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Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment

Primary Purpose

Dental Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Virtual Reality (VR)
Conventional Behavior Management Techniques
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Anxiety focused on measuring virtual reality, distraction, salivary cortisol

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy children (ASA category I).
  • Frankl behavior rating score 2 or 3.
  • Requiring pulpotomy in one of their primary molars.

Exclusion Criteria:

  • Children taking medications that interfere with measures of salivary cortisol.
  • Presence of any systemic or mental disease.

Sites / Locations

  • Faculty of Dentistry, Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality (VR)

Conventional Behavior Management

Arm Description

Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd))

Child behavior management will be done using conventional behavior management techniques

Outcomes

Primary Outcome Measures

Preoperative Venham clinical anxiety rating scale
This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact
Postoperative Venham clinical anxiety rating scale
This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact
Preoperative evaluation of salivary cortisol level
Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit.
Postoperative evaluation of salivary cortisol level
Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2019
Last Updated
August 19, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04110379
Brief Title
Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment
Official Title
Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment(Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) to conventional behavior management techniques as a distraction method on child's dental anxiety during dental treatment
Detailed Description
The study to be conducted will be a randomized controlled clinical trial .The sample will consist of forty children presented to the Department of Pediatric Dentistry and Dental Public Health, 20 preschoolers of age ranging from 4-5 years old and 20 schoolers of age ranging from 6-8 years old. The eligible participants will be randomly divided into a study group where virtual reality glasses distraction will be used for child behavior management and a control group where conventional behavior management techniques (tell-show-do, distraction, and positive reinforcement) will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
virtual reality, distraction, salivary cortisol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The eligible participants will be randomly and equally divided into group I (study) and group II (control). Each group will be further subdivided according to age into subgroup A (preschool aged children) and subgroup B (school aged children).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality (VR)
Arm Type
Experimental
Arm Description
Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd))
Arm Title
Conventional Behavior Management
Arm Type
Active Comparator
Arm Description
Child behavior management will be done using conventional behavior management techniques
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality (VR)
Intervention Description
All the dental procedures that will be done will be explained to the child using tell-show-do technique. VR glasses will be introduced to the child using tell-show-do technique and he will be given a choice of cartoon episodes to select from according to his own interest and age appropriate to view during the dental treatment. The child will be given five minutes to get familiar with the VR glasses before starting the dental treatment.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Behavior Management Techniques
Intervention Description
Conventional behavior management techniques will be done to relieve the child's dental anxiety during the dental treatment such as : tell-show-do technique, distraction, and positive reinforcement, according to the child's behavior.
Primary Outcome Measure Information:
Title
Preoperative Venham clinical anxiety rating scale
Description
This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact
Time Frame
Baseline; at the beginning of the visit
Title
Postoperative Venham clinical anxiety rating scale
Description
This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact
Time Frame
post dental treatment; after 2 hours
Title
Preoperative evaluation of salivary cortisol level
Description
Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit.
Time Frame
Baseline; at the beginning of the visit
Title
Postoperative evaluation of salivary cortisol level
Description
Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit.
Time Frame
post dental treatment; after 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy children (ASA category I). Frankl behavior rating score 2 or 3. Requiring pulpotomy in one of their primary molars. Exclusion Criteria: Children taking medications that interfere with measures of salivary cortisol. Presence of any systemic or mental disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yomna Alaa Eldin, BDS
Phone
01061431319
Ext
+20
Email
yomna-alaa@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nourhan M Aly, BDS
Phone
01006639489
Ext
+2
Email
nourhan.moustafa@alexu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna Alaa Eldin, BDS
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karin M.L. Dowidar, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laila El Habashy, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Akram Deghady, PhD
Organizational Affiliation
Faculty of Medicine, Alexandria University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nourhan M Aly, BDS
Phone
(03) 4868308
Email
dent-dean@alexu.edu.eg

12. IPD Sharing Statement

Citations:
PubMed Identifier
27409593
Citation
Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.
Results Reference
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PubMed Identifier
27022303
Citation
Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016.
Results Reference
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PubMed Identifier
23277857
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.
Results Reference
background
PubMed Identifier
26929683
Citation
Fakhruddin KS, Hisham EB, Gorduysus MO. Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent. 2015 Oct-Dec;9(4):470-475. doi: 10.4103/1305-7456.172637.
Results Reference
background
PubMed Identifier
29670727
Citation
Gadicherla S, Shenoy RP, Patel B, Ray M, Naik B, Pentapati KC. Estimation of salivary cortisol among subjects undergoing dental extraction. J Clin Exp Dent. 2018 Feb 1;10(2):e116-e119. doi: 10.4317/jced.54369. eCollection 2018 Feb.
Results Reference
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Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment

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