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Recruiting NCT07740525

Evaluation of Audiovisual Aids and Parental Presence for Anxiety Reduction in Pediatric Dental Patients

No phase Interventional Anxiety in Children

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: Audiovisual Aids, Parental Presence.
Who it may be relevant to
Registry conditions: Anxiety in Children. Basic parameters: 4 years — 11 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
Pakistan
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 Behavior Modification Techniques on Anxiety Reduction in Pediatric Patients: Audiovisual Aids and Parental Presence Comparison

Overview

This randomized control trial aims to compare the effectiveness of audiovisual distraction and parental presence in reducing dental anxiety among pediatric patients ongoing treatment. Anxiety will be measured using validated behavioral and physiological measures.

Interventions

  • Behavioral Audiovisual Aids
    Children receive audiovisual distraction for example cartoons during procedure to reduce dental anxiety.
  • Behavioral Parental Presence
    One parent will remain present with the child during procedure for reassurance and reduce anxiety

Primary outcome measures

  • Heart rate [Time frame: At Visit 1: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure At Visit 2: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure]
  • Oxygen Saturation [Time frame: Oxygen Saturation will be measured At Visit 1: before the procedure, during the procedure, and immediately after the procedure. At Visit 2: before the procedure, during the procedure, and immediately after the procedure.]

Eligibility criteria

Inclusion criteria

  • Children aged 4-11 years
  • Requiring restorative treatment
  • ASA I and II

Exclusion criteria

  • Children with special healthcare needs Emergency dental treatment

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Pakistan · 1 center
  • Operative dentistry department,PIMS — Islamabad

Identifiers

NCT: NCT07740525 · F-5-2/2024(ERRC)/26th-PIMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