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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06153823
Enrollment
40
Registered
2023-12-01
Start date
2023-10-01
Completion date
2024-03-01
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

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.

Interventions

OTHERvirtual reality glasses

child behavior management will be done by using VR glasses distraction

OTHERTell Show and Do

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

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in child anxiety levelup to 2 monthsThis 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.

Secondary

MeasureTime frameDescription
Change in heart rateup to 2 monthsHeart rate (HR) is a physiological sign of pain. It will be measured using a pulse oximeter
Change in child anxiety level by subjective methodup to 2 monthsA 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

Countries

Egypt

Contacts

Primary ContactReem MS Shehata, BDS
r.shehata.dent.pg@alexu.edu.eg01223172660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026