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

NCT ID: NCT03229720

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-09-01

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:

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.

Conditions

Anxiety, Dental; Fear, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nibiru 3D Virtual Reality Headset

Intervention Type: 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.

Normal Dental Environment Group

Normal Dental Environment without any distractions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Adel Khalaf Zakhary

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Hamdy, Professor

Role: STUDY_DIRECTOR

Cairo University

Nada Wassef, Ass. Prof

Role: STUDY_CHAIR

Cairo University

Central Contacts

Sherif A Zakhary, B.D.S

Role: CONTACT

Sherif_zakhary@hotmail.com

+2001224579366

Other Identifiers

Protocol CairoU

Identifier Type: -

Identifier Source: org_study_id