- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05043909
The Effects of Virtual Reality and Augmented Reality Training System on Elderly Oral Care Skill for Oral Hygiene and Nursing Students
September 5, 2021 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Virtual Reality Training System on Oral Health Care for Dependency Elderly in Oral Hygiene Students: A Randomized Controlled Trial
Virtual reality (VR) has been proposed as a promising technology for education since the combination of immersive and interactive features enables experiential learning.
The study aimed to evaluate the effectiveness of VR-based training on oral health care for dependency elderly among oral hygiene students.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized controlled trial was conducted.
Overall, the study recruited students from third grade of Department of Oral Hygiene students in Kaohsiung Medical University during 2021.
The participants were randomly assigned to virtual-reality experimental (EG; n = 11) and control (CG; n = 12) groups.
The students in EG received a 2-hour VR training for elderly oral health care at 2-week (Time 2), 4-week (Time 3) and 6-week (Time 4) follow-ups.
Each student collected the data by a self-administrated questionnaire before and immediately after each of the intervention.
Linear regression in generalized estimating equations (GEE) compare the differences between both groups.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
San Min District
-
Kaohsiung, San Min District, Taiwan
- Kaohsiung Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 21 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- third grade of Department of Oral Hygiene students in Kaohsiung Medical University during the 2021 academic semester
- Participants have to take both the courses of 'Basic Medical Nursing Care' and 'Oral Health Care for Community People and Long-term Care Residents' before intervention.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group (EG)
The students in EG received VR-based training for elderly oral health care at 2-week (Time 2), 4-week (Time 3), and 6-week (Time 4) follow-ups.
The learning module was divided into three sessions according to the physical condition (1) Mild disability, (2) Semi-disability, (3) Total disability and oral condition, (1) wearing dentures, (2) missing teeth of the elderly.
Students simulate the different physical and oral conditions of the elderly through virtual situations and provide suitable oral care methods.
The whole training session took approximately two hours for each student; First, students were first given a short introduction to the VR system's use (10 minutes).
Second, they were able to carry out oral care for the elderly while wearing VR goggles and using hand-controllers with the teaching and audio guides during the process (90 minutes), and an evaluation was taken after the intervention (20 minutes).
|
Students simulate the different physical and oral conditions of the elderly through virtual situations and provide suitable oral care methods.
The whole training session took approximately two hours for each student; First, students were first given a short introduction to the VR system's use (10 minutes).
Second, they were able to carry out oral care for the elderly while wearing VR goggles and using hand-controllers with the teaching and audio guides during the process (90 minutes), and an evaluation was taken after the intervention (20 minutes).
|
|
No Intervention: Control Group (CG)
The students in CG do not receive any of the interventions.
However, the same VR-based curriculum of oral health care on dependency elderly were provided at the end of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Elderly oral care-related knowledge
Time Frame: Change from Baseline knowledge at 2-, 4-, 6-week follow-ups after the interventions
|
Twenty items measured elderly oral care-related knowledge; for example, 'There is no need to consider the size of the interdental brush.' Possible responses included True (1), False (0), and I do not know (0), with possible scores ranged from 0 to 20; a higher score indicated a higher degree of oral-care-related knowledge.
The KR-20 coefficient was 0.56 for this scale
|
Change from Baseline knowledge at 2-, 4-, 6-week follow-ups after the interventions
|
|
Attitude toward elderly oral care
Time Frame: Change from Baseline attitude at 2-, 4-, 6-week follow-ups after the interventions
|
Seven items measured attitude toward elderly oral care, for example, 'Assist disabled elderly to clean their teeth is annoying.'
Each item was scored on a five-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Possible scores ranged from 5 to 35; a higher score indicated a more positive attitude toward oral care for the elderly.
Cronbach's alpha was 0.70 for this scale.
|
Change from Baseline attitude at 2-, 4-, 6-week follow-ups after the interventions
|
|
Self-efficacy of elderly oral care
Time Frame: Change from Baseline self-efficacy at 2-, 4-, 6-week follow-ups after the interventions
|
Eleven items were used to evaluate the self-efficacy of elderly oral care.
Students indicated their degrees of agreement with statements related to perceptions of personal ability concerning oral care for the elderly.
For example, 'I am confident to remind disable elderly having regular dental visits every six months.'
Each item was scored on a five-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Possible scores ranged from 5 to 55; a higher score indicated more substantial confidence toward oral care for the elderly.
Cronbach's alpha was 0.87 for this scale.
|
Change from Baseline self-efficacy at 2-, 4-, 6-week follow-ups after the interventions
|
|
Intention to elderly oral care behaviors
Time Frame: Change from Baseline intentions at 2-, 4-, 6-week follow-ups after the interventions
|
Twelve items were used to evaluate the intention to elderly oral care behavior for elderly.
Students indicated their goals of adding new behaviors or modifying existing behaviors of oral care for the elderly.
For example, 'I will take the initiative to assist disabled elderly to clean their dentures.'
Each item was scored on a five-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree).
|
Change from Baseline intentions at 2-, 4-, 6-week follow-ups after the interventions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2020
Primary Completion (Actual)
April 23, 2021
Study Completion (Actual)
April 23, 2021
Study Registration Dates
First Submitted
August 27, 2021
First Submitted That Met QC Criteria
September 5, 2021
First Posted (Actual)
September 14, 2021
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 5, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- KMUHIRB-SV(II)-20200071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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