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IRCT20260601069600N1 IRCT 2026-07-14 Kashan University of Medical Sciences Effect of Virtual Reality on dental pain Virtual Reality versus Standard Care for Pain Management in Children 6-12 Years Old: A Randomized Controlled Trial 2026-07-16 anticipated 36 Recruiting https://irct.ir/trial/90567 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. N/A Tooth caries and pulpotomy and root canal treatment. Intervention 1: Intervention Group (Virtual Reality Group): Participants in the intervention group received standard care in addition to a virtual reality (VR) intervention using the Shinecon VR G02ED headset connected to an iPhone 12. The VR equipment was first introduced to the child and parent using the Tell–Show–Do technique. Each child then selected one of three animated films (Finding Nemo, Kung Fu Panda 3, or Despicable Me 2) and watched it for 5 minutes before and during the administration of the local anesthetic injection. The total duration of VR exposure was 10–15 minutes. Standard care included behavioral management techniques (storytelling, singing, watching cartoons on a screen, and playing with toys) together with the application of a topical anesthetic gel before the injection. Heart rate and oxygen saturation were monitored using a pulse oximeter before VR use, after VR initiation, during the injection, and after the injection. All local anesthetic injections were administered by the same pediatric dentist. Following completion of the injection, the VR headset was removed and the dental treatment proceeded as planned. Following the treatment, the children's self-reported pain levels during the local anesthetic injection procedure were assessed using the Wong-Baker Faces Pain Scale (WBFS). Intervention 2: Control Group: Participants in the control group received standard care only, which consisted of conventional behavioral management techniques (storytelling, singing, watching cartoons on a screen, and playing with toys) together with the application of a topical anesthetic gel before the local anesthetic injection. No virtual reality headset was used in this group. All local anesthetic injections were administered by the same pediatric dentist. Heart rate and oxygen saturation were monitored using a pulse oximeter before the injection, during the injection, and after the injection. After completion of the injection, dental treatment continued according to the routine clinical protocol. Following the treatment, the children's self-reported pain levels during the local anesthetic injection procedure were assessed using the Wong-Baker Faces Pain Scale (WBFS). No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Ali Mohammad Nickfarjam
Kashan University of Medical Sciences, Hekmat Street, Qotb e Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715973449 +98 31 5558 8883 nickfarjam-a@kaums.ac.ir Kashan University of Medical Sciences scientific Leila Shokrizadeh Arani
Kashan University of Medical Sciences, Hekmat Street, Qotb e Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715973449 +98 31 5558 8883 shokrizadeh-l@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Children aged 6 to 12 years, classified as American Society of Anesthesiologists (ASA) physical status I or II (indicating a healthy patient or one with mild systemic disease). 3.Absence of visual or auditory impairments. Good general physical health. Absence of visual or auditory impairments. No documented history of epilepsy, seizures, or cardiovascular conditions. No cognitive impairments, balance disorders (e.g., vertigo), or active conditions such as nocturnal pain, infection, or inflammation. No prior history of sedative injections, or a history where the most recent injection occurred more than six months before the study. No previous experience with virtual reality (VR) headsets. No documented history of anxiety disorders. A score of 25 or above on the Screen for Child Anxiety Related Disorders (SCARED) questionnaire, suggesting the absence of clinically significant anxiety. Written informed consent provided by a parent or legal guardian, along with assent from the child participant. 6 years 12 years Both History of motion sickness, nausea, or vomiting. Current treatment for psychiatric disorders (e.g., psychosis, post-traumatic stress disorder) or developmental/intellectual disabilities. A known history of epilepsy or seizures. A known history of cardiovascular disease. Presence of nocturnal pain, active infection, or inflammation. Any prior use of VR headsets. Patients presenting for tooth extraction or treatment of dental infections who had no history of prior invasive medical or dental procedures. A score below 25 on the SCARED questionnaire, indicating potential anxiety disorders. Current treatment for psychiatric disorders (e.g., psychosis, PTSD) or developmental/intellectual disabilities. Use of eyeglasses, due to potential interference with the VR headset fit and visual experience. K02 Dental caries Behavior Behavior Intervention Group (Virtual Reality Group): Participants in the intervention group received standard care in addition to a virtual reality (VR) intervention using the Shinecon VR G02ED headset connected to an iPhone 12. The VR equipment was first introduced to the child and parent using the Tell–Show–Do technique. Each child then selected one of three animated films (Finding Nemo, Kung Fu Panda 3, or Despicable Me 2) and watched it for 5 minutes before and during the administration of the local anesthetic injection. The total duration of VR exposure was 10–15 minutes. Standard care included behavioral management techniques (storytelling, singing, watching cartoons on a screen, and playing with toys) together with the application of a topical anesthetic gel before the injection. Heart rate and oxygen saturation were monitored using a pulse oximeter before VR use, after VR initiation, during the injection, and after the injection. All local anesthetic injections were administered by the same pediatric dentist. Following completion of the injection, the VR headset was removed and the dental treatment proceeded as planned. Following the treatment, the children's self-reported pain levels during the local anesthetic injection procedure were assessed using the Wong-Baker Faces Pain Scale (WBFS). Control Group: Participants in the control group received standard care only, which consisted of conventional behavioral management techniques (storytelling, singing, watching cartoons on a screen, and playing with toys) together with the application of a topical anesthetic gel before the local anesthetic injection. No virtual reality headset was used in this group. All local anesthetic injections were administered by the same pediatric dentist. Heart rate and oxygen saturation were monitored using a pulse oximeter before the injection, during the injection, and after the injection. After completion of the injection, dental treatment continued according to the routine clinical protocol. Following the treatment, the children's self-reported pain levels during the local anesthetic injection procedure were assessed using the Wong-Baker Faces Pain Scale (WBFS). Dental Pain. Timepoint: During anesthesia injection (during the intervention). Method of measurement: Wong-Baker Faces Pain Scale (WBFPS). Kashan University of Medical Sciences Approved 2026-06-28 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Hekmat Street, Qotb e Ravandi Boulevard, Kashan, Isfahan Province, Iran Kashan Isfehan Iran (Islamic Republic of)