Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure
NCT ID: NCT06153823
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-10-01
2024-03-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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virtual reality glasses
virtual reality glasses
child behavior management will be done by using VR glasses distraction
show-tell-do technique.
Tell Show and Do
child behavior management will be done by using tell show and do technique
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Children requiring pulpotomy in one of their primary molars.
* Parents who accepted to give their consent and participate in the study.
Exclusion Criteria
* Syndromic children with hearing impairment.
* Children with previous bad dental experience.
5 Years
7 Years
ALL
No
Sponsors
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Hams Hamed Abdelrahman
OTHER
Responsible Party
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Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Locations
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Alexandria Faculty of Dentistry
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Reem MS Shehata, MS
Role: primary
References
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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.
Other Identifiers
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0665-04/2023
Identifier Type: -
Identifier Source: org_study_id