Clinical trial NCT06976047: Sensory Distraction Tools on Anxiety Management in Pediatric Dental Patient
Official title: Effectiveness of Visual and Sensory Distraction Tools on Anxiety and Behavior Management in Pediatric Dental Patient
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anaesthesia
Anxiety
Children
Keywords: Behavior Management
Distraction techniques
Pain
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of visual and sensory distraction prior to inferior alveolar nerve block administration in healthy children of both genders, aged 4-6 years.

The main questions it aims to answer are:

* How effective are different visual and sensory distraction techniques in reducing pain and anxiety during inferior alveolar nerve block procedures in young children?
* Which type of distraction technique (visual or sensory) is the most effective? This study will compare children receiving visual and sensory distraction with those receiving no distraction to assess differences in pain perception and anxiety levels during the procedure.

Participants will:

* Undergo a standardized inferior alveolar nerve block procedure.
* Be randomly assigned to one of the following groups: visual distraction, sensory distraction, or control (no distraction).
* Complete simple self-reported pain and anxiety assessments appropriate for their age (such as the Wong-Baker FACES Pain Rating Scale).
* Be evaluated using additional objective measures, including the FLACC scale and heart rate monitoring.

Detailed description: Dental anxiety is considered one of the most common challenges in pediatric dentistry, as it directly affects - and may limit - a child's cooperation during treatment.

Distraction techniques work by diverting the child's attention away from painful or difficult therapeutic procedures and are considered highly important in managing children's behavior within the dental clinic.

Various visual and/or auditory distraction methods can be employed by the dental team when working with pediatric patients. Distraction techniques may be either active (such as allowing the child to play electronic games) or passive (such as listening to music or watching animated movies).

These techniques are considered a valuable alternative to pharmacological preparation for completing dental treatments in children, and many pediatric dentists have adopted them as an effective strategy for managing dental anxiety in young patients.

Despite the availability of numerous behavioral management techniques for addressing dental anxiety, the effectiveness of different distraction methods - whether visual, sensory, or a combination of both - still requires further investigation.

Eligibility criteria: Inclusion Criteria:

1. no previous dental experience.
2. definitely positive or positive ratings of Frank scale.
3. Need of IAN block for any dental treatment.

Exclusion Criteria:

1. previous dental experience
2. systematic or mental disorders.
3. definitely negative or negative ratings of Frankel scale
4. Any contraindication for regional anesthesia

Primary outcomes:
measure: Pain levels
timeFrame: 5 minutes following the inferior alveolar nerve block injection.
measure: Anxiety levels
timeFrame: 1 minute during inferior alveolar nerve block administration
Secondary outcomes:
measure: Pulse rate
timeFrame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: School of Dental Medicine
Study officials:
affiliation: Damascus University
name: Alaa M Snobar, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Damascus University
name: Chaza N Kouchaji, PhD
role: STUDY_CHAIR
References:
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