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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.
Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Heart Rate
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Time frame: baseline
Heart Rate
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Time frame: after 5 minutes
Oxygen saturation
Oxygen saturation will be monitored using an oximeter
Time frame: baseline
Oxygen saturation
Oxygen saturation will be monitored using an oximeter
Time frame: after 5 minutes
Behavior Evaluation
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Time frame: baseline
Behavior Evaluation
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Time frame: after 1 week during follow-up sessions
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