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

NCT03229720 | Unknown DMC

• 1 other identifier: Protocol CairoU
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety, Dental; Fear, Dental

Keywords

Audio Visual Distraction

Outcome Measures

Primary Outcomes (1)

• Facial Image Scale

  To measure dental Anxiety by using Facial Image Scale

  Immediately right after the dental visit.

Secondary Outcomes (1)

• Oxygen Saturation (using Pulse oximetry)

  During the dental visit

Other Outcomes (1)

• Heart Rate (using Pulse oximetry)

  During the dental visit

Study Arms (2)

Audio-Visual Distraction Group

ACTIVE COMPARATOR

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

Normal Dental Environment Group

NO INTERVENTION

Normal Dental Environment without any distractions.

Interventions

Nibiru 3D Virtual Reality Headset DEVICE

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.

Audio-Visual Distraction Group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mahmoud Hamdy, Professor

  Cairo University

  STUDY DIRECTOR

• Nada Wassef, Ass. Prof

  Cairo University

  STUDY CHAIR

Central Study Contacts

Sherif A Zakhary, B.D.S

CONTACT

+2001224579366; Sherif_zakhary@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician is blinded by naming the groupes into group A and group B .
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 25, 2017
• Study Start: September 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 25, 2017

Record last verified: 2017-07