Virtual Reality Distraction and Dental Anxiety Among Anxious Pediatric Patients

NCT05663619 | Completed

• 1 other identifier: KAUFD20221207
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study evaluated the effect of Virtual Reality Distraction (VRD) on dental anxiety among anxious children undergoing prophylactic dental treatment by utilizing both subjective (Venham Anxiety and Behavioral Rating Scale (VABRS)) and objective (heart rate (HR) and salivary cortisol level (SCL)) measures. Method and Materials: This randomized controlled study included 36 6- to 14-year-old healthy and anxious children who needed prophylactic dental treatment and who had a history of previous dental treatment. The eligible children's anxiety level was evaluated using a modified version of Abeer Dental Anxiety Scale-Arabic version (M-ACDAS) and those who scored at least 14 or more out of 21 were included. Participants were randomly distributed to either the VRD or control group. In the VRD group, participants wore the VRD device during prophylactic dental treatment. In the control group, subjects received their treatment while watching a video cartoon on a regular screen. The participants were videotaped during the treatment and their HR was recorded at four time points. Also, a sample from each participant's saliva was collected twice, at the baseline and after the procedure.

Conditions

Children's Dental Anxiety

Keywords

Dental anxiety; heart rate; salivary cortisol; virtual reality

Outcome Measures

Primary Outcomes (3)

• Change in Heart rate

  The HR was recorded using a pulse oximeter

  (1) as a baseline in the waiting area before dental treatment; (2) in the dental chair immediately before starting the procedure; (3) during prophylactic dental treatment procedure; (4) immediately after the procedure was completed

• Venham Anxiety and Behavioral Rating Scale

  During the treatment, participants were videotaped using a high-resolution camera. Later, two trained and calibrated evaluators assessed the participant's anxiety using the Venham Anxiety and Behavioral Rating Scale independently. The scale consists of five defined behavioral categories ranging from zero to five. A higher score indicates a greater level of anxiety.

  1 day (during dental treatment procedure)

• Change in Salivary cortisol levels.

  Two saliva samples were collected from each participant: (1) as a baseline in the waiting area; (2) after the dental procedure was completed. Approximately two mL of saliva was collected using Salivettes®, and the samples were stored at -20oC until evaluation. To minimize the effects of the diurnal cortisol cycle, all study procedures and saliva sample collection were performed between 10:00 am and 2:00 pm. The cortisol levels were measured using the Cortisol Saliva Enzyme-Linked Immunosorbent Assay (ELISA) Assay Kit (ab 154996- cortisol ELISA kit, Abcam, UK) following the manufacturer's instructions.

  (1) as a baseline in the waiting area before dental treatment; (2) immediately after the dental procedure was completed

Study Arms (2)

Virtual Reality distraction (VRD)

EXPERIMENTAL

In the VRD group, participants wore a VRD device and watched a previously selected favorite cartoon during the prophylactic dental treatment.

Device: Virtual Reality Distraction during dental treatment of children.

control group

ACTIVE COMPARATOR

In the control group, participants received their treatment while watching a previously selected favorite cartoon on a regular screen.

Other: Control: watching cartoon on screen as distraction during dental treatment of children.

Interventions

Virtual Reality Distraction during dental treatment of children. DEVICE

One of the behavior management techniques used with children in dental clinics to allow for delivering quality dental treatment is the use of Virtual Reality distraction (VRD). Virtual reality distraction immerses the patient in an environment generated by a computer and works by simulating as many senses as possible: vision, hearing, and touch. In dentistry, VRD has exhibited great results in reducing anxiety and fear among children and adolescents compared to those who received no intervention or more conventional BMTs. VRD may allow the dentist to provide more efficient dental treatments, ranging from simple anesthesia to more advanced forms of dental treatment

Virtual Reality distraction (VRD)

Control: watching cartoon on screen as distraction during dental treatment of children. OTHER

The American Academy of Pediatric Dentistry (AAPD) recommends a series of non-pharmacological behavior management techniques for managing children during dental care including distraction. Distraction is defined by AAPD as "the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure". It is widely used as it provides an effective and relaxing experience during treatment.

control group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 14-year-old.
• Healthy.
• With a history of previous dental treatment.
• High dental anxiety (high score on a modified version of Abeer Children Dental Anxiety Scale (M-ACDAS)).

You may not qualify if:

• Visual or auditory deficits.
• History of epilepsy, and/or anxiety disorder.
• Non-Arabic speaking children.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, 80209, Saudi Arabia

Location

Related Publications (3)

• Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.

  PMID: 34172032 BACKGROUND

• Shetty V, Suresh LR, Hegde AM. Effect of Virtual Reality Distraction on Pain and Anxiety During Dental Treatment in 5 to 8 Year Old Children. J Clin Pediatr Dent. 2019;43(2):97-102. doi: 10.17796/1053-4625-43.2.5. Epub 2019 Feb 7.

  PMID: 30730798 BACKGROUND

• Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694.

  PMID: 32440065 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pediatric Dentistry

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 23, 2022
• Study Start: October 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)