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IRCT20210108049963N1 IRCT 2021-02-03 Rasht University of Medical Sciences A comparative study of two methods of playing music and the use of 3D audio-visual glasses in controlling pain and anxiety during injection in children Comparative study of the effect of music playback and use of 3D Audiovisual glasses on pain and severity of anxiety rate during injection in 4-10 year-old children referred to Anzali s Dental Clinic 2021-02-06 anticipated 30 Complete https://irct.ir/trial/53571 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Samples will be randomly blocked from children referred to the pediatric ward of Anzali Dental Clinic, which will be injected and treated by a final year student under the supervision of a pediatric dentist. Block randomization will be done in such a way that all possible modes will be written for 3 sessions of treatment in terms of receiving the intervention and 6 modes or blocks will be created. Then 5 people will be randomly placed in each block to get 30 people in the blocks. Block 1: The first session of music - the second session of video - the third session of behavioral control Block 2: The first session of music - The second session of behavioral control - The third session of video Block 3: The first session of the video - the second session of music - the third session of behavioral control Block 4: The first session of the video - the second session of behavioral control - the third session of music Block 5: The first session of behavioral control - the second session of video - the third session of music Block 6: The first session of behavioral control - the second session of music - the third session of video, Blinding description: The FLACC criteria will be used to assess the child's pain. The recording of this scale is done by the assistant so that he does not know the type of intervention, in other words, the study will be done single-blind. The child's face, legs, activity, crying, and submissiveness are assessed. This criterion is classified from zero (completely calm) to 10 (severe pain / anxiety). Also, the child's anxiety will be assessed immediately after the infiltration injection in the posterior maxilla using the FIS (facial image scale). Previously, the assistant explained the smileys and how to show the feeling to the child, and after the injection, the child is asked to mark the appropriate smile depending on the degree of discomfort. N/A Anxiety. Intervention 1: Intervention group: Patients will visit 4 times a week, in the first session will be examined and prescribed radiographs and recorded medical and dental history and completed the file and fluoride prophylaxis. Children who interact negatively or completely negatively with the Frankel scale will be excluded from the study. In the second, third, and fourth sessions, the children will receive the necessary dental treatment, and depending on the block in which they are randomly placed, the first intervention for them is a full-length cartoon for 1 minute while injected with 3D glasses ( Shinecon VR model) is played. Intervention 2: Intervention group: Uncle Purang's music is played by headphones for 1 minute during injection. Intervention 3: Control group:In the basic behavioral control group, the dentist communicates with the patient through speech without the use of distraction (using glasses or playing music). Yes - There is a plan to make this available What will be shared: Only part of the data such as information about reducing pain and anxiety during infiltration injection is shared When: After printing the results To whom: Dentists, Pediatricians, researchers working in academic and scientific institutions Conditions: Using intervention groups such as 3D glasses or music instead of basic behavioral control to reduce pain and anxiety Where to obtain: Guilan University of Medical Sciences International Campus Library How to obtain: Visit the library site of Bandar Anzali International Faculty and search for defended dissertations and approved research projects from 2020onwards Comments:
public Seyedeh hedyeh daneshvar
In front of Caspian and Padideh restaurants, 2 km towards Fooman, Saravan belt, end of Lakan road, Gas Sq.
Rasht Iran (Islamic Republic of) 73774 41941 +98 13 3348 6406 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences scientific Seyedeh hediyeh daneshvar
In front of Caspian and Padideh restaurants, 2 km towards Fooman, Saravan belt, end of Lakan road, Gas Sq.
Rasht Iran (Islamic Republic of) 4194173774 +98 13 3348 6406 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Requires one examination session and three sessions of dental treatment and requires infiltration injection behind the maxilla Parental consent patient The child's consent to the use of distractions Good general health Do not enter children who have epilepsy According to the Frankel scale, positive cooperation (accepts treatment, sometimes shows cautious behavior, sometimes reluctant to follow a dentist but follows him directly) or completely positive (reports dentist That the child has a lot of cooperation in the work process and laughs and enjoys) Lack of pediatric dental history (be the first visit to the dentist) 4 years 10 years Both Need medication to cooperate Medical problems such as history of seizures or seizure disorders, gastrointestinal or balance disorders, eye problems, autism and any other mental illness Children who have a negative or completely negative cooperation according to the Frankl scale The presence of any abscess in the area of the injection site F93.2 Soci In this disorder there is a wariness of strangers and social apprehension or anxiety when encountering new, strange, or socially threatening situations. This category should be used only where such fears arise during the early years, and are both unusual Prevention Prevention Prevention Intervention group: Patients will visit 4 times a week, in the first session will be examined and prescribed radiographs and recorded medical and dental history and completed the file and fluoride prophylaxis. Children who interact negatively or completely negatively with the Frankel scale will be excluded from the study. In the second, third, and fourth sessions, the children will receive the necessary dental treatment, and depending on the block in which they are randomly placed, the first intervention for them is a full-length cartoon for 1 minute while injected with 3D glasses ( Shinecon VR model) is played Intervention group: Uncle Purang's music is played by headphones for 1 minute during injection Control group:In the basic behavioral control group, the dentist communicates with the patient through speech without the use of distraction (using glasses or playing music). Pain score on FLACC criteria. Timepoint: During injection of infiltrator behind the maxilla. Method of measurement: The FLACC criterion will be used to assess the child's pain. The recording of this scale is done by the assistant so that he does not know the type of intervention. The state of the child's face, legs, activity, crying and surrender are evaluated. This criterion is classified from zero (completely calm) to 10 (severe pain / anxiety). Anxiety score on the FIS scale. Timepoint: During injection of infiltrator behind the maxilla. Method of measurement: The child's anxiety will be assessed immediately after the infiltration injection in the posterior part of the maxilla using a facial image scale (FIS), in which the assistant first explains the smileys and how to show the feeling to the child and asks the child after the injection. Depending on the degree of discomfort, mark the appropriate face. Rasht University of Medical Sciences Approved 2021-01-13 Ethics Committee of Guilan University of Medical Sciences In front of 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St. Rasht Guilan Iran (Islamic Republic of)