NCT07371442

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 11, 2026

Last Update Submit

January 19, 2026

Conditions

Keywords

AudiovisualacuapointacupressureTSDpainanxietytooth extraction

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    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.

    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 Outcomes (1)

  • Pain of the patient

    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)

Study Arms (3)

dental story

EXPERIMENTAL

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

Device: Audiovisual

Aculief

EXPERIMENTAL

Aculief acupressure device will be placed on the LI4 Point 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. to patients

Device: Acualief

TSD

EXPERIMENTAL

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

Behavioral: TELL SHOW DO

Interventions

AcualiefDEVICE

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

Aculief

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

dental story
TELL SHOW DOBEHAVIORAL

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

TSD

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with behavior rating score 2,3 according to Frankl's behavior rating scale.
  • Children aged 5-8 years requiring primary tooth extraction. 3- Healthy children free of systemic diseases

You may not qualify if:

  • Children with special health care needs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Mansoura university

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2026

First Posted

January 28, 2026

Study Start

February 2, 2025

Primary Completion

July 15, 2025

Study Completion

February 15, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations