Sensory Distraction Tools on Anxiety Management in Pediatric Dental Patient

NCT06976047 | Completed DMC

• 1 other identifier: UDDS-Pedo-1-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthesia; Anxiety; Children

Keywords

Behavior Management; Distraction techniques; Pain

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Pulse rate

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

Study Arms (4)

Tell-Show-Do Technique

OTHER

Evaluation of Tell-Show-Do Technique in the management of anxious pediatric patients during inferior alveolar nerve.

Behavioral: Tell-Show-Do

Visual distraction using magic tricks

EXPERIMENTAL

Evaluation of Visual distraction using magic tricks in the management of anxious pediatric patients during inferior alveolar nerve.

Behavioral: Visual distraction

Sensory distraction using sensory toys

EXPERIMENTAL

Evaluation of Sensory distraction using sensory toys in the management of anxious pediatric patients during inferior alveolar nerve.

Behavioral: Sensory distraction

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.

Behavioral: Visual and sensory distraction

Interventions

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.

Tell-Show-Do Technique

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.

Visual distraction using magic tricks

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.

Sensory distraction using sensory toys

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.

Combining visual distraction using magic tricks with sensory distraction using sensory toys

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

School of Dental Medicine

Damascus, P.O.Box 3062, Syria

Location

Related Publications (5)

• 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.

  PMID: 33735633 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.

  PMID: 36478192 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.

  PMID: 37313267 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.

  PMID: 20361440 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.

  PMID: 36974915 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alaa M Snobar, DDS

  Damascus University

  PRINCIPAL INVESTIGATOR

• Chaza N Kouchaji, PhD

  Damascus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: December 15, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 30, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)