Evaluation of Audio-Visual Distraction Technique on Child's Anxiety
Primary Purpose
Anxiety, Dental, Fear, Dental
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nibiru 3D Virtual Reality Headset
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety, Dental focused on measuring Audio Visual Distraction
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Audio-Visual Distraction Group
Normal Dental Environment Group
Arm Description
In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group.
Normal Dental Environment without any distractions.
Outcomes
Primary Outcome Measures
Facial Image Scale
To measure dental Anxiety by using Facial Image Scale
Secondary Outcome Measures
Oxygen Saturation (using Pulse oximetry)
to assess the amount of oxygen saturation and relate to the stress level.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03229720
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.
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.
Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.
Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.
Above steps will be done in both visits, with and without the intervention.
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.
The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.
The operator will apply topical and dental anaesthesia
Pulse rate will be measured every 5 minutes.
The operator will allow extra time if the dental visit ended before the child finishes the tv-show.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Dental, Fear, Dental
Keywords
Audio Visual Distraction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The statistician is blinded by naming the groupes into group A and group B
.
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Audio-Visual Distraction Group
Arm Type
Active Comparator
Arm Description
In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group.
Arm Title
Normal Dental Environment Group
Arm Type
No Intervention
Arm Description
Normal Dental Environment without any distractions.
Intervention Type
Device
Intervention Name(s)
Nibiru 3D Virtual Reality Headset
Intervention Description
This device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings.
Primary Outcome Measure Information:
Title
Facial Image Scale
Description
To measure dental Anxiety by using Facial Image Scale
Time Frame
Immediately right after the dental visit.
Secondary Outcome Measure Information:
Title
Oxygen Saturation (using Pulse oximetry)
Description
to assess the amount of oxygen saturation and relate to the stress level.
Time Frame
During the dental visit
Other Pre-specified Outcome Measures:
Title
Heart Rate (using Pulse oximetry)
Description
to asses heart beats per minute and relate it to the patient's anxiety
Time Frame
During the dental visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif A Zakhary, B.D.S
Phone
+2001224579366
Email
Sherif_zakhary@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Hamdy, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nada Wassef, Ass. Prof
Organizational Affiliation
Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Audio-Visual Distraction Technique on Child's Anxiety
We'll reach out to this number within 24 hrs