Virtual RealityNCT05129943
Efficacy of VR Distraction During Local Anesthesia in Children
A study testing active distraction and passive distraction in people with Virtual Reality and Anesthesia, Local, run by Latakia University at 1 site in Syria.
Trial summary
The aim of this study is to compare between active distraction (video game) and passive distraction (cartoon video) using a Virtual Reality ( VR ) device, in reducing injection pain and anxiety associated with local anesthesia in children. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Anesthesia, Local, Pain
- What is being tested?
- active distraction and passive distraction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSyria
- Study dates
- 21 Feb 2022to 5 Jul 2022
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children need a simple treatment for temporary teeth in the mandibular jaw
- children with positive and definitely positive behavior according to frankl behavior classification
- children with no known allergy to local anesthesia
- children with no previous treatment from the same researcher
- children with no previous experience in using the VR device
Who cannot join
- children with negative and definitely negative behavior according to frankl behavior classification
- children with known allergy to local anesthesia
- children with emergency dental treatment in the mandibular jaw
- children with previous treatment from the same researcher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Active and Passive Virtual Reality Distraction During Local Anesthesia in Children
The aim of this study is to compare between active distraction (video game) and passive distraction (cartoon video) using a Virtual Reality ( VR ) device, in reducing injection pain and anxiety associated with local anesthesia in children.
Read the detailed description
This comparative study is a double blinded controlled randomized clinical trial which includes 82 healthy 6-10 years old children with positive and definitely positive behavior according to Frankl Rating Scale with no known allergy to local anesthesia, no emergency dental treatment, no previous treatment from the same researcher and no previous experience in using the Virtual Reality ( VR ) device.
the participants will be allocated and treated at department of pediatric dentistry, faculty of dentistry, Tishreen university and a written consent will be obtained from the parents.
The random-numbers table will be used to divide 82 participants in to two groups:
- The active distraction group, which will be receiving the injection of local anesthesia while using the VR device with a video game and a Play Station 4 ( PS4 ) controller.
- The passive distraction group, which will be receiving the injection of local anesthesia while using VR device watching a cartoon video.
All the participants will receive an inferior alveolar nerve block with semi supine position.
- Conditions
- Virtual Reality, Anesthesia, Local, Pain
- Being tested
- active distraction, passive distraction
- Keywords
- virtual reality, local anesthesia, pain, distraction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active distractionDevice
The subject receives the injection of local anesthesia while playing a game on a mobile phone mounted on the VR device using a PS4 controller.
passive distractionDevice
The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.
| Study group | Role | What they receive |
|---|---|---|
| active distraction group | Active comparator | local anesthesia with video game using VR device Receives: Device: active distraction |
| passive distraction group | Active comparator | local anesthesia with cartoon video using VR device Receives: Device: passive distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental pain
evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain).
Measured: during the injection of local anesthesia
dental pain
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
Measured: Immediately after the injection of local anesthesia
Secondary outcomes (1)
dental pain and anxiety
using mi band 3 to recording the pulse
Measured: during the injection of local anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start21 Feb 2022
- Primary completion24 Jun 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Model description
- the participants will be divided into ( active distraction group) and ( passive distraction group )
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- oula kara Mohammed, DDS, Principal investigator, Latakia UniversityNabih Raslan, Dr., Study chair, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129943
- Sponsor's protocol ID
- VR distraction in children
- Status last verified
- Feb 2022
- First submitted
- 11 Nov 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Active and Passive Virtual Reality Distraction During Local Anesthesia in Children
- ClinicalTrials.gov ID
- NCT05129943
- Acronym / sponsor ID
- VR distraction in children
- Conditions
- Virtual Reality, Anesthesia, Local, Pain
- Keywords
- virtual reality, local anesthesia, pain, distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 22 Nov 2021 (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 compare between active distraction (video game) and passive distraction (cartoon video) using a Virtual Reality ( VR ) device, in reducing injection pain and anxiety associated with local anesthesia in children.
Detailed description
This comparative study is a double blinded controlled randomized clinical trial which includes 82 healthy 6-10 years old children with positive and definitely positive behavior according to Frankl Rating Scale with no known allergy to local anesthesia, no emergency dental treatment, no previous treatment from the same researcher and no previous experience in using the Virtual Reality ( VR ) device.
the participants will be allocated and treated at department of pediatric dentistry, faculty of dentistry, Tishreen university and a written consent will be obtained from the parents.
The random-numbers table will be used to divide 82 participants in to two groups:
- The active distraction group, which will be receiving the injection of local anesthesia while using the VR device with a video game and a Play Station 4 ( PS4 ) controller.
- The passive distraction group, which will be receiving the injection of local anesthesia while using VR device watching a cartoon video.
All the participants will receive an inferior alveolar nerve block with semi supine position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the participants will be divided into ( active distraction group) and ( passive distraction group )
| Arm | Type | Receives |
|---|---|---|
| active distraction group | Active comparator | Device: active distractionlocal anesthesia with video game using VR device |
| passive distraction group | Active comparator | Device: passive distractionlocal anesthesia with cartoon video using VR device |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- healthy children need a simple treatment for temporary teeth in the mandibular jaw
- children with positive and definitely positive behavior according to frankl behavior classification
- children with no known allergy to local anesthesia
- children with no previous treatment from the same researcher
- children with no previous experience in using the VR device
Key exclusion criteria (4 listed)
- children with negative and definitely negative behavior according to frankl behavior classification
- children with known allergy to local anesthesia
- children with emergency dental treatment in the mandibular jaw
- children with previous treatment from the same researcher
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 |
|---|---|---|
| active distractionThe subject receives the injection of local anesthesia while playing a game on a mobile phone mounted on the VR device using a PS4 controller. | Device | active distraction group |
| passive distractionThe subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device. | Device | passive distraction group |
Primary outcome
dental pain
Time frame: during the injection of local anesthesia
evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain).
dental pain
Time frame: Immediately after the injection of local anesthesia
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
1 secondary outcome
dental pain and anxiety
Time frame: during the injection of local anesthesia
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 14 Jul 2022.
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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.
oula kara Mohammed, DDS principal investigator
Latakia University
Nabih Raslan, Dr. study chair
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active distraction and passive distraction in people with Virtual Reality and Anesthesia, Local, run by Latakia 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 5 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 14 Jul 2022. 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?
dental pain (time frame: during the injection of local anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2022.