Clinical trial NCT03428282: Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools
Official title: Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inferior Alveolar Nerve Block
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of two different audiovisual distraction techniques (Audio Video eyeglasses "VR BOX"/ Tablet) in the management of anxious pediatric patients during inferior alveolar nerve block

Group A (Control group): IAN will be administrated with basic behavior guidance techniques and without using any type of distraction aids.

Group B: IAN will be administrated with using AV eyeglasses "VR BOX" and wireless headphone.

Group C: IAN will be administrated with using tablet device and wireless headphone

All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator

Detailed description: This study will evaluate the effectiveness of two types of distraction aids that contain video using (tablet device or VR BOX eyeglasses) and audio distraction using wireless headphone. pain and anxiety will be evaluated during inferior alveolar nerve block using three behavioral scales, Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator".

The first measure of heart pulse rate will be recorded directly when the patient seated comfortably on the dental chair, after anesthesia, the second heart pulse rate will be taken and the child patients will ask to choose a face that describe their status from one of the Wong Baker faces scale.

For each child patient, all of the body responses will be recorded during the whole procedure and then will be evaluated by an external assessor to determine the children behavioral score according to FLACC scale.

Eligibility criteria: Inclusion Criteria:

1. age between 6 and 10 years.
2. no previous dental experience.
3. definitely positive or positive ratings of Frank scale.
4. Need of IAN block for any dental treatment.

Exclusion Criteria:

1. previous dental experience
2. systematic or mental disorders.
3. definitely negative or negative ratings of Frankel scale
4. Any contraindication for regional anesthesia

Primary outcomes:
measure: Pain levels
timeFrame: five minutes following the inferior alveolar nerve block injection.
measure: Anxiety levels
timeFrame: Within the first minute of injecting the needle into the oral mucosa (oral tissues).
measure: Change in physiological pulse rate
timeFrame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Peadodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammed Nour Al-Halabi, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: MSc student in Pedodontics, University of Damascus Dental School, Syria
name: Zuhair AlNerabieah, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Pedodontics, University of Damascus Dental School, Syria
name: Nada Bshara, MD MSc Phd
role: STUDY_DIRECTOR
References:
citation: Madhok M, Teele M. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Sep;118(3):1321; author reply 1321-2. doi: 10.1542/peds.2006-1351. No abstract available.
citation: Wang ZX, Sun LH, Chen AP. The efficacy of non-pharmacological methods of pain management in school-age children receiving venepuncture in a paediatric department: a randomized controlled trial of audiovisual distraction and routine psychological intervention. Swiss Med Wkly. 2008 Oct 4;138(39-40):579-84. doi: 10.4414/smw.2008.12224.
citation: Al-Namankany A, Petrie A, Ashley P. Video modelling and reducing anxiety related to dental injections - a randomised clinical trial. Br Dent J. 2014 Jun;216(12):675-9. doi: 10.1038/sj.bdj.2014.497.
citation: El-Sharkawi HF, El-Housseiny AA, Aly AM. Effectiveness of new distraction technique on pain associated with injection of local anesthesia for children. Pediatr Dent. 2012 Mar-Apr;34(2):e35-8.
citation: Hoge MA, Howard MR, Wallace DP, Allen KD. Use of video eyewear to manage distress in children during restorative dental treatment. Pediatr Dent. 2012 Sep-Oct;34(5):378-82.
citation: Fakhruddin KS, Hisham EB, Gorduysus MO. Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent. 2015 Oct-Dec;9(4):470-475. doi: 10.4103/1305-7456.172637.