An interventional study of virtual reality glasses and Tell Show and Do in Dental Anxiety, sponsored by Hams Hamed Abdelrahman. Recruiting at 1 site in Egypt. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment
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.
Hams Hamed Abdelrahman is the lead sponsor of 111 studies on the registry; 9 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: virtual reality glasses
Other: Tell Show and Do
child behavior management will be done by using VR glasses distraction
child behavior management will be done by using tell show and do technique
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.
Time frame: up to 2 months
Change in heart rate
Heart rate (HR) is a physiological sign of pain. It will be measured using a pulse oximeter
Time frame: up to 2 months
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
Time frame: up to 2 months
Started Oct 2023 (actual). Primary completion is estimated for Feb 2024, 4 months after the start.
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