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Completed

NCT Number: NCT06976047

Sensory Distraction Tools on Anxiety Management in Pediatric Dental Patient

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.

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Key information

Conditions

Anaesthesia Anxiety Anxiety Disorders Children Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine

Damascus, P.O.Box 3062, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • previous dental experience
  • systematic or mental disorders.
  • definitely negative or negative ratings of Frankel scale
  • Any contraindication for regional anesthesia

Treatment and study plan

Tell-Show-Do

Behavioral

The inferior alveolar nerve block will be administered utilizing a combination of the Tell-Show-Do technique and verbal distraction. Initially, the procedure will be explained to the child in simple, age-appropriate language to reduce fear and foster understanding ("Tell"). This will be followed by a demonstration of the materials and sensations involved, using models or non-threatening demonstrations on the child's hand ("Show"). Once the child appears comfortable, the actual administration of the nerve block ("Do") will proceed exactly as explained, maintaining consistency between the explanation and the action. Throughout the process, verbal distraction will be continuously employed, engaging the child in non-procedural conversation, offering positive reinforcement, and using calming, encouraging language.

Visual distraction

Behavioral

The child's attention will be distracted before anesthesia by asking the child to participate in the activity and attempt to catch the light. The dentist, using a thumb sleeve placed on their finger, will perform various hand movements. The light in the thumb sleeve is controlled by pressing a battery that turns the light on and off. The child is instructed to catch the light, creating the illusion of passing it from one hand to the other and eventually "swallowing" it into the oral cavity. Once the child appears comfortable, the actual administration of the nerve block will proceed.

Sensory distraction

Behavioral

During the application of local anesthesia, the child will be provided with a Pop-it toy as a form of sensory distraction. The child will be briefly instructed on how to use the toy, with a simple explanation of the method of play, encouraging active engagement throughout the anesthetic procedure.

Visual and sensory distraction

Behavioral

The child's attention will be distracted before anesthesia by asking the child to participate in the activity and attempt to catch the light. The dentist, using a thumb sleeve placed on their finger, will perform various hand movements. The child is instructed to catch the light, creating the illusion of passing it from one hand to the other and eventually "swallowing" it into the oral cavity. During the application of local anesthesia, the child will be provided with a Pop-it toy as a form of sensory distraction. The child will be briefly instructed on how to use the toy, with a simple explanation of the method of play, encouraging active engagement throughout the anesthetic procedure.

Primary outcomes

  1. Pain levels

    Time frame: 5 minutes following the inferior alveolar nerve block injection.

    Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale: 0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst

  2. Anxiety levels

    Time frame: 1 minute during inferior alveolar nerve block administration

    This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale (0 low anxiety and pain level - 10 high anxiety and pain level).

Secondary outcomes

  1. Pulse rate

    Time frame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug

    Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Effectiveness of Visual and Sensory Distraction Tools on Anxiety and Behavior Management in Pediatric Dental Patient

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Nov 17, 2025

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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