Anxiety
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERESPeRATE™
Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.
BEHAVIORALTell, Show and Do technique
Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).
Sponsors
Alexandria University
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The operator will not be blinded to the treatment as the RESPeRATE™ will be used for the study group while the device will not be applied to the control group.
Intervention model description
The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Normal healthy children (physical status ASA I & II). * Scoring 26 or more on faces version of modified child dental anxiety scale (MCDASf). * Dental procedure requiring local anesthesia. * Completion of a parental consent to participate in the study.
Exclusion criteria
* Children on anxiolytic medication or using any medication directly related to emotional or cognitive function. * Children with special needs. * Children on medications that specifically agonize or antagonize alpha- or beta-adrenergic processes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation | baseline | Oxygen saturation will be monitored using an oximeter |
| Heart Rate | baseline | A finger pulse oximeter will be placed on the finger of the left hand of the child. |
| Behavior Evaluation | baseline | using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive |
Countries
Egypt
Outcome results
None listed