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IRCT20180523039793N2 IRCT 2020-10-09 Arak University of Medical Sciences Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years 2020-10-31 anticipated 105 Complete https://irct.ir/trial/51221 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research participants are selected using a convenience sampling method from children requiring cast removal at Valiasr Hospital in Arak. They are then randomly assigned in equal numbers to three groups; Intervention 1 (passive distraction with music), Intervention 2 (active distraction with video games), and the control group, using block randomization with software. These groups undergo a clinical trial. N/A Condition 1: Orthopedics, limb fractures and joint dislocations. Condition 2: Anxiety. Intervention 1: Intervention group 1: Inactive Distraction based on playing music; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, for children in intervention group 1 (music therapy), from 5 minutes before the cast removal and during the procedure, as well as 2 minutes after the removing the cast, music appropriate to the age, sex and interest of the child is selected and played. All of the music that is used, has a beat of 80-60 beats per second and a volume of 40 to 50 decibels, and all of them have a smooth and uniform rotation melodic rhythm, and none of them are stimulating, sad or exciting. Playing the music is according to each child's situation via wireless headphones. Parents are asked not to talk to their children during the intervention. Other factors that may be used to reduce the child's stress (due to disruption of the assessment process) will also be avoided during the intervention. Intervention 2: Intervention group 2: Active Distraction based on computer games; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, children will play games via tablet according to their age, gender and interest from 5 minutes before and 2 minutes after cast removal. Intervention 3: Control group: Children in this group did not receive any intervention and cast removal will be will be performed routinely without intervention. 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 There is no more information
public Ali Safdari
Arak University of Medical Sciences, Sardasht, Basij Square
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3505 asafdari.nu@gmail.com Arak University of Medical Sciences scientific Razieh Mokhtari
Arak University of Medical Sciences, Sardasht, Basij Square
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3505 razieh.mokhtari91@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age over 8 years and under 12 years Have a upper or lower limb plastered Willingness to participant to study by parents and the child and signing the consent form at the beginning of the study Able to speak and understand Persian language Full consciousness and lack of drowsiness Child’s ability to answer the researcher's questions and cooperate during the test 8 years 12 years Both Hearing and vision problems (Completely not hearing and not seeing despite the use of assistive devices) Mental illness (According to the statement of parents) Compartment syndrome Speech disorders and mental retardation, hyperactivity (According to the statement of parents) Pervasive anxiety disorders (According to the statement of parents) Take sedative or analgesic drugs for one hour before cast removal M96.6 F41.9 Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate Anxiety disorder, unspecified Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Inactive Distraction based on playing music; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, for children in intervention group 1 (music therapy), from 5 minutes before the cast removal and during the procedure, as well as 2 minutes after the removing the cast, music appropriate to the age, sex and interest of the child is selected and played. All of the music that is used, has a beat of 80-60 beats per second and a volume of 40 to 50 decibels, and all of them have a smooth and uniform rotation melodic rhythm, and none of them are stimulating, sad or exciting. Playing the music is according to each child's situation via wireless headphones. Parents are asked not to talk to their children during the intervention. Other factors that may be used to reduce the child's stress (due to disruption of the assessment process) will also be avoided during the intervention. Intervention group 2: Active Distraction based on computer games; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, children will play games via tablet according to their age, gender and interest from 5 minutes before and 2 minutes after cast removal. Control group: Children in this group did not receive any intervention and cast removal will be will be performed routinely without intervention. Anxiety. Timepoint: Before intervention and after intervention. Method of measurement: Children’s Emotional Manifestation Scale (CEMS), Visual Analogue Scale. Heart beat. Timepoint: Immediately before the intervention, after the intervention. Method of measurement: Number of beats per minute - pulse oximeter. Anxiety. Timepoint: Before intervention and after intervention. Method of measurement: Facial Anxiety Scale. Arak University of Medical Sciences Approved 2020-07-26 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Sardasht, Basij Square Arak Markazi Iran (Islamic Republic of)