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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153823
• Other study ID #: 0665-04/2023
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: Alexandria University
• Contact: Reem MS Shehata, BDS
• Phone: 01223172660
• Email: r.shehata.dent.pg[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Deafness
• Dental Anxiety
• Hearing Loss

Intervention

Other:
• virtual reality glasses
child behavior management will be done by using VR glasses distraction
• Tell Show and Do
child behavior management will be done by using tell show and do technique

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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