Evaluation of Audio-Visual Distraction Technique on Child's Anxiety

Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety, Dental; Fear, Dental
• Intervention / Treatment: Device: Nibiru 3D Virtual Reality Headset

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherif A Zakhary, B.D.S; Phone Number: +2001224579366; Email: Sherif_zakhary@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Audio-Visual Distraction Group; 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.	Device: Nibiru 3D Virtual Reality Headset; 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.
No Intervention: Normal Dental Environment Group; Normal Dental Environment without any distractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Image Scale	To measure dental Anxiety by using Facial Image Scale	Immediately right after the dental visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation (using Pulse oximetry)	to assess the amount of oxygen saturation and relate to the stress level.	During the dental visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate (using Pulse oximetry)	to asses heart beats per minute and relate it to the patient's anxiety	During the dental visit

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mahmoud Hamdy, professor, Cairo University; Study Chair: Nada Wassef, Ass. Prof, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Audio Visual Distraction
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Protocol CairoU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No