Anxiety Clinical Trial
Official title:
The Effect of a Respiratory Biofeedback Device on Reduction of Dental Anxiety Associated With Local Anesthesia in Children: A Randomized Controlled Clinical Trial
The aim of the study was to investigate the effect of a respiratory biofeedback device (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia.
The study was a randomized controlled clinical trial. A total of 110 anxious pediatric dental
patients, of age range 7-12 years, were selected from the Pediatric Dentistry and Dental
Public Health Department, Faculty of Dentistry, Alexandria University, Egypt, after securing
parental informed consents. Children were chosen according to the Faces version of Modified
Child Dental Anxiety Scale scoring 26 or more.
The participants will be randomly allocated into 2 groups: Group I: Study group and Group II:
Control group. The patients of group I (Study group) will undergo a session of biofeedback
regulation by using "RESPeRATETM" as an anxiety reducing method. Group II patients will be
managed by a routine behavioral management technique "Tell,show,do". Local anesthesia
injection will be administered to the child, after which heart rate measurement and salivary
sample for salivary amylase analysis will be repeated.
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