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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05083988
Enrollment
44
Registered
2021-10-19
Start date
2022-06-30
Completion date
2022-12-31
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

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.

Interventions

DEVICEvirtual reality glasses

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

DEVICEmusic

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
preoperative anxietybefore administration of local anesthesiaPreoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)
postoperative anxietyimmediately after dental extractionusing a fingertip pulse oximeter in beat per minute unit (BPM)

Secondary

MeasureTime frameDescription
subjective painimmediately 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 painduring 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

Contacts

Primary Contactomneya Ahmed Abdelrazik, B.D.S Cairo university
omneya.saleh@dentistry.cu.edu.eg00201016300046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026