Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
All the participants will receive an inferior alveolar nerve block with semi supine position.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active distraction group | Active Comparator | local anesthesia with video game using VR device |
|
| passive distraction group | Active Comparator | local anesthesia with cartoon video using VR device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active distraction | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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" ) | Immediately after the injection of local anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| dental pain and anxiety | using mi band 3 to recording the pulse | during the injection of local anesthesia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| oula kara Mohammed, DDS | Tishreen University | Principal Investigator |
| Nabih Raslan, Dr. | Tishreen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tishreen university | Latakia | Syria |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
the participants will be divided into ( active distraction group) and ( passive distraction group )
Not provided
Not provided
the participants will carry the controller with a box to hide the controller (to keep the outcomes assessor blinded) and wear the VR device by an assistant ( to keep investigator blinded).
| passive distraction | Device | The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device. |
|