Virtual RealityNCT05436132
VR/AR Educational Module on Oral Care Practices for Home Care Worker
A study testing VR and AR oral healthcare curriculum training and traditional teaching methods oral healthcare curriculum in people with Virtual Reality and Augmented Reality, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is to evaluate the effect of the elderly oral care knowledge, attitude ,self-efficacy ,oral care behavior between the home care workers(HCW) in VR(Virtual reality)/AR(Augmented reality)group and control group after intervention. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Augmented Reality, Oral Care Performance
- What is being tested?
- VR and AR oral healthcare curriculum training and traditional teaching methods oral healthcare curriculum
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Oct 2021to 30 Dec 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- certificated home care workers in Taiwan.
Who cannot join
- aged above 65 were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Virtual Reality and Augmented Reality (VR/AR) Educational Module on Oral Care Practices for Home Care Worker
This study is to evaluate the effect of the elderly oral care knowledge, attitude ,self-efficacy ,oral care behavior between the home care workers(HCW) in VR(Virtual reality)/AR(Augmented reality)group and control group after intervention. Home care workers will be randomly assigned to the VR/AR group and the control group. Home care workers in the VR/AR group will use VR to learned about the oral care methods and processes in the different case. AR allows HCWs to actually operate cleaning teeth. The home care workers in the control group used traditional teaching methods for oral care. Baseline and follow-up survey were used to collect the data in oral care knowledge, attitude ,self-efficacy ,oral care behavior.
Read the detailed description
A randomized experimental design was used. Home care workers (HCWs) in the VR/AR group received 2.5 hours of VR(Virtual reality) and AR(Augmented reality) training. VR offered learners the standard oral care procedures under different physical and oral health conditions in elderly people and AR simulation training for the manual Bass brushing technique. The home care workers in the control group used traditional teaching methods for oral care. A self-administered questionnaire was used to collect data regarding oral care-related knowledge, attitude, self-efficacy, intention to assist in oral care behavior and behavior before and after the intervention, 3-month follow-up and 6-month follow-up. All participants finished the self-administered questionnaire within 10-15 minutes and handed it to researchers at VR/AR oral care training center in Kaohsiung Medical University.Generalized estimating equations (GEEs) was used to analyze the differences between pre-test, post-test and follow-ups.
- Conditions
- Virtual Reality, Augmented Reality, Oral Care Performance
- Being tested
- VR and AR oral healthcare curriculum training, traditional teaching methods oral healthcare curriculum
- Keywords
- Virtual reality, Augmented reality, Oral Care Performance, home care worker, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR and AR oral healthcare curriculum trainingBehavioural
HCWs in the VR/AR group received 2.5 hours VR and AR oral healthcare curriculum training. VR oral care training system was training the standard oral healthcare procedure for different physical and oral conditions in elderly people.AR oral care training system was training for the manual Bass brushing technique.
traditional teaching methods oral healthcare curriculumBehavioural
HCWs in the control group received 2.5 hours traditional teaching methods of oral healthcare curriculum training.
| Study group | Role | What they receive |
|---|---|---|
| VR/AR group | Experimental | Home care workers (HCW)HCWs in the VR/AR group received 2.5 hours of VR and AR training. VR offered learners the standard oral care procedures under different physical and oral health conditions in elderly people and AR simulation training for the manual Bass brushing technique. Receives: Behavioral: VR and AR oral healthcare curriculum training |
| Control group | Placebo comparator | The home care workers in the control group received 2.5 hours of traditional teaching methods for oral care. Receives: Behavioral: traditional teaching methods oral healthcare curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral care behavior
Eight statements were used to evaluate the behavior in assisting in oral care behavior Item including that" I take the initiative to assist the elderly to perform oral care ." All response was coded as zero (not) or one (yes).
Measured: Change from 3-month follow-up to 6-month follow-up. After two groups HCWs received the intervention, 3 months and 6 months HCWs would received follow-up questionnaire to finish the measurement.
Secondary outcomes (4)
Oral care-related knowledge
Ten statements were used to assess oral care-related knowledge. Item including that" Fluoride toothpaste for adults should have a fluoride content above 1000 ppm." A score of 0 (incorrect) and 1 (correct) was used for each statement. The total score ranged was 0-10.
Measured: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Attitude toward oral care
Seven statements were used to assessment the attitude toward oral care, including' oral cleansing is a part of elderly people daily body cleaning.' A score was used the Liker scale with rating from 1 (completely disagree) to 5 (completely agree) was used for each statement. The total score ranged was 7-35.
Measured: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Self-efficacy of oral care
Nine statements were used to measures the self-efficacy to oral care , including 'I am confident in helping elderly people brush their teeth with the modified Bass brushing technique.' A score was used the Liker scale with rating from 1 (completely disagree) to 5 (completely agree) was used for each statement. The total score was 9-45.
