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

NCT06153823 | Unknown

• 1 other identifier: 0665-04/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in heart rate

  up to 2 months

• Change in child anxiety level by subjective method

  up to 2 months

Study Arms (2)

virtual reality glasses

EXPERIMENTAL

Other: virtual reality glasses

show-tell-do technique.

ACTIVE COMPARATOR

Other: Tell Show and Do

Interventions

virtual reality glasses OTHER

child behavior management will be done by using VR glasses distraction

virtual reality glasses

Tell Show and Do OTHER

child behavior management will be done by using tell show and do technique

show-tell-do technique.

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

Related Publications (1)

• Salama RM, El-Habashy LM, Zeitoun SI. Effectiveness of virtual reality glasses with integrated sign language in reducing dental anxiety during pulpotomy in children with hearing impairment: a randomized controlled trial. BMC Oral Health. 2024 Nov 15;24(1):1388. doi: 10.1186/s12903-024-05129-1.

  PMID: 39548423 DERIVED

Central Study Contacts

Reem MS Shehata, BDS

CONTACT

01223172660; r.shehata.dent.pg@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: December 1, 2023
• Study Start: October 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

EG (1)