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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
RESPeRATE™
Tell, Show and Do technique
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RESPeRATE™

Tell, Show and Do technique

Arm 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.

Outcomes

Primary Outcome Measures

Heart Rate
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Heart Rate
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Oxygen saturation
Oxygen saturation will be monitored using an oximeter
Oxygen saturation
Oxygen saturation will be monitored using an oximeter
Behavior Evaluation
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Behavior Evaluation
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive

Secondary Outcome Measures

Full Information

First Posted
January 18, 2020
Last Updated
August 19, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04238312
Brief Title
Respiratory Biofeedback Device and Reduction of Dental Anxiety Associated With Local Anesthesia in Children
Official Title
The Effect of a Respiratory Biofeedback Device on Reduction of Dental Anxiety Associated With Local Anesthesia in Children: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RESPeRATE™
Arm Type
Experimental
Arm 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.
Arm Title
Tell, Show and Do technique
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
RESPeRATE™
Intervention Description
Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.
Intervention Type
Behavioral
Intervention Name(s)
Tell, Show and Do technique
Intervention Description
Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).
Primary Outcome Measure Information:
Title
Heart Rate
Description
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Time Frame
baseline
Title
Heart Rate
Description
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Time Frame
after 5 minutes
Title
Oxygen saturation
Description
Oxygen saturation will be monitored using an oximeter
Time Frame
baseline
Title
Oxygen saturation
Description
Oxygen saturation will be monitored using an oximeter
Time Frame
after 5 minutes
Title
Behavior Evaluation
Description
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Time Frame
baseline
Title
Behavior Evaluation
Description
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Time Frame
after 1 week during follow-up sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Zeitoun, M.Sc
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amani Khalil, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nadia Wahba, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed IS Ahmed, PhD
Organizational Affiliation
Faculty of Medicine, Alexandria University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
21365307
Citation
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.
Results Reference
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PubMed Identifier
17559456
Citation
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.
Results Reference
background
PubMed Identifier
31519334
Citation
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.
Results Reference
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Respiratory Biofeedback Device and Reduction of Dental Anxiety Associated With Local Anesthesia in Children

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