Clinical trial NCT06794788: Effect of Immersive Virtual Reality on Pain in Different Dental Procedures in Children
Official title: Effect of Immersive Virtual Reality on Pain in Different Dental Procedures in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fissure Sealant
Space Maintainer
Impression Taking for Space Maintainers
FLUORIDE THERAPY
SCALING
Stainless-steel Crown
Pulp Therapy
Restorations
TOOTH Extraction
Keywords: VIRTUAL REALITY
PAIN
DENTAL
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2025-01-27
Enrollment: 154
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Wong-Baker Faces
timeFrame: through study completion, an average of 2 years
measure: Visual Analog Scale (VAS)
timeFrame: through study completion, an average of 2 years
measure: The 'Face, Legs, Activity, Cry, Consolability' (FLACC) scale
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
References:
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