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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: VR-based training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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