- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07571421
Effect of a Visual Educational Intervention on Dental Anxiety in Children
Effect of a Visual Pedagogical Intervention on Anticipatory Dental Anxiety in Children: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Dental anxiety was assessed using validated self-report measures, including the faces version of the Modified Child Dental Anxiety Scale (MCDASf) and the Facial Image Scale (FIS). In addition, physiological response to anxiety was evaluated by measuring pulse rate using a pulse oximeter. All outcome assessments were performed prior to the initiation of dental treatment.
To explore potential differences in intervention effectiveness, subgroup analyses were conducted based on age groups (5-7, 8-10, and 11-14 years) and sex. These groupings were selected to reflect differences in cognitive development, which may influence how children process and respond to visual information.
This study provides insight into the potential role of visual educational strategies as a simple, low-cost, and non-invasive method to reduce anticipatory dental anxiety in pediatric patients, particularly in the context of altered clinical environments such as those observed during the COVID-19 pandemic.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 34188
- Istanbul University Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Visual Educational Intervention Group
Participants received a visual educational leaflet introducing the dental environment and personal protective equipment before treatment.
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A structured visual educational leaflet designed to familiarise children with the dental clinical environment and personal protective equipment.
The material included child-friendly images of dental staff, equipment, and procedures to reduce anticipatory dental anxiety.
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No Intervention: Control group
Participants received standard clinical care without any additional preparatory intervention before treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Reported Dental Anxiety (MCDASf)
Time Frame: Immediately before dental treatment (pre-treatment assessment)
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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.
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Immediately before dental treatment (pre-treatment assessment)
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Self-Reported Dental Anxiety (FIS)
Time Frame: Immediately before dental treatment (pre-treatment assessment)
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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.
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Immediately before dental treatment (pre-treatment assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological Anxiety Response (Pulse Rate)
Time Frame: Immediately before dental treatment (pre-treatment assessment)
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Physiological response to dental anxiety was assessed by measuring pulse rate (beats per minute, bpm) using a pulse oximeter device.
Higher values indicate greater physiological arousal associated with anxiety.
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Immediately before dental treatment (pre-treatment assessment)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Arzu P Erdem, Principle Investigator, Istanbul University Faculty of Dentistry
Publications and helpful links
General Publications
- Cirio S, Salerno C, Mbanefo S, Oberti L, Paniura L, Campus G, Cagetti MG. Use of Visual Pedagogy to Help Children with ASDs Facing the First Dental Examination: A Randomized Controlled Trial. Children (Basel). 2022 May 16;9(5):729. doi: 10.3390/children9050729.
- Dogan MC, Seydaoglu G, Uguz S, Inanc BY. The effect of age, gender and socio-economic factors on perceived dental anxiety determined by a modified scale in children. Oral Health Prev Dent. 2006;4(4):235-41.
- Giri S, Saha S, Dhinsa K, Yadav G, Sharma A, Pradhan S. Comparative Evaluation of Behavioral and Physiological Outcomes on Dental Anxiety of Children Undergoing Dental Treatment: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2025 Apr;18(4):383-393. doi: 10.5005/jp-journals-10005-3088. Epub 2025 May 19.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUFD-2021/53
- TLO-2021-38364 (Other Grant/Funding Number: Research Fund of Istanbul University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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