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Fissure SealantNCT06794788

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

A study testing VR-The iWear in people with Fissure Sealant and Space Maintainer, run by King Abdullah University Hospital at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 5 to 12 yearsHealthy volunteers can take part
What is being tested?
VR-The iWear
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteJordan
Study dates
1 Jul 2019to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Jordan University of Science and Technology

    Irbid, P.O.Box 3030

Other trials in Jordan

About this study

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

Read the 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.

Being tested
VR-The iWear
Keywords
VIRTUAL REALITY, PAIN, DENTAL
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR-The iWearDevice

    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 groups in NCT06794788
Study groupRoleWhat they receive
GROUP A1No interventionThe 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 A2ExperimentalThe 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
Receives: Device: VR-The iWear
GROUP B1No interventionthe 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 B2Experimentalthe 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
Receives: Device: VR-The iWear

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Wong-Baker Faces

    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

    Measured: through study completion, an average of 2 years

  2. Visual Analog Scale (VAS)

    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.

    Measured: through study completion, an average of 2 years

  3. The 'Face, Legs, Activity, Cry, Consolability' (FLACC) scale

    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

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start1 Jul 2019
  3. Primary completion1 Jul 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06794788
Sponsor's protocol ID
Research Grant No: 20190440
Other IDs
Research Grant No: 20190440
Status last verified
Jan 2025
First submitted
16 Jan 2025
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD, all IPD that underlie results in a publication

Publications

  • Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.

    PubMed 27409593

  • Hoffman HG, Patterson DR, Carrougher GJ. Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. Clin J Pain. 2000 Sep;16(3):244-50. doi: 10.1097/00002508-200009000-00010.

    PubMed 11014398

  • Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.

    PubMed 34172032

  • Koticha P, Katge F, Shetty S, Patil DP. Effectiveness of Virtual Reality Eyeglasses as a Distraction Aid to Reduce Anxiety among 6-10-year-old Children Undergoing Dental Extraction Procedure. Int J Clin Pediatr Dent. 2019 Jul-Aug;12(4):297-302. doi: 10.5005/jp-journals-10005-1640.

    PubMed 31866714

  • Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent. 2007 Nov;17(6):391-406. doi: 10.1111/j.1365-263X.2007.00872.x.

    PubMed 17935593

  • Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.

    PubMed 33245591

Questions about this trial

What is this clinical trial studying?

A study testing VR-The iWear in people with Fissure Sealant and Space Maintainer, run by King Abdullah University Hospital at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Wong-Baker Faces (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06794788, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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