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

NCT04238312 | Completed

• 1 other identifier: Respiratory biofeedback device
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

RESPeRATE™

EXPERIMENTAL

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™

Tell, Show and Do technique

ACTIVE COMPARATOR

Behavioral: Tell, Show and Do technique

Interventions

RESPeRATE™ DEVICE

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

RESPeRATE™

Tell, Show and Do technique BEHAVIORAL

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

Tell, Show and Do technique

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (3)

• 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.

  PMID: 21365307 BACKGROUND

• 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.

  PMID: 17559456 BACKGROUND

• 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.

  PMID: 31519334 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sarah Zeitoun, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health and Statistician

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

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 23, 2020
• Study Start: December 15, 2018
• Primary Completion: October 18, 2019
• Study Completion: January 15, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

EG (1)