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

NCT06794788 | Completed

• 1 other identifier: Research Grant No: 20190440
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• 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

  through study completion, an average of 2 years

• 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.

  through study completion, an average of 2 years

• 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

  through study completion, an average of 2 years

Study Arms (4)

GROUP A1

NO INTERVENTION

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 A2

EXPERIMENTAL

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

GROUP B1

NO INTERVENTION

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 B2

EXPERIMENTAL

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

Interventions

VR-The iWear 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 A2; GROUP B2

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, P.O.Box 3030, Jordan

Location

Related Publications (6)

• 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.

  PMID: 27409593 BACKGROUND

• 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.

  PMID: 11014398 BACKGROUND

• 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.

  PMID: 34172032 BACKGROUND

• 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.

  PMID: 31866714 BACKGROUND

• 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.

  PMID: 17935593 BACKGROUND

• 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.

  PMID: 33245591 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 27, 2025
• Study Start: July 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: JANUARY 2025 TILL MAY 2025
• Access Criteria: ANYONE ASKING FOR THE INFROMATION.IT WILL BE PROVIDED THROUGH A LINK AND IT WILL BE RAW DATA

Locations

JO (1)