Respiratory Biofeedback Device and Reduction of Dental Anxiety Associated With Local Anesthesia in Children

Study Overview
=================
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.

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

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Device: RESPeRATE™
* Behavioral: Tell, Show and Do technique


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RESPeRATE™<br>RESPeRATE™: 2breathe Tech. Ltd., Eshtaol, Israel. The device includes a belt-type respiration sensor worn outside of the clothing that is placed around the torso. It is connected to a computerized box that generates musical patterns listened through an earbud. The device guides the user interactively to slow breathing with a relatively prolonged expiration. | Device: RESPeRATE™<br>* Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.<br>|
| Active Comparator: Tell, Show and Do technique<br> | Behavioral: Tell, Show and Do technique<br>* Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | A finger pulse oximeter will be placed on the finger of the left hand of the child. | baseline | 
| Heart Rate | A finger pulse oximeter will be placed on the finger of the left hand of the child. | after 5 minutes | 
| Oxygen saturation | Oxygen saturation will be monitored using an oximeter | baseline | 
| Oxygen saturation | Oxygen saturation will be monitored using an oximeter | after 5 minutes | 
| Behavior Evaluation | using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive | baseline | 
| Behavior Evaluation | using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive | after 1 week during follow-up sessions |