Virtual Reality versus Standard Care for Pain Management in Children 6-12 Years Old: A Randomized Controlled Trial

Evaluation of the effect of virtual reality on pain levels in children aged 6 to 12 years during dental procedures

Randomized controlled clinical trial, with parallel groups and a 1:1 allocation ratio, on 36 children aged 6 to 12 years. A block method (block size 4) was used for randomization. Due to the nature of the intervention, blinding of participants and dentist was not possible, but the data analyst was blinded to group allocation.

This study was conducted in at Labkhand Dental Clinic, Kashan, on children aged 6 to 12 years. After screening and assessment with the SCARED questionnaire, participants were randomly assigned to two intervention and control groups. The intervention included the use of a virtual reality headset for 10 to 15 minutes simultaneously with local anesthetic injection. no Blinding

Inclusion criteria: 1.Age 6–12 years 2.Healthy (ASA I or II) 3.No prior VR experience 4.SCARED score ≥ 25 (no significant anxiety) 5.Parental consent and child assent Exclusion criteria: 1.History of seizures, epilepsy, or heart disease 2.Motion sickness, nausea, or vomiting 3.Psychiatric or developmental disorders 4.Active infection, inflammation, or nocturnal pain 5.Wearing eyeglasses 6.SCARED score < 25 (significant anxiety)

Virtual reality group (18 people): Use of VR headset along with conventional behavioral techniques and local anesthetic gel. Control group (18 people): Conventional behavioral techniques and local anesthetic gel, without use of VR.

Primary outcome: Pain level during local anesthetic injection, measured using the Wong-Baker Faces Pain Scale (WBFPS) – self-report. Secondary outcomes: Heart rate (HR) and blood oxygen saturation (SpO₂) measured via pulse oximetry at multiple stages; anxiety measured using SCARED questionnaire at baseline.

Participants will be randomly allocated to either the intervention group (sedation with virtual reality [VR] distraction) or the control group (sedation without VR distraction) using a block randomization method with a fixed block size of four. The allocation sequence will be generated by an independent statistician and will be maintained by a third party to ensure allocation concealment. Investigators and clinical personnel responsible for participant recruitment will be blinded to the allocation sequence throughout the enrolment process. Group assignments will be revealed only after participant enrolment has been completed, thereby minimizing the risk of selection bias. Due to the nature of the intervention, blinding of participants and the treating clinician will not be feasible, as the use of the VR headset will be readily identifiable during the procedure. However, statistical analyses will be conducted by a blinded data analyst, and group allocations will be coded before analysis to reduce the potential for analytical bias.

Deidentified individual participant data (IPD) will not be shared in order to protect participant confidentiality and in accordance with the ethical approval of the study and institutional policies. Furthermore, the informed consent process did not include a plan for sharing individual participant-level data with external researchers.

Study documents, including the study protocol, the statistical analysis plan (SAP), and the informed consent form template. These documents describe the study design, methodology, outcome measures, statistical methods, and ethical procedures used in the trial. No deidentified individual participant data (IPD) or participant-level datasets will be shared.

The study documents will become available upon publication of the primary study results in a peer-reviewed journal and will remain available for five years. Approved documents will be provided electronically upon reasonable request to eligible researchers.

The study documents (including the study protocol, the statistical analysis plan, and the informed consent form template) will be available only to qualified researchers affiliated with recognized academic or research institutions. Requests must be submitted using a valid institutional email address and sent directly to the corresponding author. Applicants should clearly describe the purpose of their request. The documents may be used solely for scientific research and educational purposes. Commercial use, including use by pharmaceutical companies, medical device manufacturers, or other commercial organizations, is not permitted. Recipients must agree not to redistribute the documents to third parties without prior written permission. A response will normally be provided within 14 working days after receipt of a complete request.

The study documents (including the study protocol, the statistical analysis plan, and the informed consent form template) may be used exclusively for scientific research, educational purposes, systematic reviews, meta-analyses, and methodological research. Access will be granted only after review and approval of a written request by the corresponding author. Applicants must provide a clear description of the intended use of the requested documents and agree to use them solely for non-commercial purposes. Redistribution of the documents to third parties or any attempt to identify study participants is strictly prohibited. No deidentified individual participant data (IPD) will be shared.

The study documents (including the study protocol, the statistical analysis plan, and the informed consent form template) can be obtained by contacting the corresponding author via email. Approved documents will be provided electronically upon request. Correspondence should be directed to the corresponding author: Dr. Leila Shokrizadeh Arani, Assistant Professor, Health Information Management Research Center, Kashan University of Medical Sciences, Kashan, Iran. Email: shokrizadeh-l@kaums.ac.ir

Researchers requesting access to the study documents (including the study protocol, the statistical analysis plan, and the informed consent form template) should submit a written request by email to the corresponding author. The request should include the applicant's full name, institutional affiliation, institutional email address, and a brief description of the intended use of the requested documents. The corresponding author will review the request to ensure that it is consistent with the study objectives and ethical requirements. If approved, the requested study documents will be provided electronically within 7–14 business days. No individual participant data (IPD) or any information that could identify study participants will be shared.