Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110379
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Nourhan M.Aly, University of Alexandria

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

Condition or disease Intervention/treatment Phase
Dental Anxiety Behavioral: Virtual Reality (VR) Behavioral: Conventional Behavior Management Techniques Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment(Randomized Controlled Clinical Trial)
Actual Study Start Date : July 20, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Reality (VR)
Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd))
Behavioral: Virtual Reality (VR)
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.

Active Comparator: Conventional Behavior Management
Child behavior management will be done using conventional behavior management techniques
Behavioral: Conventional Behavior Management Techniques
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 Measures :
  1. Preoperative Venham clinical anxiety rating scale [ Time Frame: Baseline; at the beginning of the visit ]
    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

  2. Postoperative Venham clinical anxiety rating scale [ Time Frame: post dental treatment; after 2 hours ]
    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

  3. Preoperative evaluation of salivary cortisol level [ Time Frame: Baseline; at the beginning of the visit ]
    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.

  4. Postoperative evaluation of salivary cortisol level [ Time Frame: post dental treatment; after 2 hours ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110379


Contacts
Layout table for location contacts
Contact: Yomna Alaa Eldin, BDS 01061431319 ext +20 yomna-alaa@hotmail.com
Contact: Nourhan M Aly, BDS 01006639489 ext +2 nourhan.moustafa@alexu.edu.eg

Locations
Layout table for location information
Egypt
Faculty of Dentistry, Alexandria University Recruiting
Alexandria, Egypt, 21512
Contact: Nourhan M Aly, BDS    (03) 4868308    dent-dean@alexu.edu.eg   
Sponsors and Collaborators
Nourhan M.Aly
Alexandria University
Investigators
Layout table for investigator information
Principal Investigator: Yomna Alaa Eldin, BDS Faculty of Dentistry, Alexandria University, Egypt
Study Director: Karin M.L. Dowidar, PhD Faculty of Dentistry, Alexandria University, Egypt
Study Director: Laila El Habashy, PhD Faculty of Dentistry, Alexandria University, Egypt
Study Director: Akram Deghady, PhD Faculty of Medicine, Alexandria University, Egypt
Publications:
Layout table for additonal information
Responsible Party: Nourhan M.Aly, Instructor of Dental Public Health, University of Alexandria
ClinicalTrials.gov Identifier: NCT04110379    
Other Study ID Numbers: VR for anxiety
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nourhan M.Aly, University of Alexandria:
virtual reality
distraction
salivary cortisol
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders