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IRCT20220315054300N1 IRCT 2022-04-18 Arak University of Medical Sciences Effect of prize distraction technique on reducing children's pain and anxiety in dentistry Comparison of pain and anxiety rate in children in the aged 3 to 7 years during dental procedures using two different behavioral guidance techniques, conversation distraction and "prize-distraction" 2022-04-19 anticipated 60 Complete https://irct.ir/trial/62529 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: Block randomization method will be used to randomize the patients participating in the study. For this purpose,size 4 blocks will be selected and according to them, the randomization sequence of patients will be determined (AB or BA). Also, to select the maxillary quadrant in the first treatment session, 60 completely similar envelopes are used, half of them have the letter L and the other half have the letter R inside. In the first treatment session, the envelopes are turned upside down several times to change the place of all of them, then one envelope will be selected for each child, if it is the letter R, the treatment is done on the right and if it is the letter L, the treatment is done on the left, Blinding description: The present study is a single blind. In this study, the statistical analyzer is unaware of how individuals are assigned to groups and the type of intervention performed in each session to treat individuals. The observer, as the scorer of the Sound Eye Motor(SEM) scale and the number of Pulse Rate per minute(PR/min) and the recorder of them, can not be blinded because he is necessarily aware of the type of behavioral guidance by listening to the dentist. N/A Pain and anxiety in children during dental procedures that lead to non-cooperative behavior and difficulty in treating them.. Intervention 1: "Intervention group 1": treatment of pulpotomy and stainless steel crown of maxillary D teeth similarly on the right and left side with the presence of one of the behavioral guidance methods (prize distraction) on one side of the maxilla and in the presence of another method ( Intervention 2) is performed on the opposite side. The "prize distraction" technique begins about 20 seconds before picking up the local anesthetic syringe and continues for 1 minute to 20 seconds after the local anesthetic is injected (about 100 seconds in total). Local anesthesia is performed by an experienced dentist with the infiltration technique, without showing the anesthetic syringe to the child. In this technique, the dentist uses reward-oriented sentences to distract the child from the painful stimulus. The dentist speaks as slowly as possible so that the child's attention is fully absorbed by the dentist and the sentences are visualized in his mind. Intervention 2: "Intervention group 2": Pulpotomy and treatment of stainless steel crown of maxillary D teeth performed in the presence of one of the behavioral guidance methods ( conversation distraction) In "conversation distraction", the dentist defines the "story of the tooth germ". this technique begins about 20 seconds before picking up the local anesthetic syringe and continues for 1 minute to 20 seconds after the local anesthetic is injected (about 100 seconds in total). Local anesthesia is performed by an experienced dentist with the infiltration technique, without showing the anesthetic syringe to the child. The dentist speaks as slowly as possible so that the child's attention are fully aware of him and the sentences are visualized in his mind. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Hamid Sarlak
Mirahmad Building., Corner of Azod st.,Abbas Abad st
Arak Iran (Islamic Republic of) 3813634159 +98 86 3222 3794 Dr.hamidsarlak@yahoo.com Arak University of Medical Sciences scientific Hamid Sarlak
Mirahmad Building., Corner of Azod st.,Abbas Abad st
Arak Iran (Islamic Republic of) 3813634159 +98 86 3222 3794 Dr.hamidsarlak@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Children in 3 to 7 years old. Children who are genetically, systemically and physically healthy. All children in need of pulpotomy and SSC treatment of maxillary first primary molars bilaterally. Children without any history of dental treatment and hospitalization. Children with a positive or definitely positive status based on Frankl's cooperation criteria. 3 years 7 years Both Behavior Behavior "Intervention group 1": treatment of pulpotomy and stainless steel crown of maxillary D teeth similarly on the right and left side with the presence of one of the behavioral guidance methods (prize distraction) on one side of the maxilla and in the presence of another method ( Intervention 2) is performed on the opposite side. The "prize distraction" technique begins about 20 seconds before picking up the local anesthetic syringe and continues for 1 minute to 20 seconds after the local anesthetic is injected (about 100 seconds in total). Local anesthesia is performed by an experienced dentist with the infiltration technique, without showing the anesthetic syringe to the child. In this technique, the dentist uses reward-oriented sentences to distract the child from the painful stimulus. The dentist speaks as slowly as possible so that the child's attention is fully absorbed by the dentist and the sentences are visualized in his mind. "Intervention group 2": Pulpotomy and treatment of stainless steel crown of maxillary D teeth performed in the presence of one of the behavioral guidance methods ( conversation distraction) In "conversation distraction", the dentist defines the "story of the tooth germ". this technique begins about 20 seconds before picking up the local anesthetic syringe and continues for 1 minute to 20 seconds after the local anesthetic is injected (about 100 seconds in total). Local anesthesia is performed by an experienced dentist with the infiltration technique, without showing the anesthetic syringe to the child. The dentist speaks as slowly as possible so that the child's attention are fully aware of him and the sentences are visualized in his mind. Pain score in Sound Eye Motor criteria. Timepoint: During the local anesthesia process. Method of measurement: 1.Sound Eye Motor (SEM) This scale will be scored as an objective criterion for measuring the amount of pain. , The child's eyes and body condition will be determined and recorded by a trained dental assistant who is aware of this criterion, these scores will be compared with the scores of the next treatment session that uses another method of behavioral guidance. 2. Face Pain Rating Scale (FPR): This scale is used as a subjective criterion for measuring pain, which will be scored by the child himself using Wong-Baker images after local anesthesia, and the score is determined by the score. The next session is compared. Anxiety level based on pulse rate per minute. Timepoint: 1- Three minutes after the child sits on the unit at the beginning of the treatment session 2- When using the behavioral guidance method during local anesthesia injection. Method of measurement: Pulse oximeter device: One of the symptoms of anxiety is an increase in heart rate. To measure the level of anxiety, the number of pulses per minute (Pulse rate / min) can be used. Positioning the device probe on the index finger of the child's left hand will be used and the score recorded in the two sessions will be compared. Arak University of Medical Sciences Approved 2022-03-15 Ethics Committee of Arak University of Medical Sciences No. 37 , Dastgheib Cross.,Behzisti St., Daneshgah Ave., Arak Town Arak Markazi Iran (Islamic Republic of)