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IRCT20250611066177N1 IRCT 2025-07-22 Mashhad University of Medical Sciences Investigation of the Effect of Multisensory Tourniquet and Illustrated Tourniquet on Pain and Fear Associated with Intravenous Cannulation in Children Investigation of the Effect of Multisensory Tourniquet and Illustrated Tourniquet on Pain and Fear Associated with Intravenous Cannulation in Children Presenting to the Emergency Department 2025-09-23 anticipated 42 Complete https://irct.ir/trial/84258 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: In this study, the unit of randomization was the individual, meaning that each participant was independently assigned to either the intervention or control group. To ensure balance in the number of participants in each group throughout the allocation process, block randomization with fixed block sizes of six was employed. A total of seven six-person blocks were considered for the entire sample. The random allocation sequence within each block was generated using the Random Allocation Software. The sequence of group assignments (e.g., AABABB or ABABBA) was created entirely at random by the software. To ensure allocation concealment and minimize selection bias, the randomization process and assignment of participants to groups were carried out by an independent individual who was not part of the research team and had no knowledge of the group identities or study objectives. This approach ensured that group allocation was performed without researcher influence and in a fully blinded manner. N/A Investigation of the Effect of Multisensory Tourniquet and Illustrated Tourniquet on Pain and Fear Associated with Intravenous Cannulation in Children. Intervention 1: Intervention group: In the intervention group, a multi-sensory tourniquet shaped like a butterfly and approximately 10 centimeters in size, capable of producing vibrations at a frequency of 90-95 Hz, has been designed. Lights are embedded in the wings of this butterfly, and children's music will play. While the child is with the parents, the nurse performing the venipuncture will place this musical tourniquet on the child's arm before entering the procedure room, but will not tighten it. For 5 minutes, it will be applied approximately 5-10 centimeters above the injection site, and in the last minute, vibrations will be activated. Then, the child, accompanied by one of the parents, will enter the procedure room, the multi-sensory tourniquet will be tightened, and the venipuncture will be performed immediately on the same arm of the child. Intervention 2: Control group: In the control group, a patterned tourniquet with butterfly shapes will be placed on the child's arm for 5 minutes at a distance of 5 to 10 centimeters above the venipuncture site before entering the procedure room (it should be noted that the tourniquet will not be tightened before the venipuncture process begins). After entering the procedure room, the tourniquet will be tightened and fixed, and after completing the venous pathway opening process, the patterned tourniquet will be removed. 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 further information
public zahramirabi
Razavi Khorasan, Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex
mashhad Iran (Islamic Republic of) 9137913199 +98 51 3884 6730 nms.pr@mums.ac.ir Mashhad University of Medical Sciences scientific zahramirabi
University Boulevard, Baharestan Alley, No. 102
Neishabur Iran (Islamic Republic of) 9319613354 +98 51 4261 6788 zahramirabi58@gmail.c0m Mashhad University of Medical Sciences Iran (Islamic Republic of) Children aged 1 to 3 years The child needs to have an IV inserted At least one parent should be present during the blood draw. The injection site will be on the back of the hand or the inner crease of the elbow, and the area should be free of scars or skin issues Before the procedure, the child should be alert and should not have received any sedatives, tranquilizers, or narcotics. 1 year 3 years Both Parental dissatisfaction with the research First injection not successful If it takes more than 20 seconds to insert the angiocat into the vein after establishing the intravenous access in the child’s hand. Other Other Intervention group: In the intervention group, a multi-sensory tourniquet shaped like a butterfly and approximately 10 centimeters in size, capable of producing vibrations at a frequency of 90-95 Hz, has been designed. Lights are embedded in the wings of this butterfly, and children's music will play. While the child is with the parents, the nurse performing the venipuncture will place this musical tourniquet on the child's arm before entering the procedure room, but will not tighten it. For 5 minutes, it will be applied approximately 5-10 centimeters above the injection site, and in the last minute, vibrations will be activated. Then, the child, accompanied by one of the parents, will enter the procedure room, the multi-sensory tourniquet will be tightened, and the venipuncture will be performed immediately on the same arm of the child. Control group: In the control group, a patterned tourniquet with butterfly shapes will be placed on the child's arm for 5 minutes at a distance of 5 to 10 centimeters above the venipuncture site before entering the procedure room (it should be noted that the tourniquet will not be tightened before the venipuncture process begins). After entering the procedure room, the tourniquet will be tightened and fixed, and after completing the venous pathway opening process, the patterned tourniquet will be removed. Fear of opening an IV line. Timepoint: After the intervention begins. Method of measurement: Using the CMFS (Child Medical Fear Scale) questionnaire. Pain caused by opening a venous pathway. Timepoint: Immediately after opening the venous pathway. Method of measurement: Using the FLACC behavioral response scale(Face, Legs, Activity, Cry, Consolability). Mashhad University of Medical Sciences Approved 2025-05-20 Mashhad University of Medical Sciences Razavi Khorasan, Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex mashhad Razavi Khorasan Iran (Islamic Republic of)