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Enrolling by Invitation

NCT Number: NCT07371442

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

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.

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Mansoura university

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acualief

Device

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 epinephrine using a 30-gauge long needle

Audiovisual

Device

A dental video story will be presented to the patient using an iPad device connected to a noise cancellation headphone.

TELL SHOW DO

Behavioral

This group will be treated using Tell-show-do technique

Primary outcomes

  1. 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).

    Anxiety will be measured by A) Pulse oximeter: Pulse oximeter was used to observe the physiological functions like heart rate and SpO₂.

    B) Venham's picture test: the child was presented with eight different cards. Each card held two pictures-a representation of the child expressing anxiety along with another representation of the same child in a relaxed mood. The child was asked to point out the picture in each pair that resembled how he/she was feeling. There was also an order in which the pictures had to be presented. Assigning the image depicting anxiety the score of 1 and the relaxed image the score of 0 helped in the coding process.

Secondary outcomes

  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)

    will be evaluated by Wong baker FACES pain scale which is consist of six faces numbered ordinary from 0 to 5. ranging from a no pain (score 0) to one showing severe pain (score 5)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: AV Acupoint

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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