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IRCT20120109008665N13 IRCT 2021-04-05 Semnan University of Medical Sciences The effect of distraction on pain intensity and physiological indicators before orthopedic surgery in children The effect of distraction on pain intensity and physiological indicators before orthopedic surgery in children 2021-04-21 anticipated 60 Complete https://irct.ir/trial/55260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The samples will be assigned randomly to the experimental and control groups using the Random Block method. In this method, A represents the experimental group, and B represents the control group, Blinding description: Participants are randomly assigned to groups using double random blocks containing letters A and B, each identifies the experimental or control groups. Participants, the outcome assessor, and the data analyst are unaware of the allocation of individuals to experimental and control groups. N/A Acute pain due to fracture. Intervention 1: Intervention group: In order to perform the intervention in the experimental group, after sufficient explanations about the study objectives and work method, during the introduction and establishing a trusting relationship, written consent will be obtained from the parents of children who meet the inclusion criteria. Then the pain and physiological indicators are measured before the intervention and the game begins in the presence of the parents. In this study, the bubble maker game will be used to create a distraction, during which the researcher and the child will make bubbles using the bubble maker game. The game lasts for 10 minutes. Pain and physiological indicators are also measured immediately after the game and ten minutes after it is done. Intervention 2: Control group: In the control group, patients will receive only routine care without any additional intervention. Evaluations and measurements will be performed at the beginning of the study, 10 minutes and 20 minutes later. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is En No more information.
public Hassan Babamohamadi
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4192 babamohammady2007@gmail.com Semnan University of Medical Sciences scientific Hassan Babamohamadi
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4192 babamohammady2007@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) No history of hospitalization No underlying disease Getting a fracture for the first time Awareness of time, place and person Have a minimum pain score of 4 on the pain behavioral scale Age between 3-6 years Lack of hearing and vision problems and retardation Diagnosis of supracondylar closed fractures of the humerus Lack of receive analgesic for up to 3 hours before the intervention 3 years 6 years Both No pain Illness and inability to continue participating in research Child restlessness and intolerance to research conditions Reluctance to continue participating in research G89.11 Acute pain due to trauma Behavior N/A Intervention group: In order to perform the intervention in the experimental group, after sufficient explanations about the study objectives and work method, during the introduction and establishing a trusting relationship, written consent will be obtained from the parents of children who meet the inclusion criteria. Then the pain and physiological indicators are measured before the intervention and the game begins in the presence of the parents. In this study, the bubble maker game will be used to create a distraction, during which the researcher and the child will make bubbles using the bubble maker game. The game lasts for 10 minutes. Pain and physiological indicators are also measured immediately after the game and ten minutes after it is done. Control group: In the control group, patients will receive only routine care without any additional intervention. Evaluations and measurements will be performed at the beginning of the study, 10 minutes and 20 minutes later. The severity of the pain. Timepoint: Before the intervention (game), immediately after the game and ten minutes after it. Method of measurement: Pain-induced behavioral reactions scale (Face, Legs, Activity, Cry, Consolability). Physiologic indicators (Systolic BP, Diastolic BP, Mean arterial pressure, and Pulse). Timepoint: Before the intervention (game), immediately after the game and ten minutes after it. Method of measurement: Saadat Portable monitor for the pediatric ward of Shafa Yahyaeian Hospital. Semnan University of Medical Sciences Approved 2021-03-09 Semnan University of Medical Sciences Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)