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IRCT20171020036896N6 IRCT 2018-05-30 Kerman University of Medical Sciences The Effect of Acupressure on Anxiety and Pain of Local Anesthesia Injection The Effect of Acupressure on Anxiety and Pain of Local Anesthesia Injection in 5-7 Years Children 2018-05-22 anticipated 60 Complete https://irct.ir/trial/30112 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization or unrestricted method will be used and randomization unit is Individual .we will use from Flip the coin from the methods of simple randomization because there are 2 groups in this study that actually the tool of randomization is coin. As one of the study groups, I consider the heads and the other group as tails, and according to the size of the sample(60 person), the coin is toss-up. So the subjects are divided into two groups (anxiety and pain groups). The next step Allocation concealment will be done, In such a way that the allocated group is not known before the assignment of the individual. To achieve this goal, a non-transparent, sealed, random sequence envelope is used . In this way, the statistical specialist will provide 60 envelopes and each of the randomly generated links will be recorded on a card and the cards are arranged in the envelopes . In order to maintain a random sequence, the numbering of envelopes on the outer surface is done in the same order. Finally, the envelops are enclosed and placed in the box, respectively. At the time of the implementation of the study, according to the order of entry of eligible participants, one of the envelopes is opened respectively and will determine the group assigned to that participant. In this study, the assistant of Pediatric Dentistry examines the participants in terms of inclusion and exclusion criteria. Randomization methods are done by a statistical specialist and performance of the study is done by a trained assistant of Pediatric Dentistry, Blinding description: Participants do not know the type of intervention (the main point of acupressure) A researcher who performs local anesthesia is not aware of the type of intervention The data analyzer is also unaware of the groups. N/A anxiety and pain. Intervention 1: Intervention group 1: The application of acupressure in the main point of reduction anxiety. Intervention 2: Intervention group 2: The application of acupressure in the main point of reduction pain. Intervention 3: Control group 1: The application of acupressure in the placebo point of reduction anxiety. Intervention 4: Control group 2: The application of acupressure in the placebo point of reduction pain. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because the study data do not have any other application.
public Dr Hamidreza Poureslami
Pediatric Department, School of Dentistry, Shafa Street, Kerman
Kerman Iran (Islamic Republic of) 7618759689 +34 32119021 poureslami@yahoo.com Kerman University of Medical Sciences scientific Fatemeh Sadat Sajadi
Pediatric Department, School of Dentistry, Shafa Street, Kerman
Kerman Iran (Islamic Republic of) 7618759689 +34 32119021 sajadi@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) the children in the age of 5-7 years old that have two carious primary molars in mandible or maxilla that required treatment with local anesthesia there were any wound or scars in acupressure points 5 years 7 years Both history of systemic disease mental retardation history of unfavorable dentistry experiment or hospitalization history of severe dental pain & acute dental infection Lack of cooperation V Mental and behavioural disorders Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group 1: The application of acupressure in the main point of reduction anxiety Intervention group 2: The application of acupressure in the main point of reduction pain Control group 1: The application of acupressure in the placebo point of reduction anxiety Control group 2: The application of acupressure in the placebo point of reduction pain The level of anxiety. Timepoint: before and after performance of acupressure. Method of measurement: visual analogue scale. The level of pain. Timepoint: before and after performance of acupressure. Method of measurement: visual analogue scale. Kerman University of Medical Sciences Approved 2018-05-29 The Ethic Committee of Kerman University of Medical Sciencess Vice-Chancellor for Research, Kerman University of Medical Sciences, Tahmasbabad cross, Jahad Street,Kerman Kerman Kerman Iran (Islamic Republic of)