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IRCT20211211053351N1 IRCT 2022-01-02 Research Vice Chancellor of Mashhad University of Medical Science Effects of whistling compared with Buzzy device during blood sampling on pain and fear in children’s Effects of whistling compared with Buzzy device during blood sampling on pain and fear in children’s emergency department 2021-12-28 anticipated 120 Complete https://irct.ir/trial/60694 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 (group: vibrating bee / whistling / control) will be random; In this way, the assignment of samples to intervention groups (vibrating bee / whistling / control) 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 B: whistling C: control). 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. N/A Fear and pain caused by blood sampling. Intervention 1: Intervention group: Use vibrating bees with cold packs In this study, a musical doll in the shape of a bee with an approximate size of 15 cm with the ability to create vibration at the rate of 95-90 Hz was made, which is a portable cold bag with a linen cover in the form of a bracelet attached to it. When the child is with the parents, the nurse performing the blood sampling procedure, this musical bee doll, with the bag attached to it, is closed for 5 minutes, at a distance of about 5-10 cm above the blood sampling site, and in one minute The vibration end will be applied, then the child will enter the blood collection room with one of the parents and blood collection will be done immediately. Intervention 2: Intervention group: Use a bee-shaped whistle when drawing bloodو before entering the blood collection room, a bee-shaped balloon whistle with a long straw at the end will be given to the child and the child will be taught to die inside the straw 5 minutes before entering the room and whistle. Fill the air and the toy will be in the child's hand until the end of the blood collection and will continue to whistle during the blood collection process. Finally, the whistle will be given as a gift to the intervention group. Intervention 3: The third group of the control group will enter the blood collection room with one of their parents according to the routine blood sampling process in the emergency department of the child and sampling will be done. 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 Tahereh Sadeghi
School of Nursing and Midwifery, Ibn Sina St., Daneshgah St., Daneshgah St., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 1394491388 +98 51 3841 2081 sadeghit@mums.ac.ir Mashhad University of Medical Sciences scientific Tahereh Sadeghi
School of Nursing and Midwifery, Ibn Sina St., Daneshgah St., Daneshgah St., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 13944 91388 +98 51 3841 2081 sadeghit@mums.ac.ir Mashhad University of Medical Sciences Iraq The child needs blood sampling. At least one parent is present during blood sampling. Be the first child injection experience at this reception. The injection site of the inner crease of the elbow or forearm should be selected and there should be no scar or skin problem. The child does not have sensory-neurological, vascular, hematological, verbal and cognitive disorders and chronic diseases. • The child is awake before the intervention and has not received sedatives, sedatives or narcotics. Before the intervention, the child's pain level should be 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 children with research Failure to draw blood for the first time Treatment - Other Treatment - Other Treatment - Other Intervention group: Use vibrating bees with cold packs In this study, a musical doll in the shape of a bee with an approximate size of 15 cm with the ability to create vibration at the rate of 95-90 Hz was made, which is a portable cold bag with a linen cover in the form of a bracelet attached to it. When the child is with the parents, the nurse performing the blood sampling procedure, this musical bee doll, with the bag attached to it, is closed for 5 minutes, at a distance of about 5-10 cm above the blood sampling site, and in one minute The vibration end will be applied, then the child will enter the blood collection room with one of the parents and blood collection will be done immediately. Intervention group: Use a bee-shaped whistle when drawing bloodو before entering the blood collection room, a bee-shaped balloon whistle with a long straw at the end will be given to the child and the child will be taught to die inside the straw 5 minutes before entering the room and whistle. Fill the air and the toy will be in the child's hand until the end of the blood collection and will continue to whistle during the blood collection process. Finally, the whistle will be given as a gift to the intervention group. The third group of the control group will enter the blood collection room with one of their parents according to the routine blood sampling process in the emergency department of the child and sampling will be done. Pain caused by blood sampling. Timepoint: Before, during and after blood sampling. Method of measurement: Children's pain will be assessed using the Wong Baker Smile Scale. Fear caused by blood sampling. Timepoint: Before, during and after blood sampling. Method of measurement: Fear of blood sampling will be measured by the CMFS Children's Fear Scale. Research Vice Chancellor of Mashhad University of Medical Science Approved 2021-07-27 Ethics Committee of Mashhad University of Medical Sciences IbnSina 2St., School of Nursing and Midwifery, Khorasan Razavi, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)