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Completed

NCT Number: NCT07411157

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

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

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Key information

Conditions

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

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Alexandria Governorate, 21527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Pain-related behavior

    Time frame: The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.

    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.

Secondary outcomes

  1. Pulse rate

    Time frame: 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.

    The pulse rate was measured using a pulse oximeter. Normal range is considered from 70-110.

  2. Self reported pain

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

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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