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NCT06153823

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

Status unknown NA Last updated 1 December 2023
What this trial tests

NA trial testing virtual reality glasses in Dental Anxiety in 40 participants. Status unknown.

Timeline
1 October 2023
Primary endpoint
1 February 2024
1 March 2024

Quick facts

Lead sponsorHams Hamed Abdelrahman
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date1 October 2023
Primary completion1 February 2024
Estimated completion1 March 2024
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Hams Hamed Abdelrahman — full company profile →

Who can join

Adults 5 to 7, any sex, with Dental Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effectiveness of virtual reality glasses with integrated sign language in reducing dental anxiety during pulpotomy in children with hearing impairment: a randomized controlled trial.
    Salama RM, El-Habashy LM, Zeitoun SI. · · 2024 · cited 2× · PMID 39548423 · DOI 10.1186/s12903-024-05129-1

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