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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Bikash Chaurasia, MDS
- Telefonnummer: +60107801823
- E-Mail: drbikashaiims@gmail.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Parental Knowledge of Dental Trauma Emergency Management at Week 4
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Knowledge Retention at Week 12
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Parent Anxiety About Managing Dental Emergencies
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 weeks after randomization
|
Scenario test score 0-100, higher scores indicate better emergency decisions. |
12 weeks after randomization
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Bikash Chaurasia, MDS, Lincoln University College
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- LUC/SOD/2026/18222/CT4
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
From 12 months through 5 years after publication of the main trial results. No sharing before publication.
IPD-Sharing-Zugriffskriterien
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.
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