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IRCT20181104041553N1 IRCT 2019-09-13 Mashhad University of Medical Sciences Comparison of the effect of vibration bee with heat and cold and room temperature on the pain caused by intravenous cannula insertion in children زنبوک ویبره Comparison of the effect of vibration bee with heat and cold on the pain caused by intravenous cannula insertion in children 3 to 6 years 2019-08-31 anticipated 105 Complete https://irct.ir/trial/40131 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The method used to generate a random allocation sequence is blocked. Block randomization ensures that there are no groups between the groups at any time interval during the randomization of a significant imbalance, and at each point the number of participants in each group is equal. Sampling in this research will be that sampling initially will be conducted in a "non-random" way for the purpose of children entering the research and assigning them to 3 groups (groups: vibration bee with heat/ vibration bee with cold/ vibration bee with room temperature) will be random; In this way, the assignment of samples to intervention groups (vibration bee with heat and vibration bee with cold) or control group(vibration bee with room temperature) will be done by random assignment (lottery by blocking). In this intervention, we have three groups; first by assigning the code to the groups, the groups will be determined(Group A: vibration bee with heat and Group B: vibration bee with cold and Group C: vibration bee with room temperature). 6 blocks with 3 pieces Characterized [(ABC(1)- ACB (2)-CAB (3)-BCA (4)- CBA (5)- BAC(6)]. Then, random numbers are selected between one to six (eg, 1, 4, 5, ...), and finally the list of treatment allocations based on random numbers will be determined. By drawing a lot, it will be clear what the sequence of doing the job is, Blinding description: The nurse who do this procedure(Intravenous Catheter Insertion) draws and either cools or warms the pack itself (in the intervention group) or at room temperature (in the control group):Therefore, the researcher will be blind when scoring on the relevant tool (for evaluation of the outcome) . Only the code for each child's tool will be written: so the statistical evaluator will be blind. N/A the pain induced with Peripheral venous catheter. Intervention 1: First Intervention group : Heat vibrating bee group: The vibrate bee puppet, which is attached to a warm bag with a local heat of 39-40 ° C below, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply. Intervention 2: Second Intervention group : Cool vibrating bee group: The vibrate bee puppet, which is attached to a cool bag with a local cold of 0 ° C below, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply. Intervention 3: Control group: vibrating bee group with room temperature : The vibrate bee puppet, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply. 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 No more information.
public maryam sahebkar moeini
plaque 559, between 39 and 41 Yousefzadeh Avenue, Khwaja Rabi Street
mashhad Iran (Islamic Republic of) 9149685674 +98 51 3742 0198 sahebkarmm961@mums.ac.ir Mashhad University of Medical Sciences scientific tahereh sadeghi
Faculty of Nursing and Midwifery, University Ave, Doctoral Crossroad, Ibn Sina St.
mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 sadeghit@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Child 3 to 6 years old with elective surgery Before entering the section or operating room, child need to Intravenous Catheter insertion At least one of the parents is present during Intravenous Catheter insertion The first experience of injection for child in this admission. The injection site is internal flexure of elbow or forearm and should not have a scar or skin problem The child has no sensory-neurological, vascular, hematologic, verbal and cognitive impairment and chronic illness Before intervention, the child is alert and has not received sleepy, sedative and narcotic drugs Before the intervention, the child's pain level is below three with the Wong-Baker FACES tool The child and parents have informed consent to participate in the intervention 3 years 6 years Both Dissatisfaction of parents and the child from the research Not successful first injection If the catheter insertion to the vein after it enter into the hand of child, it will take more than 20 seconds. R52.0 Treatment - Devices Treatment - Devices Treatment - Devices First Intervention group : Heat vibrating bee group: The vibrate bee puppet, which is attached to a warm bag with a local heat of 39-40 ° C below, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply. Second Intervention group : Cool vibrating bee group: The vibrate bee puppet, which is attached to a cool bag with a local cold of 0 ° C below, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply. Control group: vibrating bee group with room temperature : The vibrate bee puppet, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply. Pain caused by Peripheral Vein Catheter Insertion. Timepoint: Before and Immediately after Peripheral Vein Catheter Insertion. Method of measurement: Wong-Baker FACES. Mashhad University of Medical Sciences Approved 2019-06-13 Ethics committee of Mashhad University of Medical Sciences Mashhad School of Nursing and Midwifery, Ibn Sina Street, Doctoral intersection, University Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)