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

Not Applicable

Completed

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

• Registration Number: NCT06794788
• Lead Sponsor: King Abdullah University Hospital

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-11-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Wong-Baker Faces	through study completion, an average of 2 years	used 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 years	The 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) scale	through study completion, an average of 2 years	s 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

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan