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RecruitingNCT05938166Updated Mar 7, 2025

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

An interventional study of oral care augmented reality (AR) and video-based oral hygiene education course in Oral Dryness and Saliva Altered, Oral Manifestations and Swallowing Disorder, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Oral Dryness and Saliva Altered
  • Oral Manifestations
  • Swallowing Disorder

Keywords

  • AR (augmented reality)
  • Oral Care Behavior
  • Saliva Biomarker
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's planned enrollment of 42 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

    1. Elderly people who are unable to cooperate with instructions.
    1. Elderly people with facial impairment.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
42 participants (estimated)

Study arms

  • 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) · Other: 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

  • No intervention
    Control Group

    The CG only receive only a booklet of traditional classroom oral health education

Interventions

  • Deviceoral 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.

  • Othervideo-based oral hygiene education course

    50-minute video-based oral hygiene education course

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from Baseline TCI at 1-month after intervention

  2. 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

    Time frame: Change from Baseline TCI at 3-month after intervention

  3. 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

    Time frame: Change from Baseline TCI at 6-month after intervention

  4. 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.

    Time frame: Change from Baseline Oral Dryness Status at 1-month after intervention

  5. 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.

    Time frame: Change from Baseline Oral Dryness Status at 3-month after intervention

  6. 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.

    Time frame: Change from Baseline Oral Dryness Status at 6-month after intervention

  7. 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

    Time frame: Change from Baseline lip-tongue motor function Status at 1-month after intervention

  8. 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

    Time frame: Change from Baseline lip-tongue motor function Status at 3-month after intervention

  9. 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

    Time frame: Change from Baseline lip-tongue motor function Status at 6-month after intervention

  10. Maximum tongue pressure (MTP)

    The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: 1. First times / Maximum Kpa value. 2. Second times / Maximum Kpa value. 3. Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.

    Time frame: Change from Baseline Maximum tongue pressure status at 1-month after intervention

  11. Maximum tongue pressure (MTP)

    The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: 1. First times / Maximum Kpa value. 2. Second times / Maximum Kpa value. 3. Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.

    Time frame: Change from Baseline Maximum tongue pressure status at 2-month after intervention

  12. Maximum tongue pressure (MTP)

    The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: 1. First times / Maximum Kpa value. 2. Second times / Maximum Kpa value. 3. Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.

    Time frame: Change from Baseline Maximum tongue pressure status at 3-month after intervention

  13. 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 . 1. light green: very poor chewing ability. 2. light yellow: poor chewing ability. 3. light pink: no good chewing ability. 4. pink: good chewing ability. 5. red: very good chewing ability.

    Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention status at 3-month after intervention

  14. 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 . 1. light green: very poor chewing ability. 2. light yellow: poor chewing ability. 3. light pink: no good chewing ability. 4. pink: good chewing ability. 5. red: very good chewing ability.

    Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention status at 3-month after intervention

  15. 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 . 1. light green: very poor chewing ability. 2. light yellow: poor chewing ability. 3. light pink: no good chewing ability. 4. pink: good chewing ability. 5. red: very good chewing ability.

    Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention status at 3-month after intervention

  16. 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.

    Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention

  17. 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.

    Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention

  18. 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.

    Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention

Secondary outcomes

  1. 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.

    Time frame: Change from Baseline at 1 month after intervention

  2. 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.

    Time frame: Change from Baseline at 3 month after intervention

  3. 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.

    Time frame: Change from Baseline at 6 month after intervention

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Medical University
    Kaohsiung, Sanmin Dist 807, Taiwan
    Recruiting
08

References and documents

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. PubMed 35207706 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05938166
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Jul 10, 2023
Start date
Jan 3, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 7, 2025

Study contacts

leu k hsun, Master
Contact
leu1026@gmail.com
+886-7-3121101 ext. 2159

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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