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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tell-Show-Do Technique | Other | Evaluation of Tell-Show-Do Technique in the management of anxious pediatric patients during inferior alveolar nerve. |
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| Visual distraction using magic tricks | Experimental | Evaluation of Visual distraction using magic tricks in the management of anxious pediatric patients during inferior alveolar nerve. |
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| Sensory distraction using sensory toys | Experimental | Evaluation of Sensory distraction using sensory toys in the management of anxious pediatric patients during inferior alveolar nerve. |
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| Combining visual distraction using magic tricks with sensory distraction using sensory toys | Experimental | Evaluation of combining visual distraction using magic tricks with sensory distraction using sensory toys in the management of anxious pediatric patients during inferior alveolar nerve. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain levels | 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 | 5 minutes following the inferior alveolar nerve block injection. |
| Anxiety levels | 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). | 1 minute during inferior alveolar nerve block administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse rate | Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter. | (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alaa M Snobar, DDS | Damascus University | Principal Investigator |
| Chaza N Kouchaji, PhD | Damascus University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine | Damascus | P.O.Box 3062 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33735633 | Background | Su HC, Hsieh CW, Lai NM, Chou PY, Lin PH, Chen KH. Using Vibrating and Cold Device for Pain Relieves in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Pediatr Nurs. 2021 Nov-Dec;61:23-33. doi: 10.1016/j.pedn.2021.02.027. Epub 2021 Mar 16. | |
| 36478192 | Background | Alsibai E, Bshara N, Alzoubi H, Alsabek L. Assessing an active distracting technique during primary mandibular molar pulpotomy (randomized controlled trial). Clin Exp Dent Res. 2023 Apr;9(2):283-289. doi: 10.1002/cre2.702. Epub 2022 Dec 8. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
|
| 37313267 | Background | Kothari P, Mathur A, Chauhan RS, Nankar M, Tirupathi S, Suvarna A. Effectiveness of thaumaturgic distraction in alleviation of anxiety in 4-6-year-old children during inferior alveolar nerve block administration: a randomized controlled trial. J Dent Anesth Pain Med. 2023 Jun;23(3):143-151. doi: 10.17245/jdapm.2023.23.3.143. Epub 2023 May 26. |
| 20361440 | Background | Hart R, Walton M. Magic as a therapeutic intervention to promote coping in hospitalized pediatric patients. Pediatr Nurs. 2010 Jan-Feb;36(1):11-6; quiz 17. |
| 36974915 | Background | Bawaeda O, Wanda D, Aprillia Z. Effectiveness of pop-it therapeutic play on children's anxiety during inhalation therapy in children's wards. Pediatr Med Chir. 2023 Mar 28;45(s1). doi: 10.4081/pmc.2023.315. |
| 42344791 | Derived | Snobar AM, Kouchaji CN, Al-Shiekh MN. Effectiveness of Thumb Sleeve Distraction and Pop-It Therapeutic Play in Reducing Dental Anxiety and Pain in Children Aged 4-6 Years Undergoing Mandibular Alveolar Nerve Block: A Randomized Controlled Trial. Int J Dent. 2026 Jun 23;2026:9319639. doi: 10.1155/ijod/9319639. eCollection 2026. |