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

Sponsor
Alexandria University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04348903
Collaborator
(none)
90
2
15

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Distraction
  • Behavioral: Positive Pre-Visit Imagery Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effect of Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety : Implications for Evidence-Based Practice
Anticipated Study Start Date :
Apr 16, 2020
Anticipated Primary Completion Date :
Apr 30, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Dental Local Anaesthesia Injection Fear Scale [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".

  2. Venham's Dental Clinical Anxiety Rating Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zohour Ibrahim Mahmoud Rashwan, lecturer, Alexandria University
ClinicalTrials.gov Identifier:
NCT04348903
Other Study ID Numbers:
  • 2113042020
First Posted:
Apr 16, 2020
Last Update Posted:
Apr 16, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zohour Ibrahim Mahmoud Rashwan, lecturer, Alexandria University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 16, 2020