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Completed

NCT Number: NCT07571421

Effect of a Visual Educational Intervention on Dental Anxiety in Children

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.

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Key information

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Faculty of Dentistry

Istanbul, 34188, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual Educational Leaflet

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. Physiological Anxiety Response (Pulse Rate)

    Time frame: Immediately before dental treatment (pre-treatment assessment)

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effect of a Visual Pedagogical Intervention on Anticipatory Dental Anxiety in Children: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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