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

NCT07411157 | Completed

• 1 other identifier: 9205200
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pulse rate

  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

  The scale was administered at the baseline (preoperative) and postoperatively at the end of the visit.

Study Arms (3)

Virtual reality glasses

EXPERIMENTAL

Behavioral: Virtual reality glasses

White noise

ACTIVE COMPARATOR

Behavioral: White noise

Basic behavior management techniques

SHAM COMPARATOR

Behavioral: Basic behavior management techniques

Interventions

Virtual reality glasses BEHAVIORAL

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.

Virtual reality glasses

White noise BEHAVIORAL

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

White noise

Basic behavior management techniques BEHAVIORAL

Children allocated to this group were managed by the basic behavior guidance techniques: (Tell-ShowDo). No adjunctive distraction tool were used.

Basic behavior management techniques

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt

Alexandria, Alexandria Governorate, 21527, Egypt

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nahla A. Aly, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Amina M. Abdelrahman, PhD

  Alexandria University

  STUDY DIRECTOR

• Karin ML Dowidar, PhD

  Alexandria University

  STUDY CHAIR

• Tarek Omar, PhD

  Alexandria University

  STUDY DIRECTOR

• Nourhan M. Aly, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatric Dentistry

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 13, 2026
• Study Start: July 10, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)