HealthyNCT05958238
The Effects of AR and VR Oral Care Training System on Oral Healthcare for Elderly in Eldercare Students
A study testing AR/VR oral care training system and Traditional classroom teaching in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to assess the effectiveness of an AR/VR oral care training system on the knowledge, attitudes, self-efficacy, and behavioral intentions of students majoring in geriatric care. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AR/VR oral care training system and Traditional classroom teaching
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2023to 21 Dec 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-30 years
- Students majoring in geriatric care
- Fooyin University of Technology
Who cannot join
- Transfer student
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: The Effects of Augmented Reality (AR) and Virtual Reality (VR) Oral Care Training System on Oral Healthcare for Elderly in Eldercare Students
The aim of this study is to assess the effectiveness of an AR/VR oral care training system on the knowledge, attitudes, self-efficacy, and behavioral intentions of students majoring in geriatric care.
Read the detailed description
A randomized controlled trial design will be employed, students randomly assigned to either the experimental group or the control group. The experimental group will receive a total of two sessions of AR/VR oral care training, each lasting two hours, with the intervention taking place two weeks and four weeks after completing the pre-test questionnaire. The control group, on the other hand, will receive traditional oral care instruction for thirty minutes.
Each student collected the data by a self-administered questionnaire before and immediately after each intervention.
Linear regression in generalized estimating equations (GEE) compares the differences between both groups.
- Conditions
- Healthy
- Being tested
- AR/VR oral care training system, Traditional classroom teaching
- Keywords
- Elderly, Medical Education, Augmented Reality, Virtual Reality, Oral Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR/VR oral care training systemDevice
Students simulated the treatment of the elderly with different physical and oral conditions using virtual situations and employed suitable oral care methods depending on each situation through VR. They learned the Bass brushing technique, the interdental brush cleaning method, and the soft tissue cleaning method through AR.
Traditional classroom teachingOther
The well-trained oral hygienist provided traditional oral care instruction with the same teaching content in the AR/VR-based training system.
| Study group | Role | What they receive |
|---|---|---|
| AR/VR group | Experimental | Students in EG recieved a 2-hour AR/VR training for elderly oral healthcare at 2-week and 4-week follow-ups. Receives: Device: AR/VR oral care training system |
| Traditional teaching group | Active comparator | Students in the CG received thirty minutes oral care training class with same teaching content in AR/VR-based training system by well-trained oral hygienist. Receives: Other: Traditional classroom teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral care-related knowledge
20 statements were used to measure students' knowledge of the oral care of elderly. Ex: Dentures should be cleaned with toothpaste every day. With possible scores of 0-20, a higher score indicated a higher degree of oral care-related knowledge.
Measured: Change from Baseline at 2-week after intervention
Oral care-related knowledge
20 statements were used to measure students' knowledge of the oral care of elderly. Ex: Dentures should be cleaned with toothpaste every day. With possible scores of 0-20, a higher score indicated a higher degree of oral care-related knowledge.
Measured: Change from Baseline at 4-week after intervention
Attitude toward oral care
7 statements were used to measure students' attitude toward oral care of elderly. Ex: Oral care is as important as physical care for the elderly with disabilities. With possible scores of 7-35, a higher score indicated a more positive attitude toward oral care for elderly.
Measured: Change from Baseline at 2-week after intervention
Attitude toward oral care
7 statements were used to measure students' attitude toward oral care of elderly. Ex: Oral care is as important as physical care for the elderly with disabilities. With possible scores of 7-35, a higher score indicated a more positive attitude toward oral care for elderly.
Measured: Change from Baseline at 4-week after intervention
Self-efficacy of oral care
11 statements were used to evaluate students' self-efficacy in provideng the elderly with oral care. Ex: I am confident about assisting the elderly with disabilities in performing soft tissue cleaning. With possible scores of 11-55, a higher score indicated a greater degree of confidence.
Measured: Change from Baseline at 2-week after intervention
Self-efficacy of oral care
11 statements were used to evaluate students' self-efficacy in provideng the elderly with oral care. Ex: I am confident about assisting the elderly with disabilities in performing soft tissue cleaning. With possible scores of 11-55, a higher score indicated a greater degree of confidence.
Measured: Change from Baseline at 4-week after intervention
Intention to oral care behaviors
12 statements were used to measure students' intention to assist elderly. Ex: I will take the initiative to check the suitability of oral care tools for the elderly with disabilities. With possible scores of 12-60, a higher score indicated a higher possibility of performing the behaviors.
Measured: Change from Baseline at 2-week after intervention
Intention to oral care behaviors
12 statements were used to measure students' intention to assist elderly. Ex: I will take the initiative to check the suitability of oral care tools for the elderly with disabilities. With possible scores of 12-60, a higher score indicated a higher possibility of performing the behaviors.
