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

Not Applicable

• Conditions: Dental Anxiety
• Interventions: Device: virtual reality glasses; Device: music

• Registration Number: NCT05083988
• Lead Sponsor: Cairo University

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:

1. Taking personal data, medical and dental history.

2. Diagnosis and determination of the required treatment.

3. Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter.

4. 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.

5. Administration of topical anesthesia.

6. Administration of local anesthesia.

7. Check the effectiveness of local anesthesia using dental probe.

8. Extraction of the affected tooth.

9. Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter.

10. Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale .

11. Self-reporting of subjective pain using Visual analogue scale.

12. Post extraction instructions are given to the patient.

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-12
• Study Start: 2022-06
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
audiovisual distraction	virtual reality glasses	-
audiodistraction	music	-

Primary Outcome Measures

Name	Time	Method
preoperative anxiety	before administration of local anesthesia	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
postoperative anxiety	immediately after dental extraction	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

Secondary Outcome Measures

Name	Time	Method
subjective pain	immediately after extraction.	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.
objective pain	during dental extraction procedure.	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