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Clinical Trials/NCT05083988
NCT05083988UnknownNot Applicable

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

Cairo University0 sites44 target enrollmentStarted: June 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
44
Primary Endpoint
preoperative anxiety

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:

  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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
5 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

audiovisual distraction

Experimental

Intervention: virtual reality glasses (Device)

audiodistraction

Experimental

Intervention: music (Device)

Outcomes

Primary Outcomes

preoperative anxiety

Time Frame: before administration of local anesthesia

Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)

postoperative anxiety

Time Frame: immediately after dental extraction

using a fingertip pulse oximeter in beat per minute unit (BPM)

Secondary Outcomes

  • subjective pain(immediately after extraction.)
  • objective pain(during dental extraction procedure.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Omneya Ahmed AbdelRazik saleh

principle investigator

Cairo University

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