Anesthesia, Local, Pain, Virtual Reality
Conditions
Keywords
virtual reality, local anesthesia, pain, distraction
Brief 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.
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: 1. 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. 2. 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.
Interventions
DEVICEactive distraction
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.
DEVICEpassive distraction
The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.
Sponsors
Tishreen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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).
Intervention model description
the participants will be divided into ( active distraction group) and ( passive distraction group )
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dental pain | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dental pain and anxiety | during the injection of local anesthesia | using mi band 3 to recording the pulse |
Countries
Syria
Outcome results
None listed