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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pain-related behavior
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 10 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Virtual reality glasses
Intervention: Virtual reality glasses (Behavioral)
White noise
Intervention: White noise (Behavioral)
Basic behavior management techniques
Intervention: Basic behavior management techniques (Behavioral)
Outcomes
Primary Outcomes
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
- 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.)
Investigators
Nahla Aly
Assistant Lecturer of Pediatric Dentistry
Alexandria University