Measured: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Intention to assist in oral care behavior
Eight statements were used to evaluate the intention to assist in oral care behavior , including 'I will take the initiative to assist the elderly in using the modified Bass brushing technique to brush their teeth.' A score was used the Liker scale with rating from 1 (completely disagree) to 5 (completely agree) was used for each statement. The total score ranged was 8-40.
Measured: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start13 Oct 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Ling Huang, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436132
- Sponsor's protocol ID
- KMUHIRB- F(I)-20200098
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality and Augmented Reality (VR/AR) Educational Module on Oral Care Practices for Home Care Worker
- ClinicalTrials.gov ID
- NCT05436132
- Acronym / sponsor ID
- KMUHIRB- F(I)-20200098
- Conditions
- Virtual Reality, Augmented Reality, Oral Care Performance
- Keywords
- Virtual reality, Augmented reality, Oral Care Performance, home care worker, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Jun 2022 (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 study is to evaluate the effect of the elderly oral care knowledge, attitude ,self-efficacy ,oral care behavior between the home care workers(HCW) in VR(Virtual reality)/AR(Augmented reality)group and control group after intervention. Home care workers will be randomly assigned to the VR/AR group and the control group. Home care workers in the VR/AR group will use VR to learned about the oral care methods and processes in the different case. AR allows HCWs to actually operate cleaning teeth. The home care workers in the control group used traditional teaching methods for oral care. Baseline and follow-up survey were used to collect the data in oral care knowledge, attitude ,self-efficacy ,oral care behavior.
Detailed description
A randomized experimental design was used. Home care workers (HCWs) in the VR/AR group received 2.5 hours of VR(Virtual reality) and AR(Augmented reality) training. VR offered learners the standard oral care procedures under different physical and oral health conditions in elderly people and AR simulation training for the manual Bass brushing technique. The home care workers in the control group used traditional teaching methods for oral care. A self-administered questionnaire was used to collect data regarding oral care-related knowledge, attitude, self-efficacy, intention to assist in oral care behavior and behavior before and after the intervention, 3-month follow-up and 6-month follow-up. All participants finished the self-administered questionnaire within 10-15 minutes and handed it to researchers at VR/AR oral care training center in Kaohsiung Medical University.Generalized estimating equations (GEEs) was used to analyze the differences between pre-test, post-test and follow-ups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR/AR group | Experimental | Behavioral: VR and AR oral healthcare curriculum trainingHome care workers (HCW)HCWs in the VR/AR group received 2.5 hours of VR and AR training. VR offered learners the standard oral care procedures under different physical and oral health conditions in elderly people and AR simulation training for the manual Bass brushing technique. |
| Control group | Placebo comparator | Behavioral: traditional teaching methods oral healthcare curriculumThe home care workers in the control group received 2.5 hours of traditional teaching methods for oral care. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- certificated home care workers in Taiwan.
Key exclusion criteria (1 listed)
- aged above 65 were excluded.
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 |
|---|---|---|
| VR and AR oral healthcare curriculum trainingHCWs in the VR/AR group received 2.5 hours VR and AR oral healthcare curriculum training. VR oral care training system was training the standard oral healthcare procedure for different physical and oral conditions in elderly people.AR oral care training system was training for the manual Bass brushing technique. | Behavioural | VR/AR group |
| traditional teaching methods oral healthcare curriculumHCWs in the control group received 2.5 hours traditional teaching methods of oral healthcare curriculum training. | Behavioural | Control group |
Primary outcome
oral care behavior
Time frame: Change from 3-month follow-up to 6-month follow-up. After two groups HCWs received the intervention, 3 months and 6 months HCWs would received follow-up questionnaire to finish the measurement.
Eight statements were used to evaluate the behavior in assisting in oral care behavior Item including that" I take the initiative to assist the elderly to perform oral care ." All response was coded as zero (not) or one (yes).
4 secondary outcomes
Oral care-related knowledge
Time frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Attitude toward oral care
Time frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Self-efficacy of oral care
Time frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Intention to assist in oral care behavior
Time frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately.
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 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Virtual Reality
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain, Anxiety
Recruiting
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Anxiety
Not yet recruiting
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
Hematologic Cancer
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 principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR and AR oral healthcare curriculum training and traditional teaching methods oral healthcare curriculum in people with Virtual Reality and Augmented Reality, 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 1 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 Oct 2023. 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. Some participants in this study may receive a placebo. 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 behavior (time frame: Change from 3-month follow-up to 6-month follow-up. After two groups HCWs received the intervention, 3 months and 6 months HCWs would received follow-up questionnaire to finish the measurement.). 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 4 Oct 2023.