NCT07722221

Brief Summary

Studying the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2023

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 12, 2026

Last Update Submit

July 18, 2026

Conditions

Keywords

Dental extractionVirtual realityLocal anesthesia

Outcome Measures

Primary Outcomes (2)

  • Pain level during dental anesthesia and treatment

    Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain. Higher scores on either scale indicated greater pain intensity.

    From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.

  • Anxiety level during anesthesia and treatment

    Anxiety was assessed using the Venham Picture Test (VPT), a self-reported measure of dental anxiety in children. The scale consists of 8 pairs of drawings, with the child selecting the picture that best reflects their feelings at each pair. Scores range from 0 to 8, where 0 indicates no anxiety and 8 indicates the highest level of anxiety. Higher scores indicate greater anxiety.

    From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.

Secondary Outcomes (4)

  • Pulse rate

    From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.]

  • Oxygen saturation

    From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.

  • Blood pressure

    From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.

  • Patient's satisfaction

    Immediately after the procedure

Study Arms (2)

Control

ACTIVE COMPARATOR

Behaviour management was done using the conventional techniques during Local anaesthesia and extraction

Device: Conventional

Virtual Reality

EXPERIMENTAL

Behaviour management was done using virtual reality technique during Local anaesthesia and extraction.

Device: Virtual reality

Interventions

Behaviour management was done using Virtual Reality technique during Local anaesthesia and treatment (extraction)

Virtual Reality

Behaviour management was done using the conventional techniques (TSD, positive reinforcement) during Local anaesthesia and treatment (extraction)

Control

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-10 years.
  • Physically healthy with no neurological disorders or systemic diseases.
  • Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
  • Not taking any sedatives or analgesics drugs

You may not qualify if:

  • Uncooperative children who exhibit clear behavioral problems.
  • Children with systemic diseases or disorders that may interfere with local anesthesia.
  • Use of any medications that may affect vital signs or pain response.
  • Presence of infection at the injection site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Dentistry ,Tishreen University, Latakia, Syria

Latakia, Syria

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 23, 2026

Study Start

May 1, 2021

Primary Completion

December 13, 2022

Study Completion

March 12, 2023

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations