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Clinical Trials/NCT05083988
NCT05083988
Unknown
Not 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 enrollmentJune 2022
ConditionsDental Anxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Anxiety
Sponsor
Cairo University
Enrollment
44
Primary Endpoint
preoperative anxiety
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 2022
End Date
December 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omneya Ahmed AbdelRazik saleh

principle investigator

Cairo University

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.

Outcomes

Primary Outcomes

preoperative anxiety

Time Frame: 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

Time Frame: 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 Outcomes

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

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