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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07411157
Enrollment
48
Registered
2026-02-13
Start date
2023-07-10
Completion date
2024-02-01
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pain

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

Interventions

BEHAVIORALVirtual 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.

BEHAVIORALWhite 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

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain-related behaviorThe 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

MeasureTime frameDescription
Pulse rateThe 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.
Self reported painThe 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.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORNahla A. Aly, MSc

Alexandria University

STUDY_DIRECTORAmina M. Abdelrahman, PhD

Alexandria University

STUDY_CHAIRKarin ML Dowidar, PhD

Alexandria University

STUDY_DIRECTORTarek Omar, PhD

Alexandria University

STUDY_DIRECTORNourhan M. Aly, PhD

Alexandria University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026