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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-15

Study Completion Date

2020-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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RESPeRATE™

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.

Group Type EXPERIMENTAL

RESPeRATE™

Intervention Type DEVICE

Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.

Tell, Show and Do technique

Group Type ACTIVE_COMPARATOR

Tell, Show and Do technique

Intervention Type BEHAVIORAL

Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).

Interventions

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RESPeRATE™

Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.

Intervention Type DEVICE

Tell, Show and Do technique

Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No