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

NCT04348903 | Unknown

• 1 other identifier: 2113042020
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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. 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. 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.

Conditions

Nurse's Role

Keywords

Virtual Reality; Positive Pre-visit Imagery; Dental Fear; Dental anxiety

Outcome Measures

Primary Outcomes (2)

• Dental Local Anaesthesia Injection Fear Scale

  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

  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

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

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

Positive Pre-Visit Imagery Intervention

EXPERIMENTAL

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

Interventions

Virtual Reality Distraction BEHAVIORAL

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.

Virtual Reality Distraction

Positive Pre-Visit Imagery Intervention BEHAVIORAL

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.

Positive Pre-Visit Imagery Intervention

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Related Publications (7)

• 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.

  PMID: 28879250 BACKGROUND

• 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.

  PMID: 23277857 BACKGROUND

• Fox C, Newton JT. A controlled trial of the impact of exposure to positive images of dentistry on anticipatory dental fear in children. Community Dent Oral Epidemiol. 2006 Dec;34(6):455-9. doi: 10.1111/j.1600-0528.2006.00303.x.

  PMID: 17092274 BACKGROUND

• 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.

  PMID: 25709297 BACKGROUND

• 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.

  PMID: 21806903 BACKGROUND

• 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.

  PMID: 30131642 BACKGROUND

• 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.

  PMID: 399677 BACKGROUND

Central Study Contacts

Zohour I Rashwan, PhD

CONTACT

35094573; zohour.rashwan@alex-nursing.edu.eg

Rasha S Eweida, PhD

CONTACT

01286640701; rashapsych@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 16, 2020
• Study Start: April 16, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 1, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share