- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436132
VR/AR Educational Module on Oral Care Practices for Home Care Worker
October 2, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.
Study Overview
Status
Completed
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 Type
Interventional
Enrollment (Actual)
173
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
-
-
Sanmin Dist
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Kaohsiung city, Sanmin Dist, Taiwan, 80708
- 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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- certificated home care workers in Taiwan.
Exclusion Criteria:
- aged above 65 were excluded.
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: VR/AR group
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.
|
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.
|
Placebo Comparator: Control group
The home care workers in the control group received 2.5 hours of traditional teaching methods for oral care.
|
HCWs in the control group received 2.5 hours traditional teaching methods of oral healthcare curriculum training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hsiao-Ling Huang, Kaohsiung Medical University
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 13, 2021
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
June 21, 2022
First Submitted That Met QC Criteria
June 25, 2022
First Posted (Actual)
June 28, 2022
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- KMUHIRB- F(I)-20200098
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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