AnaesthesiaNCT06976047
Sensory Distraction Tools on Anxiety Management in Pediatric Dental Patient
A study testing Tell-Show-Do, Visual distraction and Sensory distraction in people with Anaesthesia and Anxiety, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaesthesia, Anxiety, Children
- What is being tested?
- Tell-Show-Do, Visual distraction and Sensory distraction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSyria
- Study dates
- 15 Dec 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no previous dental experience.
- definitely positive or positive ratings of Frank scale.
- Need of IAN block for any dental treatment.
Who cannot join
- previous dental experience
- systematic or mental disorders.
- definitely negative or negative ratings of Frankel scale
- Any contraindication for regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Visual and Sensory Distraction Tools on Anxiety and Behavior 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:
Read more
- 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.
Read the 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.
- Conditions
- Anaesthesia, Anxiety, Children
- Being tested
- Tell-Show-Do, Visual distraction, Sensory distraction, Visual and sensory distraction
- Keywords
- Behavior Management, Distraction techniques, Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tell-Show-DoBehavioural
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 distractionBehavioural
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 distractionBehavioural
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 distractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tell-Show-Do Technique | Other | Evaluation of Tell-Show-Do Technique in the management of anxious pediatric patients during inferior alveolar nerve. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Visual and sensory distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 1 minute during inferior alveolar nerve block administration
Secondary outcomes (1)
Pulse rate
Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.
Measured: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 Dec 2024
- Primary completion22 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa M Snobar, DDS, Principal investigator, Damascus UniversityChaza N Kouchaji, PhD, Study chair, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976047
- Sponsor's protocol ID
- UDDS-Pedo-1-2025
- Status last verified
- Nov 2025
- First submitted
- 9 May 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33735633Alsibai 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.
PubMed 36478192Kothari 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.
PubMed 37313267Hart 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.
PubMed 20361440Bawaeda 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.
PubMed 36974915Snobar 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.
PubMed 42344791
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Visual and Sensory Distraction Tools on Anxiety and Behavior Management in Pediatric Dental Patient
- ClinicalTrials.gov ID
- NCT06976047
- Acronym / sponsor ID
- UDDS-Pedo-1-2025
- Conditions
- Anaesthesia, Anxiety, Children
- Keywords
- Behavior Management, Distraction techniques, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tell-Show-Do Technique | Other | Behavioral: Tell-Show-DoEvaluation of Tell-Show-Do Technique in the management of anxious pediatric patients during inferior alveolar nerve. |
| Visual distraction using magic tricks | Experimental | Behavioral: Visual distractionEvaluation of Visual distraction using magic tricks in the management of anxious pediatric patients during inferior alveolar nerve. |
| Sensory distraction using sensory toys | Experimental | Behavioral: Sensory distractionEvaluation of Sensory distraction using sensory toys in the management of anxious pediatric patients during inferior alveolar nerve. |
| Combining visual distraction using magic tricks with sensory distraction using sensory toys | Experimental | Behavioral: Visual and sensory distractionEvaluation of combining visual distraction using magic tricks with sensory distraction using sensory toys in the management of anxious pediatric patients during inferior alveolar nerve. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- no previous dental experience.
- definitely positive or positive ratings of Frank scale.
- Need of IAN block for any dental treatment.
Key exclusion criteria (4 listed)
- previous dental experience
- systematic or mental disorders.
- definitely negative or negative ratings of Frankel scale
- Any contraindication for regional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tell-Show-DoThe 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. | Behavioural | Tell-Show-Do Technique |
| Visual distractionThe 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. | Behavioural | Visual distraction using magic tricks |
| Sensory distractionDuring 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. | Behavioural | Sensory distraction using sensory toys |
| Visual and sensory distractionThe 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. | Behavioural | Combining visual distraction using magic tricks with sensory distraction using sensory toys |
Primary outcome
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
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 33735633Su 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.
- Background: PubMed 36478192Alsibai 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.
- Background: PubMed 37313267Kothari 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.
- Background: PubMed 20361440Hart 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.
- Background: PubMed 36974915Bawaeda 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.
- Derived from this study: PubMed 42344791Snobar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa M Snobar, DDS principal investigator
Damascus University
Chaza N Kouchaji, PhD study chair
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tell-Show-Do, Visual distraction and Sensory distraction in people with Anaesthesia and Anxiety, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels (time frame: 5 minutes following the inferior alveolar nerve block injection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06976047, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.