Technology-based Distraction Techniques in Managing Children With Attention-deficit/Hyperactivity Disorder

Effectiveness of Technology-based Distraction Techniques on Pain Perception of Children With Attention-deficit Hyperactivity Disorder During Different Dental Procedures: A Randomized Controlled Clinical Trial

The present study aims to assess and compare the effectiveness of different technology-based distraction techniques on pain perception and dental anxiety in children with Attention Deficit/Hyperactivity Disorder during different dental procedures

Study Overview

• Status: Completed
• Conditions: Dental Pain
• Intervention / Treatment: Behavioral: Virtual reality glasses; Behavioral: White noise; Behavioral: Basic behavior management techniques

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21527
      • Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist.
• All children should be on stimulant medication.
• No previous dental experience.
• Written consent of the legal guardian.

Exclusion Criteria:

• Children with physical disabilities or other psychiatric disorders.
• Children with visual or hearing disabilities.
• Patients requiring emergency treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: White noise	Behavioral: White noise; Wireless kids' headphones were introduced to the children allocated to this group. They were given some time to accommodate with the headphones. Then, the white noise was played and children were asked to concentrate on the music during the procedure. White noise stimulus was set at 70decibels, within the "normal conversation" volume range and below what is considered harmful to hearing. The white noise of rain sound, managed with an iPhone application called Muse. The decibel level of white noise was calibrated using a portable digital sound level meter
Sham Comparator: Basic behavior management techniques	Behavioral: Basic behavior management techniques; Children allocated to this group were managed by the basic behavior guidance techniques: (Tell-ShowDo). No adjunctive distraction tool were used.
Experimental: Virtual reality glasses	Behavioral: Virtual reality glasses; Children allocated to this group were distracted using VR glasses during dental treatment which is an individual headset that has earphones incorporated. Age-appropriate cartoons and movies were shown to the children. The VR glasses were then introduced to the children. The children were given time to accommodate with the device before starting the procedure. The VR glasses were applied during the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-related behavior	Children's behavior using the revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC). The r-FLACC scale has been identified as a recommended measurement tool for assessing pain in children aged 0 to 18 years, with a high level of intra- and inter-reliability. Each of the r-FLACC's categories is scored from 0 to 2, which results in a total score between 0 and 10: 0 'relaxed and comfortable'; 1-3 'mild discomfort'; 4-6 'moderate pain'; and 7-10 'severe pain or discomfort or both. The operator assigned a score to each child based on the child's behavior by analysis of the recorded videotape.	The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse rate	The pulse rate was measured using a pulse oximeter. Normal range is considered from 70-110.	The pulse rate was recorded at the baseline and perioperative during needle penetration, rubber dam clamp application, caries removal, placement of composite restoration, and postoperatively after composite finishing and occlusal adjustment.
Self reported pain	Self-reported pain was measured using the Wong-Baker FACES rating scale using six cartoon faces, from a broad smile (0, "No Hurt") to a tearful frown (10, "Hurts Worst"), to help children indicate their pain level, with scores increasing by twos (0, 2, 4, 6, 8, 10) to represent mild to severe pain.	The scale was administered at the baseline (preoperative) and postoperatively at the end of the visit.

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: Karin ML Dowidar, PhD, Alexandria University; Principal Investigator: Nahla A. Aly, MSc, Alexandria University; Study Director: Amina M. Abdelrahman, PhD, Alexandria University; Study Director: Tarek Omar, PhD, Alexandria University; Study Director: Nourhan M. Aly, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Toothache
• Other Study ID Numbers: 9205200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No