Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety

April 15, 2020 updated by: Zohour Ibrahim Mahmoud Rashwan, Alexandria University

Effect of Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety : Implications for Evidence-Based Practice

Aim

This study aimed to determine the effect of virtual reality distraction versus positive pre-visit imagery intervention on children's dental fear and anxiety during local anaesthesia injection.

Research Hypotheses

  1. Children who receive Virtual reality distraction or Positive pre-visit imagery intervention exhibit less dental fear and anxiety levels during LA injection than those who do not.
  2. Children who receive Virtual reality distraction exhibit less dental fear and anxiety levels during LA injection than those who receive Positive pre-visit imagery intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Promoting children's health is a crucial nursing role. Dental health and psychological well-being are basic components of the health promotion for young children. Dental procedures especially local anesthesia injection is one of the most unpleasant experiences for young children. Dental Fear and Anxiety are considered pervasive psychological problems accompanied with strong negative feelings among a large portion of young children. Basically, dental fear and anxiety have been reported as one of the most important reasons for avoidance of dental treatments among young children, thereby results in an adverse effects on their oral and psychological health.

Nurses face a great challenge to minimize dental fear and anxiety and stabilize young children psychologically during restorative dental procedures. Such stabilization is the cornerstone of successful local anaesthesia injection and facilitating dentist's mission.

Virtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. It integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. Virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience.

Positive pre-visit imagery is one of the superior cognitive- behavioral interventions. It is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach. It helps them to anticipate, deal with, and be empowered to gain mastery over the events they will experience. It also plays a role in counteracting the distorted beliefs that invading the children's conscious awareness.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Age ranged from 4- 6 years.
  • Had a previous experience of dental local anaesthesia injection.
  • Had carious mandibular primary molar and planned for restorative dental treatment.

Exclusion Criteria:

  • Age more than 6 years.
  • visual or auditory deficits.
  • chronic or mental disabilities that affect their understanding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual Reality Distraction
Virtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. It integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. Virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience.
Behavioral: Virtual Reality Distraction
The researchers will prepare the VR device. The researches will explain the aim of using VR and adopt tell-show-do technique in introducing VR Glasses. Once VR device headset will be adapted to the child's head size and adjusted in front of his/her eyes, the selected 3D cartoon movie will be played in the waiting room and throughout the procedure of dental LA injection. After ensuring that the child is fully immersed in the cartoon movie, a needle of local anesthetic agent will be prepared and injected after explanation of the procedure.
EXPERIMENTAL: Positive Pre-Visit Imagery Intervention
Positive pre-visit imagery is one of the superior cognitive- behavioral interventions. It is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach
Behavioral: Positive Pre-Visit Imagery Intervention
Short narrative visual information regarding the dental chair, environment and equipment will be provided. It will be done through showing children an interactive book that contained photographs of A4 size, depicting three children model aged 4 - 6 years who are smiling while sitting in the dental chair and cooperative with the dentist. Benefit of LA in alleviating pain will be explained. The researchers also will explore the children's reflection of the children model and allow them ask questions relevant to LA injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Local Anaesthesia Injection Fear Scale
Time Frame: 10 minutes
This was scale developed by the researchers after thorough review of related literature to measure children's dental fear during dental local anaethesia injection (Riba et al., 2017 & Malhotra et al., 2018). It consisted of 15 items that emphasized on observing children's fear behavioral response. The scale comprises of two main categories including avoidant behaviors such as refuses to leave caregiver, sits on the dental chair or opens mouth in addition to over-exaggerated behaviors, such as attempts to dislodge syringe, kicks the doctor and leaves the chair. Each item was measured on a two-points Likert scale ranged from zero "behavior is not present" to one "behavior is present".
10 minutes
Venham's Dental Clinical Anxiety Rating Scale
Time Frame: 10 minutes
This scale was developed by Venham and Kremer (1979) to quantify the anxious behaviors of 4-6 years-old children during situational dental anxiety. It is consisted of 6 items that were rated from relaxed to out of contact and were given numeric digit from zero to five respectively as follows: The scale was reliable and valid and can be easily integrated in clinical or research activities. Its content validity was 0.91 and a test-retest reliability revealed to be 0.93.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 16, 2020

Primary Completion (ANTICIPATED)

April 30, 2020

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (ACTUAL)

April 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2113042020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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