The Effectiveness of Audiovisual Distraction Behavior Guidance Technique in Children With Dental Anxiety

NCT04226651 | Completed

• 1 other identifier: DIS-217
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, two-armed, placebo-controlled, cross-over, controlled trial aimed to evaluate the effect of virtual reality exposure therapy (VRET) on dental anxiety, pain, and behaviour among children undergoing dental treatment under local anaesthesia. The null hypotheses were as follows: VRET has no effect on reducing dental anxiety and dental pain scores of participants; and there is no difference between subjective and objective measure scores of dental anxiety and pain when VRET and attention palcebo-controlled (APC) groups are used to reduce anxiety in children undergoing dental treatment with local anaesthesia.

Conditions

Dental Anxiety; Dental Pain and Sensation Disorder

Outcome Measures

Primary Outcomes (2)

• Dental Anxiety

  Dental anxiety will be assessed using the Heart Rate with a portable pulse oximetry device

  Time 0: a minute after sitting in the dental unit ; Time 1: 1 min before local anaesthesia; Time 2: 1 min after local anaesthesia; Time 3: 1 min before end of the treatment

• Dental Anxiety

  Dental anxiety was assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) and Facial Image Scale (FIS)

  Visit 0: 5 min before first inclusion visit, Visit 1: 5 min before first dental treatment visit,Visit 2: 5 min before second dental treatment visit,

Secondary Outcomes (3)

• Dental Pain

  Time 0: a minute after sitting in the dental unit ; Time 1: 1 min before local anaesthesia; Time 2: 1 min after local anaesthesia; Time 3: 1 min before end of the treatment

• Dental Pain

  Time 2: 1 min after local anaesthesia; Time 3: 1 min before end of the treatment

• Dental behavior

  Time 3: 1 min before end of the treatment

Study Arms (2)

First dental visit

ACTIVE COMPARATOR

Virtual Reality Exposure Therapy

Device: Virtual Reality Device

Second Dental Visit

PLACEBO COMPARATOR

Protective Glasses

Device: Protective glasses

Interventions

Virtual Reality Device DEVICE

The Virtual Reality system (PlayStation 4 VR, Sony Inc.) is a simple and easy to use distraction device. The system consists of a screen mounted on a binocular headset connected to a console or personal computer. The head-mounted display provides a high-resolution visual display and unmutes the sound from the headphones using a soundproof mechanism that provides clear sound.

First dental visit

Protective glasses DEVICE

Each patient was informed about the dental procedure and was provided with protective glasses. All patients were told that they were wearing these glasses to ensure a pain- and stress-free treatment, and that the dentist would devote additional attention to the treatment.

Second Dental Visit

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Requiring restorative treatment for first mandibular permanent molar tooth with dentin caries in each mandibular quadrant with a bilateral inferior alveolar nerve block
• Co-operative ability

You may not qualify if:

• Systemic or mental illnesses
• Limited audiovisual capabilities
• Acute dental pain or trauma

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Burak Buldur

Sivas, Kampus, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Toothache; Sensation Disorders

Interventions

Eye Protective Devices

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Model Details: randomized, two-armed, within-subject, cross-over, controlled

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: March 11, 2019
• Primary Completion: June 18, 2019
• Study Completion: September 16, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)