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CompletedNCT03428282Updated Jul 30, 2018

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

An interventional study of VR Box and Tablet Device in Inferior Alveolar Nerve Block, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2018-07-30.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Inferior Alveolar Nerve Block
03

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    VR Box

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

    Procedure: VR Box

  • Experimental
    Tablet device

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

    Procedure: Tablet Device

  • Active comparator
    Anesthesia

    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

  • ProcedureVR Box

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

    Also known as: Virtual Reality Eyeglasses

  • ProcedureTablet Device

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

  • DrugAnesthesia

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

05

What researchers measure

Primary outcomes

  1. Pain levels

    using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'.

    Time frame: five minutes following the inferior alveolar nerve block injection.

  2. 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)

    Time frame: Within the first minute of injecting the needle into the oral mucosa (oral tissues).

  3. Change in physiological pulse rate

    using Finger Pulse Oximeter

    Time frame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug

06

Study locations

1 site
  • Department of Peadodontics, University of Damascus Dental School
    Damascus, DM20AM18, Syrian Arab Republic
07

References and documents

Publications

  • 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. PubMed 16951038 ↗
  • 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. PubMed 18853287 ↗
  • 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. PubMed 24970519 ↗
  • 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. PubMed 22583875 ↗
  • 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. PubMed 23211912 ↗
  • 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. PubMed 26929683 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03428282
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
Feb 9, 2018
Start date
May 15, 2017
Primary completion
Feb 10, 2018
Completion
Jul 15, 2018
Last update
Jul 30, 2018

Study contacts

Mohammed Nour Al-Halabi, DDS
principal investigator · MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
Zuhair AlNerabieah, DDS
principal investigator · MSc student in Pedodontics, University of Damascus Dental School, Syria
Nada Bshara, MD MSc Phd
study director · Associate Professor of Pedodontics, University of Damascus Dental School, Syria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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