Measured: Change from Baseline at 4-week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start7 Apr 2023
- Primary completion30 Nov 2023
- Study completion21 Dec 2023
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 Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HSIAO- LING HUANG, Dr.PH, Principal investigator, Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958238
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20230006
- Status last verified
- Apr 2023
- First submitted
- 5 Jul 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Augmented Reality (AR) and Virtual Reality (VR) Oral Care Training System on Oral Healthcare for Elderly in Eldercare Students
- ClinicalTrials.gov ID
- NCT05958238
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20230006
- Conditions
- Healthy
- Keywords
- Elderly, Medical Education, Augmented Reality, Virtual Reality, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 24 Jul 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.
The aim of this study is to assess the effectiveness of an AR/VR oral care training system on the knowledge, attitudes, self-efficacy, and behavioral intentions of students majoring in geriatric care.
Detailed description
A randomized controlled trial design will be employed, students randomly assigned to either the experimental group or the control group. The experimental group will receive a total of two sessions of AR/VR oral care training, each lasting two hours, with the intervention taking place two weeks and four weeks after completing the pre-test questionnaire. The control group, on the other hand, will receive traditional oral care instruction for thirty minutes.
Each student collected the data by a self-administered questionnaire before and immediately after each intervention.
Linear regression in generalized estimating equations (GEE) compares the differences between both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR/VR group | Experimental | Device: AR/VR oral care training systemStudents in EG recieved a 2-hour AR/VR training for elderly oral healthcare at 2-week and 4-week follow-ups. |
| Traditional teaching group | Active comparator | Other: Traditional classroom teachingStudents in the CG received thirty minutes oral care training class with same teaching content in AR/VR-based training system by well-trained oral hygienist. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-30 years
- Students majoring in geriatric care
- Fooyin University of Technology
Key exclusion criteria (1 listed)
- Transfer student
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 |
|---|---|---|
| AR/VR oral care training systemStudents simulated the treatment of the elderly with different physical and oral conditions using virtual situations and employed suitable oral care methods depending on each situation through VR. They learned the Bass brushing technique, the interdental brush cleaning method, and the soft tissue cleaning method through AR. | Device | AR/VR group |
| Traditional classroom teachingThe well-trained oral hygienist provided traditional oral care instruction with the same teaching content in the AR/VR-based training system. | Other | Traditional teaching group |
Primary outcome
Oral care-related knowledge
Time frame: Change from Baseline at 2-week after intervention
20 statements were used to measure students' knowledge of the oral care of elderly. Ex: Dentures should be cleaned with toothpaste every day. With possible scores of 0-20, a higher score indicated a higher degree of oral care-related knowledge.
Oral care-related knowledge
Time frame: Change from Baseline at 4-week after intervention
20 statements were used to measure students' knowledge of the oral care of elderly. Ex: Dentures should be cleaned with toothpaste every day. With possible scores of 0-20, a higher score indicated a higher degree of oral care-related knowledge.
Attitude toward oral care
Time frame: Change from Baseline at 2-week after intervention
7 statements were used to measure students' attitude toward oral care of elderly. Ex: Oral care is as important as physical care for the elderly with disabilities. With possible scores of 7-35, a higher score indicated a more positive attitude toward oral care for elderly.
Attitude toward oral care
Time frame: Change from Baseline at 4-week after intervention
7 statements were used to measure students' attitude toward oral care of elderly. Ex: Oral care is as important as physical care for the elderly with disabilities. With possible scores of 7-35, a higher score indicated a more positive attitude toward oral care for elderly.
Self-efficacy of oral care
Time frame: Change from Baseline at 2-week after intervention
11 statements were used to evaluate students' self-efficacy in provideng the elderly with oral care. Ex: I am confident about assisting the elderly with disabilities in performing soft tissue cleaning. With possible scores of 11-55, a higher score indicated a greater degree of confidence.
Self-efficacy of oral care
Time frame: Change from Baseline at 4-week after intervention
11 statements were used to evaluate students' self-efficacy in provideng the elderly with oral care. Ex: I am confident about assisting the elderly with disabilities in performing soft tissue cleaning. With possible scores of 11-55, a higher score indicated a greater degree of confidence.
Intention to oral care behaviors
Time frame: Change from Baseline at 2-week after intervention
12 statements were used to measure students' intention to assist elderly. Ex: I will take the initiative to check the suitability of oral care tools for the elderly with disabilities. With possible scores of 12-60, a higher score indicated a higher possibility of performing the behaviors.
Intention to oral care behaviors
Time frame: Change from Baseline at 4-week after intervention
12 statements were used to measure students' intention to assist elderly. Ex: I will take the initiative to check the suitability of oral care tools for the elderly with disabilities. With possible scores of 12-60, a higher score indicated a higher possibility of performing the behaviors.
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 22 Oct 2024.
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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.
HSIAO- LING HUANG, Dr.PH principal investigator
Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR/VR oral care training system and Traditional classroom teaching in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 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 22 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 Taiwan. 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?
Oral care-related knowledge (time frame: Change from Baseline at 2-week after intervention). The study lists 8 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 22 Oct 2024.