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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety, Dental focused on measuring Audio Visual Distraction

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 23, 2017
    Last Updated
    July 24, 2017
    Sponsor
    Cairo University
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    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

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