Effect of AI-Supported Child-Friendly Communication on Dental Anxiety in Pediatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorÇanakkale Onsekiz Mart University
About this trial
This study compares the effects of traditional behavior management techniques and AI-assisted child-friendly communication on dental anxiety, physiological stress, and pain perception during local anesthesia in healthy children aged 6-12. The aim is to evaluate the effectiveness of AI-supported communication tools in reducing anxiety and improving comfort in pediatric dental treatments, potentially enhancing clinical outcomes and advancing technology use in pediatric dentistry.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children volunteers and their parents/legal guardians who have read and signed the informed consent form and agreed to participate in the study
Systemically healthy children aged 6-12 years in the mixed dentition period
Children requiring restorative dental procedures (including pulpotomy, pulp capping, or composite restorations) on mandibular teeth under inferior alveolar nerve block local anesthesia
Children who are attending their first dental visit and demonstrate behavior rated as 2 (negative) or 3 (positive) according to the Frankl Behavior Rating Scale (Categories: 1 - definitely negative; 2 - negative; 3 - positive; 4 - definitely positive) Behaviors will be categorized as positive (+) or negative (-) based on the Frankl Behavior Rating Scale (Wright's modification)
Disqualifiers
Children volunteers and their parents/legal guardians who read the informed consent form but declined to participate in the study
Children with systemic diseases requiring continuous medication
Children with mental or cognitive impairments, as well as those with visual or hearing disabilities
Children who, after oral prophylaxis at the first visit, exhibit "definitely negative" (Frankl 1) or "definitely positive" (Frankl 4) behavior according to the Frankl Behavior Rating Scale
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Assisted Child-Friendly Communication
BehavioralAI-assisted communication tailored to the developmental stage, age, and gender of children aged 7-12 will be used. Using ChatGPT, voice recordings explaining the local anesthesia process in a child-friendly and reassuring way-avoiding anxiety-provoking terms such as "pain" and "needle"-will be prepared. Additionally, a one-minute calming and distracting story will be generated to be played during anesthesia to reduce anxiety and improve cooperation. Children will listen to the AI-generated explanation before the procedure and the story during anesthesia.
Traditional Behavior Management Techniques
BehavioralBefore local anesthesia, traditional behavior management techniques will be applied by the pediatric dentist based on clinical experience. These include a modified Tell-Show-Do approach (avoiding direct exposure to anxiety-provoking items like dental syringes), voice control, and positive reinforcement. The anesthesia procedure will be explained verbally in an age-appropriate and reassuring manner, for example by describing the use of a "magic sleepy spray" to numb the tooth. Following this, topical anesthesia and then local anesthesia will be administered. The total procedure will not exceed 5 minutes.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Traditional Behavior Management (Control Group)Other 1 intervention
Group B: Arm 2: AI-Assisted Child-Friendly CommunicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pulse
Throughout the session, pulse levels were recorded using a pulse oximeter at three points: before, during, and after the local anesthesia.
Time frame
5 minutes2
Oxygen Saturation
Throughout the session, saturation levels were recorded using a pulse oximeter at three points: before, during, and after the local anesthesia.
Time frame
5 minutesSecondary outcomes
1
Change in Facial Image Scale (FIS)" score
FIS assesses anxiety in children using five facial expressions ranging from very happy to very unhappy. Children select the face that best represents their feelings at that moment. Scores range from 1 to 5; higher scores indicate higher anxiety levels.
Time frame
Within 5 minutes before local anesthesia administration, and within 5 minutes after completion of local anesthesia procedure.2
Wong-Baker Faces Pain Rating Scale
This visual self-report tool uses six faces to represent increasing levels of pain. Children choose the face that best matches their pain level. Scores range from 0 (no pain) to 10 (worst pain).
Time frame
within 5 minutes after completion of local anesthesia procedure.3
Modified Houpt Behavior Rating Scale score
This scale evaluates movement, crying, and overall behavior during treatment, each rated from 1 to 4. Higher total scores indicate lower cooperation and increased treatment difficulty.
Time frame
During treatment4
Frankl Behavior Rating Scale
This 4-point behavioral rating scale assesses cooperation during dental treatment. Scores: 1 (definitely negative), 2 (negative), 3 (positive), 4 (definitely positive). Higher scores reflect more cooperative behavior.
Time frame
During treatmentOther outcomes
1
Perceptions and attitudes of children and parents toward AI-assisted communication
This outcome measure evaluates the perceptions and attitudes of pediatric patients and their parents regarding AI-assisted communication used prior to dental treatment. Child questionnaire: A 4-item scale with 5-point Likert responses ("Strongly agree" to "Strongly disagree"). The items assess how the child felt after communicating with the AI before treatment, whether dental stories from the AI helped make treatment easier, whether the child would tell peers about the experience, and whether they would have allowed treatment without AI communication. Parent questionnaire: A 2-item scale using the same Likert format. Items assess whether AI-assisted communication helped their child cope with dental anxiety and whether they would recommend such use to others.
Time frame
within 5 minutes after completion of local anesthesia procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov