Protocol summary
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Study aim
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In this study, 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 is investigated.
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Design
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In this clinical trial study, 105 children between the ages of 8 to 12 years needed to removing the cast through a random permutation block with an equal number of members in three groups: intervention 1 (music playing), intervention 2 (do playing), and group controls, are clinically tested.
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Settings and conduct
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Heart rate, and children's anxiety levels are recorded before and after the intervention. The research participants are selected from children requiring cast removal at Valiasr Hospital in Arak.
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Participants/Inclusion and exclusion criteria
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Willingness to participant to study by parents and the child; age over 8 years and under 12 years old; having plaster on the upper or lower limbs; the ability to speak and understand Persian; not take sedative or analgesic drugs for one hour before cast removal; lack of hearing and vision problems, mental illness, speech disorders and mental retardation, hyperactivity; lack of compartment syndrome
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Intervention groups
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Intervention group 1: Playing children's music appropriate to the age, gender and interest of children, from 5 minutes before and 2 minutes after removing the cast through wireless headphones; Intervention group 2: selecting and performing computer games, from 5 minutes before to 2 minutes after cast removal, via tablet; Control group: no intervention
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Main outcome variables
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Heart rate and anxiety
General information
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Reason for update
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Study protocol update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180523039793N2
Registration date:
2020-10-09, 1399/07/18
Registration timing:
prospective
Last update:
2025-09-30, 1404/07/08
Update count:
2
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Registration date
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2020-10-09, 1399/07/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-31, 1399/08/10
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Expected recruitment end date
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2021-01-29, 1399/11/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 8 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
105
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-07-26, 1399/05/05
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Ethics committee reference number
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IR.ARAKMU.REC.1399.163
Health conditions studied
1
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Description of health condition studied
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Orthopedics, limb fractures and joint dislocations
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ICD-10 code
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M96.6
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ICD-10 code description
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Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate
2
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Description of health condition studied
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Anxiety
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ICD-10 code
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F41.9
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ICD-10 code description
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Anxiety disorder, unspecified
Primary outcomes
1
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Description
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Anxiety
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Children’s Emotional Manifestation Scale (CEMS), Visual Analogue Scale
2
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Description
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Heart beat
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Timepoint
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Immediately before the intervention, after the intervention
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Method of measurement
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Number of beats per minute - pulse oximeter
3
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Description
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Anxiety
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Facial Anxiety Scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
3
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Description
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Control group: Children in this group did not receive any intervention and cast removal will be will be performed routinely without intervention.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available