Checklist for Teaching Urinary Catheterization Skills. Satisfaction Questionnaire was given to the student who completed the application and asked to fill it. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being 18 years and over,
- enrolling for the first time in Fundamentals of Nursing course,
- participating in the study completely
- volunteering to participate
Key exclusion criteria (1 listed)
- being a graduate of Health 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 |
|---|---|---|
| 3D Systems Touch Haptic SimulatorThis simulator is computer-aided and allows us to see this application on the computer screen while practicing with a haptic arm. It gives real-like feedback in hand manipulations. The simulator has a choice of 45 minutes of full instruction, 5 minutes of haptic arm only, or the option. | Device | Intervention |
Primary outcome
Urinary Catheterization Skill Score
Time frame: through study completion, an average of 4 year
The 25-item checklist prepared by the researchers based on the literature includes the application steps of urinary catheterization skill
Satisfaction Questionnaire
Time frame: through study completion, an average of 2 year
The survey consists of 16 statements and the participants were asked to give a score for each instruction method on a five-item Likert-type scale between 1 and 5 (1-absolutely not agree, 5-absolutely agree). It is found that as the scale score average increases, students' satisfaction with the educational method increases, and as the scale score average decreases, their satisfaction with the education method decreases. In the evaluation of the scale, students are given a minimum of 16 and a maximum of 80 points for their satisfaction with their educational methods.
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 4 Dec 2020.
- Background: PubMed 24011752Ozturk D, Dinc L. Effect of web-based education on nursing students' urinary catheterization knowledge and skills. Nurse Educ Today. 2014 May;34(5):802-8. doi: 10.1016/j.nedt.2013.08.007. Epub 2013 Aug 20.
- Background: PubMed 21664014Jung EY, Park DK, Lee YH, Jo HS, Lim YS, Park RW. Evaluation of practical exercises using an intravenous simulator incorporating virtual reality and haptics device technologies. Nurse Educ Today. 2012 May;32(4):458-63. doi: 10.1016/j.nedt.2011.05.012. Epub 2011 Jun 12.
- 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.
Demet İnangil, Dr study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Systems Touch Haptic Simulator in people with Educational Problems, run by Istanbul Saglik Bilimleri 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 4 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 4 Dec 2020. 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?
Urinary Catheterization Skill Score (time frame: through study completion, an average of 4 year). The study lists 2 primary outcomes in all. 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 NCT04653233, 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 4 Dec 2020.