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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-11-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GROUP A1

The children with dental procedures not requiring administration of LA were assigned to Group A. Divide the children in Group A into two sub-groups(Group A1 \& A2) Patients included in Group A1 randomly assigned to receive no VR

Group Type NO_INTERVENTION

No interventions assigned to this group

GROUP A2

The children with dental procedures not requiring administration of LA were assigned to Group A. Divide the children in Group A into two sub-groups(Group A1 \& A2) Patients included in Group A2 randomly assigned to receive VR-The iWear

Group Type EXPERIMENTAL

VR-The iWear

Intervention Type DEVICE

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

GROUP B1

the children with dental procedures requiring administration of LA were assigned to Group Divided the children in Group B into two sub-groups (Group B1 \& B2) Patients included in Group B1 randomly assigned to receive no VR

Group Type NO_INTERVENTION

No interventions assigned to this group

GROUP B2

the children with dental procedures requiring administration of LA were assigned to Group Divided the children in Group B into two sub-groups (Group B1 \& B2) Patients included in Group B2 randomly assigned to receive VR-The iWear

Group Type EXPERIMENTAL

VR-The iWear

Intervention Type DEVICE

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

Interventions

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VR-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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes