Comparing a Mobile App, AI Chatbot, and Printed Materials to Improve Parents' Dental Trauma Knowledge and Emergency Decisions (TRAUMA-AI)
Comparative Effectiveness of a Mobile Application, an Artificial Intelligence Chatbot, and Traditional Print Resources on Parental Knowledge and Emergency Decision-Making for Dental Trauma in Children: A Three-Arm, Parallel-Group, Randomized Controlled Trial
Dental trauma in children may require prompt decisions by parents or caregivers. This three-arm randomized trial will compare a mobile application, an artificial intelligence chatbot, and a printed dental-trauma first-aid booklet as methods of delivering parental education. Approximately 220 parents or legal guardians will be allocated in a 1:1:1 ratio and will receive their assigned educational resource over four weeks. Parental dental-trauma knowledge and accuracy of responses to simulated emergency scenarios will be assessed at four weeks, with follow-up assessments at 12 weeks. Additional measures include confidence, usability, engagement, recognition of avulsion management, and anxiety. The study is planned in Selangor, Malaysia.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This interventional, parallel-group, three-arm randomized controlled trial will evaluate educational modalities for parents/legal guardians of children. Participants will be recruited from the paediatric dentistry outpatient clinic and community/school outreach in the Petaling Jaya/Kelana Jaya area. Participants will be allocated using a computer-generated, concealed 1:1:1 sequence with randomly varied permuted blocks of 3 and 6, stratified by child age category and parental education (final age categories to be reconciled). Arm 1 receives a smartphone app with approximately six short interactive modules, stepwise first-aid algorithms, audiovisual content and quizzes, plus a 10-minute orientation and reminders on days 7 and 14. Arm 2 receives access to an AI chatbot restricted to a curated, guideline-based dental-trauma knowledge base, providing interactive responses to parent questions; research staff review logs for safety. Arm 3 receives a roughly 12-page A5 printed dental-trauma first-aid booklet with a standardized two-minute handover and no scheduled reminders. All three resources address common dental injuries using the same core evidence-based guidance. The intervention period is four weeks and follow-up continues to 12 weeks after randomization. Outcomes will be assessed with study-specific knowledge and simulated decision-making instruments, confidence and satisfaction measures, and modality-specific engagement metrics. Outcome assessors and data analysts are intended to be blinded, while participants and educators cannot be masked. Analyses are planned under intention-to-treat principles, using adjusted comparisons at four weeks and mixed-effects models for repeated observations; the final analysis plan will specify multiplicity and missing-data handling.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Bikash Chaurasia, MDS
- 電話番号：+60107801823
- メール：drbikashaiims@gmail.com
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Parent or legal guardian of at least one child aged 2-14 years [VERIFY against study summary of 2-12].
- Able to read and understand Malay or English.
- Has regular access to an internet-enabled smartphone.
- Able and willing to provide written informed consent.
- No previous formal training in first aid, nursing, medicine or dentistry.
Exclusion Criteria:
- Formal healthcare, paramedical, nursing, medical or dental qualifications/training.
- Structured dental-trauma or first-aid education in the preceding 6 months.
- Unable to access or use the smartphone app or chatbot (e.g., no compatible device or internet access).
- Parent of a child with special healthcare needs for whom emergency dental management differs substantially from standard guidance.
