Trials / Completed
CompletedNCT04238312
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Nourhan M.Aly · Academic / Other
- Sex
- All
- Age
- 7 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2018-12-15
- Primary completion
- 2019-10-18
- Completion
- 2020-01-15
- First posted
- 2020-01-23
- Last updated
- 2020-08-20
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04238312. Inclusion in this directory is not an endorsement.