Influence of Parental Smartphone Use on Child Behavior and Heart Rate During Local Anesthesia (para-apical injection) in Pediatric Dentistry: A Randomized Controlled Trial

Description :

Prospective parallel-group RCT (1:1). Children 4–7 years requiring para-apical injection for maxillary primary molars will be enrolled. This age band is targeted because cooperation and caregiver–child attachment are highly influential in this period and have been specifically studied in dental settings among 4–7-year-olds (25), making outcomes developmentally meaningful and comparable to prior work. Participants will be randomized to two groups: Group 1, parents using a smartphone (no interaction during the injection) versus Group 2, attentive parent (no smartphone; supportive attention). Primary outcome: Frankl behavior scores immediately after the injection. Secondary outcome: heart-rate trajectory across baseline, measured by a pulse Oximeter (BPL Smart Oxy): o Fingertip pulse oximeter with perfusion index o Clinical accuracy, visual alarm, low-battery indicator o Powered by 2×AAA (1.5V) batteries o Manufacturer: BPL Medical Technologies Pvt Ltd (ISO 13485:2016 certified) Measures will be taken at three points: (60 s seated after topical anesthesia, before needle uncapping) → injection → first 60 s post-injection. Operator, anesthetic, and monitoring protocols will be standardized; injections will be delivered with a computer-controlled electronic syringe (low-flow mode) to minimize bias, and the outcome assessor will be blinded to group assignment.

Titulaire :
ABOU CHEDID Jean-Claude

Contact USJ :
jeanclaude.abouchedid@usj.edu.lb

Chercheur(s) :
Dr Jean-Claude ABOU CHEDID
Veronique Azar

Projet présenté au CR, le : 01/05/2026

Projet achevé auprès du CR : 01/02/2027