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IRCT20230106057065N1 IRCT 2023-01-11 Shahid Beheshti University of Medical Sciences A comparative evaluation of audial and visual behavioral management techniques on the anxiety of children undergoing dental treatment:a clinical trial MCDAS (Faces version of Modified child dental anxiety scale) A comparative evaluation of audial and visual behavioral management techniques on the anxiety of 6-12 year old children undergoing dental treatment:a clinical trial 2022-12-16 anticipated 90 Complete https://irct.ir/trial/67917 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation rule According to the sample size, 3 intervention groups are placed inside balls in a lottery container, and referring patients randomly remove the balls from the container without replacement, Blinding description: Informed consent was obtained from the patient's parents to participate in the 3 groups: tell-show-do, audio, video randomly selected by their child. Collection of physiological information pulse rate and oxygen saturation level of blood (pulse oximetry) and information related to the child's anxiety level (MCDAS) and her level of acceptance are collected by a person who is not aware of the intervention and study. The collected data is also analyzed by a person who is not aware of the study. It should be noted that the intervention is performed by one person, who is a pediatric dentistry resident. N/A The level of anxiety of children undergoing dental treatment. Intervention 1: Control group: Tell-show-do, In this method, all the tools used are explained to the child before the treatment. Intervention 2: Intervention group: Audial group, In this method, the child's favorite story, poem, song or music is played by hands-free. Intervention 3: Intervention group: Visual group, in this method, the child's favorite cartoon is played without sound. Yes - There is a plan to make this available What will be shared: The data collected from the study and analysis can be published without mentioning the names of the participants. When: Beginning of the access period after 1402 To whom: Collected data without mentioning the names of the participants will be provided to the researchers for reference if needed to conduct other studies. Conditions: To conduct other studies Where to obtain: To access the data, send a message to the email of Fateme Kalantari. How to obtain: After receiving the email, the data will be sent with permission from the relevant instructor. Comments:
public Fateme Kalantari
Daneshjou Boulevard, Velenjak
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5351 fa.kalantari1995@gmail.com Shahid Beheshti University of Medical Sciences scientific Fateme Kalantari
Shahid Beheshti University of Medical Science, Daneshjou Boulvard, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5351 fa.kalantari1995@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The age of the child is between 6 and 12 years No previous experience in dentistry Dental treatments that require anesthesia Absence of mental and systemic diseases 6 years 12 years Both Complex and time-consuming treatment Unusual non-cooperation of the child Dissatisfaction of the patient's parents to participate in the study Behavior Behavior Behavior Control group: Tell-show-do, In this method, all the tools used are explained to the child before the treatment. Intervention group: Audial group, In this method, the child's favorite story, poem, song or music is played by hands-free. Intervention group: Visual group, in this method, the child's favorite cartoon is played without sound. MCDAS: The child's anxiety level is reported by the emoticons shown by the child. Timepoint: Before-during-after treatment. Method of measurement: by emoticons and MCDAS questions. Pulse rate. Timepoint: Before-during-after treatment. Method of measurement: pulse oximeter. Blood oxygen saturation level. Timepoint: Before-during-after treatment. Method of measurement: pulse oximeter. Child acceptance rate. Timepoint: After treatment. Method of measurement: by 3 questions that are asked by the blinded person and the last question includes a visual analog scale that is reported by the child. Age of the patient. Timepoint: Before treatment. Method of measurement: Demographic information sheet. Gender of the patient. Timepoint: Before treatment. Method of measurement: Demographic information sheet. Shahid Beheshti University of Medical Sciences Approved 2022-12-11 Ethics committee of Shahid beheshti University of Medical Sciences Faculty of Dentistry, Shahid Beheshti University, Daneshjou Boulevard, Velenjak Tehran Tehran Iran (Islamic Republic of)