The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.

The Effects of Using Augmented Reality (AR) System to Train Foreign Care on Salivary Biomarker and Oral Function of the Elderly People

The aim of this study was to evaluate the effect of augmented reality (AR) system training intervention of foreign care workers on the salivary biomarker and oral function of older people.

This randomized controlled trial included experimental group: AR group (EG-A) Video group (EG-B) and control group(CG), respectively. The EG-A will receive augmented reality (AR) system training intervention with AR tooth-cleaning skills session course add video-based oral hygiene education course . The EG-B receive video-based oral hygiene education course and The CG only receive only a leaflet.

Study Overview

• Status: Recruiting
• Conditions: Oral Manifestations; Swallowing Disorder; Oral Dryness and Saliva Altered
• Intervention / Treatment: Device: oral care augmented reality (AR); Other: video-based oral hygiene education course

Detailed Description

A randomized experimental design was used. Female foreign care workers whose aged 21 to 65 years and by cared older peoples whose aged 65 to 75 years were recruited through community-based site of long-term care service in Kaohsiung city. Each group was expected for 12 care workers and by cared older peoples who each group. G*Power (version 3.1.9.4) was used for power analysis.

All foreign care workers whose participants will underwent questionnaire examination at baseline and at 1-month, 3-month, 6-month follow-ups. The information of foreign care workers regarding oral care cognition, attitude, self-efficacy, and oral care behavior intention will be collected by a self-report questionnaire before and after intervention.

Each by cared older peoples will be evaluation oral hygiene and function by oral hygienist, and will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up. Older people by cared will assess plaque control record (PCR), tongue coating index (TCI), repetitive saliva swallowing test (RSST), oral diadochokinetic (DDK), oral moisture degree (OMD),masticatory efficiency (MoE) and salivary biomarker at baseline (Time 1), three months (Time 2) and six months (Time 3) follow-ups.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: leu k hsun, Master; Phone Number: 2159 +886-7-3121101; Email: leu1026@gmail.com

Study Locations

• Taiwan
  • Sanmin Dist
    • Kaohsiung, Sanmin Dist, Taiwan, 807
      • Recruiting
      • Kaohsiung Medical University
      • Contact: leu k hsun, Master; Phone Number: 2159 +886-7-3121101; Email: leu1026@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. The Indonesian caregivers who are employed in Kaohsiung City are aged between 21 and 65 and have simple Chinese communication skills.
• 2. The elderly people being cared for is over 65 years old.

Exclusion Criteria:

• 1. Elderly people who are unable to cooperate with instructions.
• 2. Elderly people with facial impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group (EG-A); Behavioral: The experimental of A group received a 40-minute AR tooth-cleaning skills session and a 50-minute video-based oral hygiene education course.	Device: oral care augmented reality (AR); Augmented reality (AR) is an extension of perceptible reality, whereby additional information, such as texts or virtual objects, can be displayed in the user's field of vision.The oral care augmented reality (AR) simulation training can train foreign care workers by switching languages (Indonesian) and therefore reduce language-related learning barriers.; Other: video-based oral hygiene education course; 50-minute video-based oral hygiene education course
Experimental: experimental group (EG-B); The experimental of B group received a 50-minute video-based oral hygiene education course.	Other: video-based oral hygiene education course; 50-minute video-based oral hygiene education course
No Intervention: Control Group; The CG only receive only a booklet of traditional classroom oral health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue Coating Index(TCI)	The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible. Score 1: Tongue coating thin, papillae of tongue visible. Score 2: Tongue coating very thick, papillae of tongue not visible. Range= 0 to 18 Score	Change from Baseline TCI at 1-month after intervention
Tongue Coating Index(TCI)	The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible. Score 1: Tongue coating thin, papillae of tongue visible. Score 2: Tongue coating very thick, papillae of tongue not visible. Range= 0 to 18 Score	Change from Baseline TCI at 3-month after intervention
Tongue Coating Index(TCI)	The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible. Score 1: Tongue coating thin, papillae of tongue visible. Score 2: Tongue coating very thick, papillae of tongue not visible. Range= 0 to 18 Score	Change from Baseline TCI at 6-month after intervention
Oral Dryness Status	The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min. Oral dryness: 2 g/2min.	Change from Baseline Oral Dryness Status at 1-month after intervention
Oral Dryness Status	The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min. Oral dryness: 2 g/2min.	Change from Baseline Oral Dryness Status at 3-month after intervention
Oral Dryness Status	The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min. Oral dryness: 2 g/2min.	Change from Baseline Oral Dryness Status at 6-month after intervention
Lip-Tongue Motor Function	The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds Ta:times /per 15 seconds Ka:times /per 15 seconds	Change from Baseline lip-tongue motor function Status at 1-month after intervention
Lip-Tongue Motor Function	The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds Ta:times /per 15 seconds Ka:times /per 15 seconds	Change from Baseline lip-tongue motor function Status at 3-month after intervention
Lip-Tongue Motor Function	The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds Ta:times /per 15 seconds Ka:times /per 15 seconds	Change from Baseline lip-tongue motor function Status at 6-month after intervention
Masticatory Function	The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors .; light green: very poor chewing ability.; light yellow: poor chewing ability.; light pink: no good chewing ability.; pink: good chewing ability.; red: very good chewing ability.	Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention status at 3-month after intervention
Masticatory Function	The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors .; light green: very poor chewing ability.; light yellow: poor chewing ability.; light pink: no good chewing ability.; pink: good chewing ability.; red: very good chewing ability.	Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention status at 3-month after intervention
Masticatory Function	The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors .; light green: very poor chewing ability.; light yellow: poor chewing ability.; light pink: no good chewing ability.; pink: good chewing ability.; red: very good chewing ability.	Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention status at 3-month after intervention
Saliva Swallowing Test(RSST)	The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.	Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention
Saliva Swallowing Test(RSST)	The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.	Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention
Saliva Swallowing Test(RSST)	The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.	Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention
Maximum tongue pressure (MTP)	The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: First times / Maximum Kpa value.; Second times / Maximum Kpa value.; Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.	Change from Baseline Maximum tongue pressure status at 1-month after intervention
Maximum tongue pressure (MTP)	The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: First times / Maximum Kpa value.; Second times / Maximum Kpa value.; Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.	Change from Baseline Maximum tongue pressure status at 2-month after intervention
Maximum tongue pressure (MTP)	The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: First times / Maximum Kpa value.; Second times / Maximum Kpa value.; Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.	Change from Baseline Maximum tongue pressure status at 3-month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)	The GOHAI-T of 12 questions was assessment using self-assessment oral health questionnaire. Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.	Change from Baseline at 1 month after intervention
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)	The GOHAI-Scale of 12 questions was assessment using self-assessment oral health questionnaire. Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.	Change from Baseline at 3 month after intervention
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)	The GOHAI-Scale of 12 questions was assessment using self-assessment oral health questionnaire. Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.	Change from Baseline at 6 month after intervention

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

General Publications

• Chang AH, Lin PC, Lin PC, Lin YC, Kabasawa Y, Lin CY, Huang HL. Effectiveness of Virtual Reality-Based Training on Oral Healthcare for Disabled Elderly Persons: A Randomized Controlled Trial. J Pers Med. 2022 Feb 4;12(2):218. doi: 10.3390/jpm12020218.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: AR (augmented reality); Oral Care Behavior; Saliva Biomarker
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders; Oral Manifestations
• Other Study ID Numbers: KMUHIRB-SV(II)-20230019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No