- Declines informed consent.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Dental Trauma First-Aid Mobile Application
Parents receive a purpose-built mobile application containing approximately six modules with guideline-based dental trauma recognition and first-aid instruction, videos, diagrams, decision algorithms and quizzes. A trained assistant provides an approximately 10-minute orientation. Participants are encouraged to complete the modules within two weeks and may access the app throughout four weeks, with reminders on days 7 and 14. |
Printed educational material with diagrams and action checklists for dental avulsion, luxation, fractures and soft-tissue injury. Self-reported reading frequency and duration are collected. |
|
実験的：Dental Trauma AI Chatbot
Parents receive a link or QR code to an AI chatbot that answers free-text dental-trauma first-aid questions and offers guided scenarios based on a curated guideline-based knowledge base. Access is on demand throughout the four-week intervention; no minimum session count is required. Research staff review chat logs for safety. |
Printed educational material with diagrams and action checklists for dental avulsion, luxation, fractures and soft-tissue injury. Self-reported reading frequency and duration are collected. |
|
アクティブコンパレータ：Printed Dental Trauma First-Aid Booklet
Parents receive an approximately 12-page A5 printed booklet with the same core dental-trauma first-aid education. A standardized two-minute handover is provided, without scheduled follow-up reminders; booklet use is self-directed over four weeks. |
Printed educational material with diagrams and action checklists for dental avulsion, luxation, fractures and soft-tissue injury. Self-reported reading frequency and duration are collected. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parental Knowledge of Dental Trauma Emergency Management at Week 4
時間枠：Baseline and 4 weeks after randomization (primary comparison at week 4)
|
Measured by the study-specific 20-item Parental Dental Trauma Knowledge Questionnaire (PDTKQ), comprising multiple-choice items based on dental-trauma first-aid guidance. Scores range from 0 to 100; higher scores indicate better knowledge. Primary analysis compares week-4 scores between randomized groups, adjusting for baseline scores. |
Baseline and 4 weeks after randomization (primary comparison at week 4)
|
|
Dental Trauma Emergency Decision-Making Accuracy at Week 4
時間枠：4 weeks after randomization (primary comparison); 12-week results recorded separately as follow-up
|
Measured by a study-specific Dental Trauma Emergency Decision-Making Scenario Test comprising five clinical vignettes addressing avulsion, luxation, crown/root fracture and soft-tissue injury. Scored from 0 to 100 for correctness, completeness and timeliness; higher scores represent more accurate decisions. |
4 weeks after randomization (primary comparison); 12-week results recorded separately as follow-up
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knowledge Retention at Week 12
時間枠：4 and 12 weeks after randomization
|
Change in PDTKQ score from week 4 to week 12 (0-100 scale; positive values indicate increased knowledge). |
4 and 12 weeks after randomization
|
|
Parent Confidence in Dental Emergency Management
時間枠：Baseline, 4 and 12 weeks after randomization
|
Study-specific 10-item confidence scale with responses scored 0-10 per item. Specify sum/mean and exact final range before submission. |
Baseline, 4 and 12 weeks after randomization
|
|
Satisfaction With Assigned Education Resource
時間枠：4 weeks after randomization
|
Study-specific 12-item satisfaction survey administered in all three groups; define scoring and interpretation in the final protocol. |
4 weeks after randomization
|
|
Usability of Digital Education Resource
時間枠：4 weeks after randomization
|
System Usability Scale (SUS) completed in the app and AI chatbot arms only; report standard 0-100 SUS score (higher indicates greater perceived usability). |
4 weeks after randomization
|
|
Engagement With Assigned Educational Resource
時間枠：During the first 4 weeks after randomization
|
For app: sessions, modules completed and time on task; for chatbot: sessions and messages; for print: self-reported reading frequency and time. Modality-specific metrics are not directly equivalent and may require separate outcome records. |
During the first 4 weeks after randomization
|
|
Correct Emergency Response to Tooth Avulsion
時間枠：4 and 12 weeks after randomization
|
Prespecified avulsion-vignette subscore from decision-making scenario test, assessing appropriate immediate management. The scoring range must be specified. Distinguish primary-tooth versus permanent-tooth avulsion in the final wording. |
4 and 12 weeks after randomization
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parent Anxiety About Managing Dental Emergencies
時間枠：Baseline and 4 weeks after randomization
|
Single-item 0-10 numeric rating scale for anxiety, with higher values indicating greater anxiety; clarify exact question text in protocol. |
Baseline and 4 weeks after randomization
|
|
Knowledge Score at Week 12
時間枠：12 weeks after randomization
|
PDTKQ total score 0-100, higher scores indicate better knowledge. |
12 weeks after randomization
|
|
Emergency Decision-Making Accuracy at Week 12
時間枠：12 weeks after randomization
|
Scenario test score 0-100, higher scores indicate better emergency decisions. |
12 weeks after randomization
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Bikash Chaurasia, MDS、Lincoln University College
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- LUC/SOD/2026/18222/CT4
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified participant-level data for primary and secondary outcomes, with selected demographic and baseline variables, may be shared after publication subject to review of a scientifically sound proposal and an executed data-use/confidentiality agreement.
IPD 共有時間枠
From 12 months through 5 years after publication of the main trial results. No sharing before publication.
IPD 共有アクセス基準
Qualified researchers may submit a methodologically sound proposal to the principal investigator. Requests will be reviewed by the principal investigator and primary sponsor and require approval and a signed data-access/confidentiality agreement. Contact: drbikashaiims@gmail.com.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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