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临床试验/NCT05938166
NCT05938166招募中不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Tongue Coating Index(TCI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

experimental group (EG-A)

Experimental

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.

干预措施: oral care augmented reality (AR) (Device)

experimental group (EG-A)

Experimental

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.

干预措施: video-based oral hygiene education course (Other)

experimental group (EG-B)

Experimental

The experimental of B group received a 50-minute video-based oral hygiene education course.

干预措施: video-based oral hygiene education course (Other)

Control Group

No Intervention

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

结局指标

主要结局

Tongue Coating Index(TCI)

时间窗: 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

Maximum tongue pressure (MTP)

时间窗: 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: 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.

Oral Dryness Status

时间窗: 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.

Masticatory Function

时间窗: 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 . 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.

Saliva Swallowing Test(RSST)

时间窗: 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.

Lip-Tongue Motor Function

时间窗: 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

Tongue Coating Index(TCI)

时间窗: 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

Tongue Coating Index(TCI)

时间窗: 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

Oral Dryness Status

时间窗: 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.

Oral Dryness Status

时间窗: 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.

Lip-Tongue Motor Function

时间窗: 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

Lip-Tongue Motor Function

时间窗: 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

Maximum tongue pressure (MTP)

时间窗: 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: 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.

Maximum tongue pressure (MTP)

时间窗: 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: 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.

Masticatory Function

时间窗: 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 . 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.

Masticatory Function

时间窗: 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 . 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.

Saliva Swallowing Test(RSST)

时间窗: 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.

Saliva Swallowing Test(RSST)

时间窗: 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.

次要结局

  • GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)(Change from Baseline at 6 month after intervention)
  • GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)(Change from Baseline at 1 month after intervention)
  • GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)(Change from Baseline at 3 month after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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