Clinical trial NCT03229720: Evaluation of Audio-Visual Distraction Technique on Child's Anxiety
Official title: Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety, Dental
Fear, Dental
Keywords: Audio Visual Distraction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients.

This study is designed to compare between conventional dental visits (No Distraction) and dental visits aided with audio-visual distraction. Providing a safe, comfortable and entertaining dental environment will give pediatric children a better perception regarding the dental environment and motivate them for repetitive dental visits for better dental health care.

Detailed description: \[I\] Recruitment: Children aged 5\~8 years old with teeth decay requiring restorative dental treatment will be randomly selected according to the Intrusion and Extrusion Criteria.

\[II\] Intervention:

-Steps:

1. The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.
2. The visit will be started by using the tell-show-do technique to explain the procedure. After that the Facial Image Scale is validated to assess dental anxiety and will be explained to the child. The dentist will ask the child to choose one of the six faces that best represented his/her current emotional state.
3. Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.
4. Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.
5. Above steps will be done in both visits, with and without the intervention.
6. If the toss had AV-distraction, The operator will introduce the Audio-visual device (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient to choose his favorite show to watch during the dental visit.
7. The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.
8. The operator will apply topical and dental anaesthesia
9. Pulse rate will be measured every 5 minutes.
10. The operator will allow extra time if the dental visit ended before the child finishes the tv-show.
11. Then operator will ask the patient to choose from the face scale diagrams about his anxiety state at the end of the visit.

Intervention modifications:

In case the child interrupted the dental visit for questions or any reason, the last record of pulse oximeter will be repeated.

Eligibility criteria: Inclusion Criteria:

* Children aged 5-8 years old.
* Children with decayed teeth requiring pulp therapy (excluding cases with acute pulpitis)
* Cooperative children and potentially cooperative
* Physically and mentally normal children.
* No previous dental experience involving local anaesthetic administration for the last 2 years

Exclusion Criteria:

* Children with visual impairment.
* Children with hearing disabilities.
* Children with disability complicating the dental treatment as trismus, or TMJ problems.
* Children with highly inflamed pulp tissue inducing pain during dental visit.
* Patients or caregivers who refuse to sign the consent.

Primary outcomes:
measure: Facial Image Scale
timeFrame: Immediately right after the dental visit.
Secondary outcomes:
measure: Oxygen Saturation (using Pulse oximetry)
timeFrame: During the dental visit
Other outcomes:
measure: Heart Rate (using Pulse oximetry)
timeFrame: During the dental visit
Locations:
Study officials:
affiliation: Cairo University
name: Mahmoud Hamdy, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Nada Wassef, Ass. Prof
role: STUDY_CHAIR
References: