search
Back to results

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

Primary Purpose

Oral Dryness and Saliva Altered, Oral Manifestations, Swallowing Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
oral care augmented reality (AR)
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Dryness and Saliva Altered focused on measuring AR (augmented reality), Oral Care Behavior, Saliva Biomarker

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 under their care are between 65 and 75 years old. 3. The ADL(activity of daily living) evaluation score of the elderly under their care >= 61. Exclusion Criteria: 1. Older people with no teeth. 2. Older people with moderate to severe mental impairment. 3. Older people with damaged face. 4. Older people with NG(nasogastric) .

Sites / Locations

  • Kaohsiung Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group (EG)

Control group (CG)

Arm Description

Behavioral: The EG will receive augmented reality (AR) simulation training intervention with traditional classroom oral health education.

The CG only receive traditional classroom oral health education.

Outcomes

Primary Outcome Measures

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
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
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
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.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 3, 2023
Last Updated
July 9, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05938166
Brief Title
The Effects of Using Augmented Reality (AR) Simulation System to Train Foreign Care Workers.
Official Title
The Effects of Using Augmented Reality (AR) Simulation System to Train Foreign Care Workers on Function of the Older People.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the effect of augmented reality (AR) simulation training intervention of foreign care workers on the oral function of older people. This randomized controlled trial included experimental group: AR group (EG) and control group(CG), respectively. The EG will receive augmented reality (AR) simulation training intervention with traditional classroom oral health education. The CG only receive traditional classroom oral health education.
Detailed Description
A randomized experimental design was used. foreign care workers whose aged 21 to 65 years and by cared older peoples whose aged 65 to 75 years were recruited through community C site in Kaohsiung city. Each group was expected for 80 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), and masticatory efficiency (MoE) at baseline (Time 1), three months (Time 2) and six months (Time 3) follow-ups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Dryness and Saliva Altered, Oral Manifestations, Swallowing Disorder
Keywords
AR (augmented reality), Oral Care Behavior, Saliva Biomarker

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group (EG)
Arm Type
Experimental
Arm Description
Behavioral: The EG will receive augmented reality (AR) simulation training intervention with traditional classroom oral health education.
Arm Title
Control group (CG)
Arm Type
No Intervention
Arm Description
The CG only receive traditional classroom oral health education.
Intervention Type
Device
Intervention Name(s)
oral care augmented reality (AR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tongue Coating Index(TCI)
Description
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
Title
Tongue Coating Index(TCI)
Description
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
Title
Tongue Coating Index(TCI)
Description
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
Title
Oral Dryness Status
Description
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
Title
Oral Dryness Status
Description
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
Title
Oral Dryness Status
Description
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
Title
Lip-Tongue Motor Function
Description
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
Title
Lip-Tongue Motor Function
Description
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
Title
Lip-Tongue Motor Function
Description
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
Title
Maximum tongue pressure (MTP)
Description
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.
Time Frame
Change from Baseline Maximum tongue pressure status at 1-month after intervention
Title
Maximum tongue pressure (MTP)
Description
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.
Time Frame
Change from Baseline Maximum tongue pressure status at 2-month after intervention
Title
Maximum tongue pressure (MTP)
Description
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.
Time Frame
Change from Baseline Maximum tongue pressure status at 3-month after intervention
Title
Masticatory Function
Description
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.
Time Frame
Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention status at 3-month after intervention
Title
Masticatory Function
Description
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.
Time Frame
Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention status at 3-month after intervention
Title
Masticatory Function
Description
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.
Time Frame
Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention status at 3-month after intervention
Title
Saliva Swallowing Test(RSST)
Description
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
Title
Saliva Swallowing Test(RSST)
Description
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
Title
Saliva Swallowing Test(RSST)
Description
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 Outcome Measure Information:
Title
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
Description
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
Title
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
Description
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
Title
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 under their care are between 65 and 75 years old. 3. The ADL(activity of daily living) evaluation score of the elderly under their care >= 61. Exclusion Criteria: 1. Older people with no teeth. 2. Older people with moderate to severe mental impairment. 3. Older people with damaged face. 4. Older people with NG(nasogastric) .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
leu k hsun, Master
Phone
+886-7-3121101
Ext
2159
Email
leu1026@gmail.com
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
State/Province
Sanmin Dist
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
leu k hsun, Master
Phone
+886-7-3121101
Ext
2159
Email
leu1026@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35207706
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs