Inferior Alveolar Nerve BlockNCT03428282
Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools
A study testing VR Box, Tablet Device and Anesthesia in people with Inferior Alveolar Nerve Block, run by Damascus University at 1 site in Syria.
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… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Inferior Alveolar Nerve Block
- What is being tested?
- VR Box, Tablet Device and Anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSyria
- Study dates
- 15 May 2017to 15 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- previous dental experience
- systematic or mental disorders.
- definitely negative or negative ratings of Frankel scale
- Any contraindication for regional anesthesia
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Peadodontics, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block
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.
Read more
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.
- Conditions
- Inferior Alveolar Nerve Block
- Being tested
- VR Box, Tablet Device, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR BoxProcedure or surgery
Also called Virtual Reality Eyeglasses
Distraction will be made during the injection of the drug using this method.
Tablet DeviceProcedure or surgery
Distraction will be made during the injection of the drug using this method
AnesthesiaDrug
Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.
| Study group | Role | What they receive |
|---|---|---|
| VR Box | Experimental | Inferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention. Receives: 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. Receives: 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. Receives: Drug: Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels
using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'.
Measured: 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)
Measured: Within the first minute of injecting the needle into the oral mucosa (oral tissues).
Change in physiological pulse rate
using Finger Pulse Oximeter
Measured: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start15 May 2017
- Primary completion10 Feb 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Nour Al-Halabi, DDS, Principal investigator, MSc student in Pedodontics, University of Damascus Dental School, Damascus, SyriaZuhair AlNerabieah, DDS, Principal investigator, MSc student in Pedodontics, University of Damascus Dental School, SyriaNada Bshara, MD MSc Phd, Study director, Associate Professor of Pedodontics, University of Damascus Dental School, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428282
- Sponsor's protocol ID
- UDDS-Pedo-03-2017
- Status last verified
- Jul 2018
- First submitted
- 26 Dec 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 16951038Wang 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 18853287Al-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 24970519El-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 22583875Hoge 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 23211912Fakhruddin 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block
- ClinicalTrials.gov ID
- NCT03428282
- Acronym / sponsor ID
- UDDS-Pedo-03-2017
- Conditions
- Inferior Alveolar Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR Box | Experimental | Procedure: VR BoxInferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention. |
| Tablet device | Experimental | Procedure: Tablet DeviceInferior alveolar nerve block will be performed with the aid of a tablet device as a means of distracting patients' attention. |
| Anesthesia | Active comparator | Drug: AnesthesiaInferior alveolar nerve block will be performed in the normal manner without any specific intervention to distract patients' attention. Classic anesthesia will be applied. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- previous dental experience
- systematic or mental disorders.
- definitely negative or negative ratings of Frankel scale
- Any contraindication for regional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR BoxAlso: Virtual Reality EyeglassesDistraction will be made during the injection of the drug using this method. | Procedure or surgery | VR Box |
| Tablet DeviceDistraction will be made during the injection of the drug using this method | Procedure or surgery | Tablet device |
| AnesthesiaAnesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment. | Drug | Anesthesia |
Primary outcome
Pain levels
Time frame: five minutes following the inferior alveolar nerve block injection.
using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'.
Anxiety levels
Time frame: Within the first minute of injecting the needle into the oral mucosa (oral tissues).
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)
Change in physiological pulse rate
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
using Finger Pulse Oximeter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Background: PubMed 16951038Madhok 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.
- Background: PubMed 18853287Wang 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.
- Background: PubMed 24970519Al-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.
- Background: PubMed 22583875El-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.
- Background: PubMed 23211912Hoge 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.
- Background: PubMed 26929683Fakhruddin 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.
- Individual participant dataSharing planned: No
Related trials for Inferior Alveolar Nerve Block
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry
Recruiting
Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars
Anesthetic Efficacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Box, Tablet Device and Anesthesia in people with Inferior Alveolar Nerve Block, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels (time frame: five minutes following the inferior alveolar nerve block injection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03428282, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.