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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Device: RESPeRATE™; Behavioral: Tell, Show and Do technique

• Registration Number: NCT04238312
• Lead Sponsor: Nourhan M.Aly

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.

Study Timeline

• Study Start: 2018-12-15
• Primary Completion: 2019-10-18
• Study Completion: 2020-01-15
• Study First Submitted: 2020-01-18
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-23
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RESPeRATE™	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.
Tell, Show and Do technique	Tell, Show and Do technique	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt