Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) as an audiovisual distraction method to audio distraction using music on child's dental anxiety during dental treatment.

Detailed Description
-----------------
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: audiovisual distraction using virtual reality glasses control group :audio distraction using music. in children aged 5-8 years who need dental extraction for primary molars. For both groups: Taking personal data, medical and dental history. Diagnosis and determination of the required treatment. Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter. Using the behavior guidance technique: Intervention group: The Child is introduced to the virtual reality glasses device, and was given instructions on how to use it and was allowed to choose one of previously chosen cartoons to be played during the procedure. Control group: The child is introduced to the headphones and was given instructions on how to use it, and a relaxing music is played during the procedure. Administration of topical anesthesia. Administration of local anesthesia. Check the effectiveness of local anesthesia using dental probe. Extraction of the affected tooth. Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter. Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale . Self-reporting of subjective pain using Visual analogue scale. Post extraction instructions are given to the patient.

Official Title
-----------------
Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)

Conditions
-----------------
Dental Anxiety

Intervention / Treatment
-----------------
* Device: virtual reality glasses
* Device: music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 5-8 years. Children without any mental or systemic disorder. Children need extraction of primary molars under local anesthesia. Exclusion Criteria: Children with visual impairment. Children with hearing disabilities. Patients or caregivers who refuse to sign the consent.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: audiovisual distraction<br> | Device: virtual reality glasses<br>* a system composed of a head-mounted wide view display placed in front of the eyes and headphones placed in ears, it has the ability to block the real-world stimuli. This could distract the patient from the dental environment, which helps reduce anxiety<br>* Other names: audiovisual distraction;|
| Experimental: audiodistraction<br> | Device: music<br>* Music can be used to distract patients from the anxiety provoking stimulus. It helps the patient to escape from the stressful reality as it activates imaginary. Psychosocially music can offer peace and comfort to patients during dental treatment as it helps in making the environment less threatening.<br>* Other names: audiodistraction;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative anxiety | Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM) | before administration of local anesthesia | 
| postoperative anxiety | using a fingertip pulse oximeter in beat per minute unit (BPM) | immediately after dental extraction | 
| preoperative anxiety | RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety | before administration of local anesthesia | 
| postoperative anxiety | S-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) immediatly after extraction in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety | immediately after dental extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective pain | using Visual analogue scale (vas scale) (0-10) , self reported pain as the child choose a number from 0 to 10 which describes the intensity of his or her pain. 0 =no pain 10=extreme pain. | immediately after extraction. | 
| objective pain | using FLCCS (0-10)valuated by the outcomes assessor. The FLACC scale has five criteria - Faces, 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 dental extraction procedure. |