Clinical trial NCT05083988: Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment
Official title: Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 44
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: preoperative anxiety
timeFrame: before administration of local anesthesia
measure: postoperative anxiety
timeFrame: immediately after dental extraction
measure: preoperative anxiety
timeFrame: before administration of local anesthesia
measure: postoperative anxiety
timeFrame: immediately after dental extraction
Secondary outcomes:
measure: subjective pain
timeFrame: immediately after extraction.
measure: objective pain
timeFrame: during dental extraction procedure.
Other outcomes:
Locations:
Study officials:
References:
citation: CustOdio NB, Cademartori MG, Azevedo MS, Mendes MA, Schardozim LR, Costa LRRSD, Goettems ML. Efficacy of audiovisual distraction using eyeglasses during dental care: a randomized clinical trial. Braz Oral Res. 2021 Feb 12;35:e26. doi: 10.1590/1807-3107bor-2021.vol35.0026. eCollection 2021.
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