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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Bikash Chaurasia, MDS
- Номер телефона: +60107801823
- Электронная почта: drbikashaiims@gmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Экспериментальный: 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. |
|
Активный компаратор: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Parental Knowledge of Dental Trauma Emergency Management at Week 4
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Knowledge Retention at Week 12
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Parent Anxiety About Managing Dental Emergencies
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 12 weeks after randomization
|
Scenario test score 0-100, higher scores indicate better emergency decisions. |
12 weeks after randomization
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Bikash Chaurasia, MDS, Lincoln University College
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- LUC/SOD/2026/18222/CT4
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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.
Сроки обмена IPD
From 12 months through 5 years after publication of the main trial results. No sharing before publication.
Критерии совместного доступа к IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
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