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Effect of Immersive Virtual Reality on Pain in Different Dental Procedures in Children

Effect of Immersive Virtual Reality on Pain in Different Dental Procedures in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06794788
Enrollment
154
Registered
2025-01-27
Start date
2019-07-01
Completion date
2023-11-01
Last updated
2025-01-27

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

Conditions

Fissure Sealant, FLUORIDE THERAPY, Impression Taking for Space Maintainers, Pulp Therapy, Restorations, SCALING, Space Maintainer, Stainless-steel Crown, TOOTH Extraction

Keywords

VIRTUAL REALITY, PAIN, DENTAL

Brief summary

the current study aims to assess virtual reality as an effective pain management technique for children undergoing different dental procedures. The iWear is the immersive virtual reality device was used for this study from (Vuzix®, Rochester, New York, USA). The iWear consists of a lightweight high-end pair of video headphones that contain pair of VR goggles

Detailed description

The peadiatric dentist examined children to assess their needs. At the screening, a full mouth oral examination was performed. Different dental procedures needed were determined based on the outcome of the clinical examination performed. Some of these dental procedures did not require administration of local anesthesia (LA), such as fissure sealant, space maintainer, fluoride therapy, impression taking for space maintainers, and scaling. Other dental procedures require the administration of LA , such as stainless-steel crown, pulp therapy, restorations, and extraction (Figure 2). The peadiatric dentist divided the children into two groups (Group A & B) according to the need for usage of LA. The children with dental procedures not requiring administration of LA were assigned to Group A, and the children with dental procedures requiring administration of LA were assigned to Group B. A computer-generated random number was used to randomly divide the children in Group A into two sub-groups(Group A1 & A2) according to the usage of VR. Patients included in Group A1 randomly assigned to receive no VR. On the other hand, patients included in Group A2 randomly assigned to receive VR. Also, children in Group B were randomly assigned into two sub-groups (Group B1 & B2) to receive no VR or VR respectively.

Interventions

DEVICEVR-The iWear

The immersive virtual reality device was used for this study from(Vuzix®, Rochester, New York, USA). The iWear consists of a lightweight high-end pair of video headphones that contain pair of VR goggles

Sponsors

Jordan University of Science and Technology
CollaboratorOTHER
King Abdullah University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Children aged 5-12 years * Good general health, * Taking no medications, * Willingness to participate in the study

Exclusion criteria

* Subjects with a convulsive disorder, * Subjects with a history of serious vestibular abnormalities, * Subjects with musculoskeletal disorders, or developmental delay taking psychotropic drugs

Design outcomes

Primary

MeasureTime frameDescription
The Wong-Baker Facesthrough study completion, an average of 2 yearsused to measure the level of pain in the current study. The Wong-Baker Faces is a self-report measure that consists of six cartoon faces with different facial expressions. The Wong-Baker Faces scale starts from zero to 10
Visual Analog Scale (VAS)through study completion, an average of 2 yearsThe VAS is a self-report measure that consists of a 10-centimeters horizontal line that indicates the current level of pain. The children were asked to give ratings using 0-10 scales with lower numbers indicates less pain, while the higher numbers indicate higher pain.
The 'Face, Legs, Activity, Cry, Consolability' (FLACC) scalethrough study completion, an average of 2 yearss a behavioral pain observation scale used commonly to measure pain during a procedure. The FLACC are reliable and valid common pain measurement tool used as an external evaluator to measure procedural pain. Each category is scored on a 0-2 scale, resulting in a total 0-10 score. The external evaluator used a 0-10 scale, with cut points indicating (0) Relaxed, (1-3) Mild discomfort, (4-6) Moderate pain, or (7-10) Severe discomfort/pain

Countries

Jordan

Outcome results

None listed

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