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IRCT20190702044077N1 IRCT 2019-09-29 Arak University of Medical Sciences Effect of Adiou Distraction Methods on Pain and Anxiety During Dental Treatment The Comparison of effectivness of Adiou Distraction Methods on Pain and Anxiety of 4-8 years old Paediatric Patient During Dental Treatment 2019-11-22 anticipated 60 Complete https://irct.ir/trial/40524 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Randomization method: Simple Randomization Unit: Individual Randomization tool: software will be used to place persons in two groups based on the preference and delay of the method and in the third session for selection the maxillary quadrant, 60 very similar envelopes, half of which are zero and half of which are one, are used. In the first treatment session, move the envelopes, then select one envelope for each child, if the number is zero,.reatment on the right and if the number is one treatment on the left will be done. The concealment is carried out by envelopes of a black and same shape that are not clearly identified, Blinding description: The present study is a single blind study. In this study, the assistant dentist who records the indices is unaware of how individuals are assigned to the groups and the type of intervention performed at each session to treat individuals. According to the present study, since the intervention of all participants during the treatment is to listen to the audio story or music, it is not possible to keep the participants blind and the participants will notice What kind of media do they listen to either way.The present study is a preventive study and participants' blindness did not have a clear effect on the results. N/A The amount of pain and anxiety of a child during dental treatment. Intervention 1: Intervention group: Playing the audio story, in this study three audio stories for a total of 30 minutes with the voice of Ms. Pegah Razavi,from a MP3 player model of the RM-1101 by JBL wired headset during treatment for the child, is used. Intervention 2: Intervention group: Music playing, In this study, both kind of relaxed and happy chidlish music will be used as a 30-minute package. which is distributed by a MP3 player model of the RM-1101 by JBL wired headset during treatment for the child. Yes - There is a plan to make this available What will be shared: All data are publishable When: One year after publishing results To whom: All researcher in university and research centers Conditions: There are no conditions Where to obtain: Dr Hamid Sarlak How to obtain: Request a person by email Investigating university affiliation of the requesting person send information via email the maximum time of this process is one month. Comments:
public Hamid Sarlak
Fifth Floor, Mir Ahmad Building, Azod Corner, Shahid Beheshti Street
Arak Iran (Islamic Republic of) 3813634159 +98 86 3222 3794 Dr.hamidsarlak@yahoo.com Arak University of Medical Sciences scientific Maedeh Sadeghi
Narges Hostel, Basij Square, Sardasht
Arak Iran (Islamic Republic of) 3819693345 009833721472 dr_maedehsadeghi@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients should be candidates for double sided pulpotomy and stainless steel crown (SSC) in the first or second primary maxillary molars of the same type They are genetically, systemic and able to learn healthy They have no history of dental treatment and hospitalization In Frankel cooperation scale should be in positive or definietly positive position 4 years 8 years Both Existence of severe pain or obvious need for treatment on one side earlier of opposite side that excludes the study from a random state Lack of cooperation for attending medical sessions Prevention Prevention Intervention group: Playing the audio story, in this study three audio stories for a total of 30 minutes with the voice of Ms. Pegah Razavi,from a MP3 player model of the RM-1101 by JBL wired headset during treatment for the child, is used. Intervention group: Music playing, In this study, both kind of relaxed and happy chidlish music will be used as a 30-minute package. which is distributed by a MP3 player model of the RM-1101 by JBL wired headset during treatment for the child. Pulse rate. Timepoint: Heart rate at first and second sessions once and for all treatment sessions (third and fourth sessions) three times is measured and recorded by the dentist's assistant.1. One minute after the start of the method of distraction 2. During injection Local anesthetic 3. During pulp exposure. Method of measurement: To determine the heart rate, the digital electronic device OXY300 (Microlife AG, Widnau, Switzerland) will be used by placing the probe on the child's left hand finger. Face pain rate. Timepoint: After starting the distraction method. Method of measurement: The subjective evaluation of pain is performed by the FPR scale after the starting distraction method wich is recorded by the child using it's scoring image, and determined score by the next session in the presence of another distraction method are compared. Evaluation of pain by eye, movement and sound (SEM). Timepoint: After starting the distraction method. Method of measurement: The Objective scale used to measure pain is a SEM scale that evaluates the status of the child's sound, eyes, and movements according to the score table. The score for this scale is recorded by the dentist's assistant after the start of the specific method of distraction. The score is compared with the score of the next session in the presence of the another distraction method. Arak University of Medical Sciences Approved 2019-07-28 Ethics committee of Arak university of Medical Sciences Academic complex of the Great Prophet, Basij Square, Sardasht Arak Markazi Iran (Islamic Republic of)