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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238312
• Other study ID #: Respiratory biofeedback device
• Status: Completed
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: August 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 15, 2020
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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

Behavioral:
• Tell, Show and Do technique
Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Chipps J. Psychological therapies for the management of chronic and recurrent pain in children and adolescents: A Cochrane review summary. Int J Nurs Stud. 2019 Aug 16:103393. doi: 10.1016/j.ijnurstu.2019.103393. [Epub ahead of print] — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	A finger pulse oximeter will be placed on the finger of the left hand of the child.	baseline
Primary	Heart Rate	A finger pulse oximeter will be placed on the finger of the left hand of the child.	after 5 minutes
Primary	Oxygen saturation	Oxygen saturation will be monitored using an oximeter	baseline
Primary	Oxygen saturation	Oxygen saturation will be monitored using an oximeter	after 5 minutes
Primary	Behavior Evaluation	using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive	baseline
Primary	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