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Enrolling by invitation NCT07371442

Effect of AV Distraction and Acuapoint Stimulation in Pediatric Extraction on Pain and Anxiety

No phase Interventional Tooth Extraction Local Anesthesia Anxiety Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acualief, Audiovisual, TELL SHOW DO.
Who it may be relevant to
Registry conditions: Tooth Extraction, Local Anesthesia, Anxiety, Pain. Basic parameters: 5 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of Audiovisual Distraction and Acuapoint Stimulation on Anxiety and Pain Perception During Tooth Extraction in Children: A Randomized Controlled Clinical Study.

Overview

The aim of this study is to evaluate the effectiveness of audiovisual distraction and acuapoint stimulation on anxiety and pain perception during tooth extraction in children.

Interventions

  • Device Acualief
    Aculief acupressure device will be placed on the LI4 Point (figure 1) which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration. The administration of local anesthesia in all groups will be achieved by 1.8 ml of 2% Lidocaine with 1/100,000 epinep
  • Device Audiovisual
    A dental video story will be presented to the patient using an iPad device connected to a noise cancellation headphone.
  • Behavioral TELL SHOW DO
    This group will be treated using Tell-show-do technique

Primary outcome measures

  • Anxiety [Time frame: Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).]
Secondary outcome measures (1)
  • Pain of the patient [Time frame: Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5)]

Eligibility criteria

Inclusion criteria

  • 1- Children with behavior rating score 2,3 according to Frankl's behavior rating scale.

2- Children aged 5-8 years requiring primary tooth extraction. 3- Healthy children free of systemic diseases

Exclusion criteria

  • 1- Children with special health care needs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry Mansoura university — Al Mansurah

Identifiers

NCT: NCT07371442 · A03012024PP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