Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools

Inferior Alveolar Nerve Block Clinical Trial

Official title:

Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428282
• Other study ID #: UDDS-Pedo-03-2017
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: July 2018
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 15, 2018
• Est. primary completion date: February 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Inferior Alveolar Nerve Block

Intervention

Procedure:
• VR Box
Distraction will be made during the injection of the drug using this method.
• Tablet Device
Distraction will be made during the injection of the drug using this method

Drug:
• Anesthesia
Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Peadodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. — View 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. — View Citation

Fakhruddin KS, El Batawi H, 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):470-5. doi: 10.4103/1305-7456.172637. — View 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. — View 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. — View 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: 2008/39/smw-12224. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain levels	using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'.	five minutes following the inferior alveolar nerve block injection.
Primary	Anxiety levels	This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale employing an external evaluator in which all of the body responses will be recorded once the needle penetrate the oral tissue.; (0 low anxiety and pain level - 10 high anxiety and pain level)	Within the first minute of injecting the needle into the oral mucosa (oral tissues).
Primary	Change in physiological pulse rate	using Finger Pulse Oximeter	(1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug