Sensory Distraction Tools on Anxiety Management in Pediatric Dental Patient

NCT ID: NCT06976047

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-07-30

Brief Summary

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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:

* 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

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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.

Conditions

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Anaesthesia Anxiety Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tell-Show-Do Technique

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

Group Type OTHER

Tell-Show-Do

Intervention Type 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 using magic tricks

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

Group Type EXPERIMENTAL

Visual distraction

Intervention Type 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 using sensory toys

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

Group Type EXPERIMENTAL

Sensory distraction

Intervention Type 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.

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

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.

Group Type EXPERIMENTAL

Visual and sensory distraction

Intervention Type 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.

Interventions

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Tell-Show-Do

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.

Intervention Type BEHAVIORAL

Visual distraction

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.

Intervention Type BEHAVIORAL

Sensory distraction

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.

Intervention Type BEHAVIORAL

Visual and sensory distraction

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alaa M Snobar, DDS

Role: PRINCIPAL_INVESTIGATOR

Damascus University

Chaza N Kouchaji, PhD

Role: STUDY_CHAIR

Damascus University

Locations

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School of Dental Medicine

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 36478192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33735633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37313267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20361440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36974915 (View on PubMed)

Other Identifiers

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UDDS-Pedo-1-2025

Identifier Type: -

Identifier Source: org_study_id

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