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

NCT03428282 | Completed DMC

• 1 other identifier: UDDS-Pedo-03-2017
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Inferior Alveolar Nerve Block

Outcome Measures

Primary Outcomes (3)

• 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.

• 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).

• 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

Study Arms (3)

VR Box

EXPERIMENTAL

Inferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention.

Procedure: VR Box

Tablet device

EXPERIMENTAL

Inferior alveolar nerve block will be performed with the aid of a tablet device as a means of distracting patients' attention.

Procedure: Tablet Device

Anesthesia

ACTIVE COMPARATOR

Inferior alveolar nerve block will be performed in the normal manner without any specific intervention to distract patients' attention. Classic anesthesia will be applied.

Drug: Anesthesia

Interventions

VR Box PROCEDURE

Distraction will be made during the injection of the drug using this method.

Also known as: Virtual Reality Eyeglasses

VR Box

Tablet Device PROCEDURE

Distraction will be made during the injection of the drug using this method

Tablet device

Anesthesia DRUG

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

Anesthesia

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• previous dental experience
• systematic or mental disorders.
• definitely negative or negative ratings of Frankel scale
• Any contraindication for regional anesthesia

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Peadodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (6)

• 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.

  PMID: 16951038 BACKGROUND

• 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.

  PMID: 18853287 BACKGROUND

• 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.

  PMID: 24970519 BACKGROUND

• 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.

  PMID: 22583875 BACKGROUND

• 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.

  PMID: 23211912 BACKGROUND

• 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.

  PMID: 26929683 BACKGROUND

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Mohammed Nour Al-Halabi, DDS

  MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Zuhair AlNerabieah, DDS

  MSc student in Pedodontics, University of Damascus Dental School, Syria

  PRINCIPAL INVESTIGATOR

• Nada Bshara, MD MSc Phd

  Associate Professor of Pedodontics, University of Damascus Dental School, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: February 9, 2018
• Study Start: May 15, 2017
• Primary Completion: February 10, 2018
• Study Completion: July 15, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)