Clinical trial NCT04238312: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-01-23
Enrollment: 110
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Heart Rate
timeFrame: baseline
measure: Heart Rate
timeFrame: after 5 minutes
measure: Oxygen saturation
timeFrame: baseline
measure: Oxygen saturation
timeFrame: after 5 minutes
measure: Behavior Evaluation
timeFrame: baseline
measure: Behavior Evaluation
timeFrame: after 1 week during follow-up sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Sarah Zeitoun, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Amani Khalil, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nadia Wahba, PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Mohamed IS Ahmed, PhD
role: STUDY_CHAIR
References:
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.
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.
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.