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

January 22, 2025 updated by: King Abdullah University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, P.O.Box 3030
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: 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
Device: 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
No Intervention: 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
Experimental: 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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Wong-Baker Faces
Time Frame: 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
through study completion, an average of 2 years
Visual Analog Scale (VAS)
Time Frame: 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.
through study completion, an average of 2 years
The 'Face, Legs, Activity, Cry, Consolability' (FLACC) scale
Time Frame: 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
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Research Grant No: 20190440 (Other Grant/Funding Number: Jordan University of Science and Technology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

JANUARY 2025 TILL MAY 2025

IPD Sharing Access Criteria

ANYONE ASKING FOR THE INFROMATION.IT WILL BE PROVIDED THROUGH A LINK AND IT WILL BE RAW DATA

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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