Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual reality headset, Audio-visual distraction with 2D cartoons, Tell-show-do with verbal distraction.
- Who it may be relevant to
- Registry conditions: Dental Anxiety in Children, Pain Perception. Basic parameters: 6 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Oman
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"
Overview
The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are: Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques? Does virtual reality distraction reduce pain perception during dental extraction? Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain. Participants will: Wear VR glasses to watch immersive 3D cartoons, or Watch 2D cartoons with headset, or Receive the conventional tell-show-do technique with verbal distraction. Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).
Interventions
- Device Virtual reality headset
Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception. - Behavioral Audio-visual distraction with 2D cartoons
Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception. - Behavioral Tell-show-do with verbal distraction
Children receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation.
Primary outcome measures
- Child Dental Anxiety (Self-Report) [Time frame: Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)]
- Child Dental Anxiety (Observation-based Assessment) [Time frame: Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction]
- 3a: Physiological Monitoring - Pulse Rate [Time frame: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction]
- 3b: Physiological Monitoring - Oxygen Saturation (SpO₂) [Time frame: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction]
Secondary outcome measures (2)
- Pain Perception (Self-Report) [Time frame: at the end of the procedure]
- Child Behavior (Observation) [Time frame: Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure]
Eligibility criteria
Inclusion criteria
- Children aged 6 to 10 years
- Classified as ASA class 1 or 2 (healthy or with mild systemic disease)
- Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures
- Children with NO previous exposure to invasive dental procedure
- No prior experience using VR glasses
- Requiring extraction of mandibular deciduous molar under local anesthesia
Exclusion criteria
- ASA 3 and above
- Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures
- Special needs ( intellectual and developmental)
- Children on psychotropic medication
- Children wearing glasses
- Presence of intra-oral swelling
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Oman · 2 centers
- Sultan Qaboos University Hospital - Dental & Maxillofacial Department — Muscat
- The Medical City of Military and Security Service (Dental Center-AlKhoudh ) — Muscat
Publications
- Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7. PMID 38087294
- Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1. PMID 39465519
- Gomez-Polo C, Vilches AA, Ribas D, Castano-Seiquer A, Montero J. Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. J Clin Med. 2021 Jul 7;10(14):3019. doi: 10.3390/jcm10143019. PMID 34300185
Identifiers
NCT: NCT07693764 · PED-VR-2026-A · OMSBoard-2026