Effect of a Visual Pedagogical Intervention on Anticipatory Dental Anxiety in Children: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Self-Reported Dental Anxiety (MCDASf)
Study Overview
Brief Summary
This study evaluated whether a visual educational intervention could reduce dental anxiety in children. During the COVID-19 pandemic, changes in the dental environment, including the use of personal protective equipment, may have increased anxiety levels in pediatric patients.
A total of 70 children aged 5 to 14 years were randomly assigned to either a study group that received a visual educational introduction to the dental environment or a control group that received standard care. Dental anxiety was assessed using validated scales and pulse rate measurements.
The results showed that children who received the visual educational intervention had lower anxiety levels and reduced physiological stress compared to the control group. The effect was more pronounced in older children, suggesting that age and cognitive development play an important role in the effectiveness of such interventions.
Overall, this simple and non-invasive approach may help reduce dental anxiety in children and improve their experience during dental visits.
Detailed Description
The COVID-19 pandemic introduced significant changes to the dental clinical environment, particularly due to the widespread use of personal protective equipment (PPE), which may increase anxiety in pediatric patients. Dental anxiety is a common and multifactorial condition in children and can negatively affect cooperation, treatment outcomes, and overall oral health. Therefore, effective and non-invasive strategies to reduce anticipatory anxiety are essential in pediatric dentistry.
This randomized controlled clinical trial aimed to evaluate the effectiveness of a structured visual educational intervention in reducing anticipatory dental anxiety and physiological responses in children aged 5 to 14 years undergoing restorative dental treatment. The intervention was specifically designed to familiarize children with the dental environment and the appearance of dental professionals during the COVID-19 pandemic.
Participants were randomly assigned in a 1:1 ratio to either an intervention group or a control group using a computer-generated randomization sequence. Allocation concealment was ensured through the use of sequentially numbered, opaque, sealed envelopes. Due to the nature of the intervention, participant blinding was not feasible. However, outcome assessment was performed by a trained pediatric dentist who was blinded to group allocation.
The visual educational intervention consisted of a structured leaflet developed according to visual pedagogy principles. The material included child-friendly images illustrating dental professionals with and without PPE, common dental instruments, and the dental clinical environment. The aim was to provide anticipatory guidance and reduce uncertainty by presenting information in a simple and age-appropriate format.
Children in the intervention group received the visual educational material in the waiting area prior to treatment and were given time to review it with their parents. The control group received standard clinical care without additional preparatory intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessment was performed by a trained paediatric dentist who was blinded to group allocation. Participants and investigators were not blinded due to the nature of the intervention.
Eligibility Criteria
- Ages
- 5 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 5 to 14 years
- •Requiring restorative dental treatment
- •No systemic disease
- •No mental or physical disabilities
- •Not using medications that could affect anxiety assessment
- •Having previous dental experience (i.e., not first dental visit)
Exclusion Criteria
- •Children attending their first dental visit
- •Children with a documented history of definitely negative or negative behavior (Frankl score 1-2)
- •Participants with incomplete data
- •Participants who withdrew consent at any stage of the study
Arms & Interventions
Visual Educational Intervention Group
Participants received a visual educational leaflet introducing the dental environment and personal protective equipment before treatment.
Intervention: Visual Educational Leaflet (Behavioral)
Control group
Participants received standard clinical care without any additional preparatory intervention before treatment.
Outcomes
Primary Outcomes
Self-Reported Dental Anxiety (MCDASf)
Time Frame: Immediately before dental treatment (pre-treatment assessment)
Dental anxiety was assessed using the faces version of the Modified Child Dental Anxiety Scale (MCDASf). The scale consists of 8 items scored from 1 to 5, with a total score range of 8 to 40. Higher scores indicate greater levels of dental anxiety.
Self-Reported Dental Anxiety (FIS)
Time Frame: Immediately before dental treatment (pre-treatment assessment)
Dental anxiety was assessed using the Facial Image Scale (FIS), which consists of 5 facial expressions scored from 1 (very happy) to 5 (very unhappy). Higher scores indicate greater levels of anxiety.
Secondary Outcomes
- Physiological Anxiety Response (Pulse Rate)(Immediately before dental treatment (pre-treatment assessment))
Investigators
Arzu Pınar Erdem
Prof. Dr.
Istanbul University