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NCT Number: NCT05938166

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

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.

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Key information

Conditions

Oral Dryness and Saliva Altered Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Mouth Diseases Oral Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Salivary Gland Diseases Signs and Symptoms Stomatognathic Diseases Swallowing Disorder Xerostomia

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University

Kaohsiung City, Sanmin Dist, 807, Taiwan

Location status: Recruiting

Location contact

leu k hsun, Master

CONTACT

[email protected]

+886-7-3121101 ext. 2159

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral care augmented reality (AR)

Device

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.

video-based oral hygiene education course

Other

50-minute video-based oral hygiene education course

Primary outcomes

  1. Tongue Coating Index(TCI)

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

    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

  2. Tongue Coating Index(TCI)

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

    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

  3. Tongue Coating Index(TCI)

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

    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

  4. Oral Dryness Status

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

    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.

  5. Oral Dryness Status

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

    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.

  6. Oral Dryness Status

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

    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.

  7. Lip-Tongue Motor Function

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

    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

  8. Lip-Tongue Motor Function

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

    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

  9. Lip-Tongue Motor Function

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

    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

  10. Maximum tongue pressure (MTP)

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

    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.

  11. Maximum tongue pressure (MTP)

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

    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.

  12. Maximum tongue pressure (MTP)

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

    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.

  13. Masticatory Function

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

    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.

  14. Masticatory Function

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

    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.

  15. Masticatory Function

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

    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.

  16. Saliva Swallowing Test(RSST)

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

    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.

  17. Saliva Swallowing Test(RSST)

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

    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.

  18. Saliva Swallowing Test(RSST)

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

    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.

Secondary outcomes

  1. GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)

    Time frame: Change from Baseline at 1 month after intervention

    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.

  2. GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)

    Time frame: Change from Baseline at 3 month after intervention

    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.

  3. GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)

    Time frame: Change from Baseline at 6 month after intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

leu k hsun, Master

CONTACT

[email protected]

+886-7-3121101 ext. 2159

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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