Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-09 @ 2:14 PM
Study NCT ID:
NCT03229720
Status:
UNKNOWN
Last Update Posted:
2017-07-25
First Post:
2017-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Audio-Visual Distraction Technique on Child's Anxiety
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
\[II\] 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: