Clinical trial NCT04348903: Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nurse's Role
Keywords: Virtual Reality
Positive Pre-visit Imagery
Dental Fear
Dental anxiety
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dental Local Anaesthesia Injection Fear Scale
timeFrame: 10 minutes
measure: Venham's Dental Clinical Anxiety Rating Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Addicks SH, McNeil DW, Randall CL, Goddard A, Romito LM, Sirbu C, Kaushal G, Metzger A, Weaver BD. Dental Care-Related Fear and Anxiety: Distress Tolerance as a Possible Mechanism. JDR Clin Trans Res. 2017 Jul;2(3):304-311. doi: 10.1177/2380084417691962. Epub 2017 Feb 9.
citation: Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
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citation: Gangwal RR, Rameshchandra Badjatia S, Harish Dave B. Effect of Exposure to Positive Images of Dentistry on Dental Anxiety among 7 to 12 Years Old Children. Int J Clin Pediatr Dent. 2014 Sep-Dec;7(3):176-9. doi: 10.5005/jp-journals-10005-1260. Epub 2015 Feb 9.
citation: Ramos-Jorge ML, Ramos-Jorge J, Vieira de Andrade RG, Marques LS. Impact of exposure to positive images on dental anxiety among children: a controlled trial. Eur Arch Paediatr Dent. 2011 Aug;12(4):195-9. doi: 10.1007/BF03262806.
citation: Malhotra R, Gandhi K, Kumar D, Ahuja S, Kapoor R, Sahni A. A Comparative Study to evaluate Parent's Ability to assess Dental Fear in their 6- to 10-year-old Children using Children's Fear Survey Schedule-Dental Subscale. Int J Clin Pediatr Dent. 2018 May-Jun;11(3):205-209. doi: 10.5005/jp-journals-10005-1512. Epub 2018 Jun 1.
citation: Venham LL, Gaulin-Kremer E. A self-report measure of situational anxiety for young children. Pediatr Dent. 1979 Jun;1(2):91-6. No abstract available.