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

Nourhan M.Aly

Status: Completed

Conditions: Anxiety

Treatments: Behavioral: Tell, Show and Do technique; Device: RESPeRATE™

Study type: Interventional

Funder types: Other

Identifiers

NCT04238312

Respiratory biofeedback device

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

RESPeRATE™

Experimental group

Description:

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.

Treatment:

Device: RESPeRATE™

Tell, Show and Do technique

Active Comparator group

Treatment:

Behavioral: Tell, Show and Do technique