Effect of AI-Supported Child-Friendly Communication on Dental Anxiety in Pediatric Patients
NCT ID: NCT07133919
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-10-15
2026-01-31
Brief Summary
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Detailed Description
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The integration of artificial intelligence (AI) and digital technologies has enabled personalized communication strategies adapted to children's cognitive and psychosocial development. AI tools such as ChatGPT act as distraction methods to reduce anxiety and stress during dental procedures. Furthermore, AI-enhanced audiovisual devices like virtual reality (VR) headsets have been shown to decrease dental anxiety, physiological stress responses, and pain perception in pediatric patients.
This study will be conducted with healthy children aged 7 to 12 who require inferior alveolar nerve block (IANB) anesthesia and have Frankl Behavior Rating Scale scores of 2 (negative) or 3 (positive). Demographic and dental data such as age, gender, and treated tooth numbers will be recorded prior to the procedure.
Participants will be randomly assigned into two groups: Group 1 (Control) and Group 2 (ChatGPT).
Control Group (Group 1):
Before local anesthesia, traditional behavior management techniques selected by the pediatric dentist based on clinical observation and experience will be applied. These include modified Tell-Show-Do (limiting exposure to potentially anxiety-provoking stimuli like dental syringes), voice control, and positive reinforcement. Explanations regarding the anesthesia procedure will be delivered verbally, tailored to the child's cognitive level and understanding capacity.
For example (From the investigators to participants):
"Hello, welcome! I see you are a bit worried, but that's very normal. People sometimes get scared of things they don't know, right? Now, please lie back comfortably, and I will tell you what are we (investigators) going to do. First, I will spray a magic sleepy water (or cold spray/warm water) on your (participants')tooth. This will make your tooth numb, so you won't feel anything. You might feel a tiny little mosquito touch, but it will pass quickly. Then your tooth will be asleep, and we (investigators) will do our work comfortably. While I'm making your tooth sleep, just lean back and think of happy memories." Following this, traditional behavior management techniques such as positive reinforcement and voice control will accompany the topical anesthesia application and then the local anesthesia procedure. The total procedure duration will not exceed 5 minutes.
Experimental Group (Group 2):
Given that cognitive abilities, language comprehension, and psychosocial needs vary by developmental stage, AI-supported communication content will be structured accordingly. Using ChatGPT, age- and gender-specific voice recordings explaining the local anesthesia procedure will be created considering developmental characteristics of children aged 7-12. Additionally, a one-minute child-friendly, anxiety-reducing story without anxiety-provoking words will be generated to be played during the anesthesia application to enhance patient cooperation and reduce anxiety.
Commands given to the AI were:
"I am about to apply local anesthesia to a \[age\]-year-old \[girl/boy\] patient with high anxiety levels. Please explain the procedure steps in a child-friendly, simple, and reassuring manner avoiding words like 'pain' and 'needle', considering developmental characteristics, age-appropriate interests, and gender-specific tendencies."
"During the anesthesia application, please tell a one-minute calming and distracting story suitable for a \[age\]-year-old \[girl/boy\], without anxiety-provoking expressions, tailored to their developmental stage and interests." Before anesthesia, children in this group will listen to the AI-generated voice explanation, and during anesthesia, the AI-generated story will be played.
Assessment criteria:
Physiological responses including heart rate and oxygen saturation will be objectively measured using a pulse oximeter (LifeNet Fingertip Pulse Oximeter; Model: KE-6004) attached to the finger before, during, and after anesthesia, recording the highest values for each phase. Subjective anxiety will be evaluated with the Venham Picture Test (VPT) and Facial Image Scale (FIS) before and after anesthesia. Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale at the end of anesthesia. Dental anxiety will be evaluated before and after anesthesia using the Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f). Children's behavior during anesthesia will be recorded using the Modified Houpt Behavior Scale based on the clinician's observations. Cooperation levels will be assessed with the Frankl Behavior Rating Scale before and after anesthesia. Finally, to evaluate perceptions and attitudes toward AI-assisted communication, a 4-item child questionnaire and a 2-item parent questionnaire using 5-point Likert scales will be administered after treatment.
This study aims to compare the effectiveness of traditional behavior management techniques versus AI-assisted child-friendly communication in managing dental anxiety, physiological stress, and pain perception during local anesthesia in children, potentially contributing to innovative, evidence-based approaches in pediatric dental care.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Traditional Behavior Management (Control Group)
Traditional Behavior Management Techniques
Before 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.
Arm 2: AI-Assisted Child-Friendly Communication
AI-Assisted Child-Friendly Communication
AI-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.
Interventions
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AI-Assisted Child-Friendly Communication
AI-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
Before 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.
Eligibility Criteria
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Inclusion Criteria
* 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)
* Children receiving local anesthesia for the first time
Exclusion Criteria
* 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
* Children with previous experience of local anesthesia
7 Years
12 Years
ALL
Yes
Sponsors
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Çanakkale Onsekiz Mart University
OTHER
Responsible Party
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Burak Carıkcıoglu
Associate Professor
Locations
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Canakkale Onsekiz Mart University
Çanakkale, Kepez, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Faculty of Dentistry
Role: primary
Other Identifiers
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CanakkaleOMU2
Identifier Type: -
Identifier Source: org_study_id