Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure

Effectiveness of Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure (Randomized Controlled Clinical Trial)

To evaluate the impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment.

The study will be a randomized controlled parallel two arms clinical trial, a total of 40 healthy children aged 5-7 years with moderate to severe hearing disability, will be selected from Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Alexandria University, Egypt. Children selected should have at least one primary molar indicated for pulpotomy. The eligible participants will be randomly assigned to one of two groups: the study group, which will use virtual reality glasses with sign language as a distraction method to manage children's behavior, and the control group, which will use the conventional behavior management strategies including show-tell-do, and positive reinforcement. Local anesthesia will be given and pulpotomy procedure will be done on the selected tooth followed by stainless steel crown restoration. Pre and post-operative assessment of child's dental anxiety will be done using three methods: physiologically using pulse oximeter for measuring the heart rate, objectively using Venham clinical anxiety rating scale, and subjectively using the modified facial image scale.

Study Overview

• Status: Recruiting
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: virtual reality glasses; Other: Tell Show and Do

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reem MS Shehata, BDS; Phone Number: 01223172660; Email: r.shehata.dent.pg@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria Faculty of Dentistry
    • Contact: Reem MS Shehata, MS; Email: r.shehata.dent.pg@alexu.edu.eg
    • Principal Investigator: Reem MS Shehata, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children with Frankl behavior rating score 2 or 3.
• Children requiring pulpotomy in one of their primary molars.
• Parents who accepted to give their consent and participate in the study.

Exclusion Criteria:

• Children with any medical condition other than hearing disability (ASA II, III & IV).
• Syndromic children with hearing impairment.
• Children with previous bad dental experience.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality glasses	Other: virtual reality glasses; child behavior management will be done by using VR glasses distraction
Active Comparator: show-tell-do technique.	Other: Tell Show and Do; child behavior management will be done by using tell show and do technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child anxiety level	This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.	up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Heart rate (HR) is a physiological sign of pain. It will be measured using a pulse oximeter	up to 2 months
Change in child anxiety level by subjective method	A modified face scale will be used to subjectively record anxiety . It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively	up to 2 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Anxiety Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 0665-04/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No