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

The Effect of a Respiratory Biofeedback Device on Reduction of Dental Anxiety Associated With Local Anesthesia in Children: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Device: RESPeRATE™; Behavioral: Tell, Show and Do technique

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: RESPeRATE™; Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.
Active Comparator: Tell, Show and Do technique	Behavioral: Tell, Show and Do technique; Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).

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

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Sarah Zeitoun, M.Sc, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Amani Khalil, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Nadia Wahba, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Mohamed IS Ahmed, PhD, Faculty of Medicine, Alexandria University, Egypt

Publications and helpful links

General Publications

• Morarend QA, Spector ML, Dawson DV, Clark SH, Holmes DC. The use of a respiratory rate biofeedback device to reduce dental anxiety: an exploratory investigation. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):63-70. doi: 10.1007/s10484-011-9148-z.
• Howard KE, Freeman R. Reliability and validity of a faces version of the Modified Child Dental Anxiety Scale. Int J Paediatr Dent. 2007 Jul;17(4):281-8. doi: 10.1111/j.1365-263X.2007.00830.x.
• Chipps J. Psychological therapies for the management of chronic and recurrent pain in children and adolescents: A Cochrane review summary. Int J Nurs Stud. 2021 Jan;113:103393. doi: 10.1016/j.ijnurstu.2019.103393. Epub 2019 Aug 16. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2018
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: January 18, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Respiratory biofeedback device

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No