]>
IRCT20250712066454N1 IRCT 2025-09-04 Kerman University of Medical Sciences the effect of augmented reality glasses in reducing pain and anxiety Investigating the effect of augmented reality (AR) technology in reducing pediatric pain and anxiety in dentistry 2025-09-23 anticipated 32 Complete https://irct.ir/trial/84726 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Before the treatment begins, written informed consent is obtained from the parents. Participants are randomly assigned to two groups. For randomization, sealed envelopes are prepared. Treatment Envelope 1: The first visit involves local anesthesia with the use of Meta Quest 3 headset, during which the child is fully immersed in a virtual environment. The second visit involves anesthesia without the headset. Treatment Envelope 2: The first visit involves local anesthesia without the headset, and the second visit involves anesthesia with the Meta Quest 3 headset and full immersion in the virtual environment. The envelopes are sealed and placed in a box. A clinic secretary who is unaware of their contents randomly selects one envelope for each participant. The assigned intervention is then registered and performed by a pediatric dentistry resident. The second visit is conducted by the same resident two weeks after the first visit. N/A Pain and anxiety caused by dentistry. Intervention 1: Intervention Group: The local anesthetic injection for all teeth will be administered by a pediatric dentistry specialist resident under the supervision of the relevant professor. The treatment steps and the use of the Meta Quest 3 augmented reality headset (Meta, USA) will be thoroughly and precisely explained to the resident. Before the treatment session begins, the use of the headset will be explained to the child in simple terms for 3 minutes, and they will be allowed to interact with it to feel comfortable. The child will wear the headset 2 minutes before the injection to acclimate to the virtual environment. A 3D animation titled 'Jungle Quest,' specifically designed to reduce anxiety and featuring nature and jungle animals, will be played. This animation is free of stressful content and includes calm, relaxing music. While immersed in this augmented reality environment, a 1.5 mL local anesthetic injection of Lidocaine 1:80000 (Perzocaine, Darou Pakhsh Company, Tehran, Iran) will be administered using a 30-gauge needle. The headset will remain on the child’s head for 1 minute after the injection is complete. The total duration of headset use will be approximately 5 minutes for each injection. Other medical equipment includes an A3 model pulse oximeter (made in China), which will be placed on the child's finger solely for monitoring vital signs. Intervention 2: Control Group: Local anesthesia for all teeth will be administered by a pediatric dentistry specialist assistant under the supervision of the relevant professor. The treatment steps will be thoroughly and precisely explained to the assistant; however, no Meta Quest 3 augmented reality headset (Meta, USA) or any other distraction tool will be used.The procedure will be as follows: Before the injection, the child will be seated in the dental unit. An A3 fingertip pulse oximeter (CN, China) will be placed on the child’s index finger, and their heart rate will be recorded prior to the intervention. No headset or distraction device will be applied. Local anesthesia will be administered using lidocaine 1:80000 (Perzocaine, Darou Pakhsh Company, Tehran, Iran).During the injection, a trained observer will record the child’s pain using the FLACC scale. The child’s heart rate during the injection will be recorded using the A3 fingertip pulse oximeter (CN, China). After the injection, the child’s heart rate will again be recorded with the A3 fingertip pulse oximeter (CN, China). The child will then self-report their pain level using the Wong-Baker scale. Treatment will proceed afterward. At the end of the session, the child will complete the DAS questionnaire to assess their level of anxiety. Yes - There is a plan to make this available What will be shared: Only a portion of the data is shared, such as the original outcome information. When: Access period begins 6 months after results are published. To whom: Only for researchers working in academic and scientific institutions Conditions: For researchers Where to obtain: Faroukh@kmu.ac.ir; Dr.mojtaba.madadi@gmail.com How to obtain: 1 month Comments:
public Elham Faroukh Ghisor
Kerman University of Medical Sciences, Shafa crossroad, Jomhuri Eslami Blvd.
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 Faroukh@kmu.ac.ir Kerman University of Medical Sciences scientific Elham Faroukh Gisor
Kerman University of Medical Sciences, Shafa crossroad, Jomhuri Eslami Blvd.
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 Faroukh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Children aged between 6 and 12 years. Requiring bilateral local anesthetic injection for dental procedures. No systemic diseases such as cardiovascular conditions or severe anxiety disorders. Mentally capable of communication. No known allergy to local anesthetic agents. Written informed consent obtained from the child's parents. 6 years 12 years Both History of severe dental fear or phobia. Visual or neurological impairments preventing the use of AR glasses. Use of analgesic medications within 48 hours prior to treatment. Previous dental treatment experience. History of significant behavioral management issues that hinder clinical cooperation. N/A N/A Intervention Group: The local anesthetic injection for all teeth will be administered by a pediatric dentistry specialist resident under the supervision of the relevant professor. The treatment steps and the use of the Meta Quest 3 augmented reality headset (Meta, USA) will be thoroughly and precisely explained to the resident. Before the treatment session begins, the use of the headset will be explained to the child in simple terms for 3 minutes, and they will be allowed to interact with it to feel comfortable. The child will wear the headset 2 minutes before the injection to acclimate to the virtual environment. A 3D animation titled 'Jungle Quest,' specifically designed to reduce anxiety and featuring nature and jungle animals, will be played. This animation is free of stressful content and includes calm, relaxing music. While immersed in this augmented reality environment, a 1.5 mL local anesthetic injection of Lidocaine 1:80000 (Perzocaine, Darou Pakhsh Company, Tehran, Iran) will be administered using a 30-gauge needle. The headset will remain on the child’s head for 1 minute after the injection is complete. The total duration of headset use will be approximately 5 minutes for each injection. Other medical equipment includes an A3 model pulse oximeter (made in China), which will be placed on the child's finger solely for monitoring vital signs. Control Group: Local anesthesia for all teeth will be administered by a pediatric dentistry specialist assistant under the supervision of the relevant professor. The treatment steps will be thoroughly and precisely explained to the assistant; however, no Meta Quest 3 augmented reality headset (Meta, USA) or any other distraction tool will be used.The procedure will be as follows: Before the injection, the child will be seated in the dental unit. An A3 fingertip pulse oximeter (CN, China) will be placed on the child’s index finger, and their heart rate will be recorded prior to the intervention. No headset or distraction device will be applied. Local anesthesia will be administered using lidocaine 1:80000 (Perzocaine, Darou Pakhsh Company, Tehran, Iran).During the injection, a trained observer will record the child’s pain using the FLACC scale. The child’s heart rate during the injection will be recorded using the A3 fingertip pulse oximeter (CN, China). After the injection, the child’s heart rate will again be recorded with the A3 fingertip pulse oximeter (CN, China). The child will then self-report their pain level using the Wong-Baker scale. Treatment will proceed afterward. At the end of the session, the child will complete the DAS questionnaire to assess their level of anxiety. Pain Level. Timepoint: Immediately after the intervention. Method of measurement: Wong-Baker Scale, Face, Legs, Activity, Cry, Consolability Scale. Physiological Anxiety (Heart Rate). Timepoint: Before the intervention, During the intervention, Immediately after the intervention. Method of measurement: Fingertip Pulse Oximeter. Dental Anxiety (DAS Score). Timepoint: On the same day following the intervention. Method of measurement: Dental Anxiety Questionnaire. Kerman University of Medical Sciences Approved 2025-06-21 Ethics committee of Kerman university of medical sciences Kerman University of Medical Sciences, Shafa crossroad, Jomhuri Eslami Blvd. kerman Kerman Iran (Islamic Republic of)