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IRCT20131113015393N7 IRCT 2021-11-06 Sabzevar University of Medical Sciences Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain during venipuncture in children under chemotherapy 2021-10-27 anticipated 87 Complete https://irct.ir/trial/57748 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed using a computer-generated random list with permuted blocks of size eight, prepared by an independent statistician. Allocation was concealed using 88 sequentially numbered, opaque, sealed envelopes, opened at the time of assignment, Blinding description: This is a double-blind study. The participant (child and parent) is not aware of the injection method. The statistical analyzer will not know the injection method and the data will be provided to him in the form of codes A, B, C and D. N/A Condition 1: Acute pain. Condition 2: Fear. Intervention 1: In the present research, we will have 2 methods (2 intervention) for injection. The first method, using cold angiocatheter: venipuncture is performed by cooled angiocatheter kept at -20 °C freezer for at least one hour in a steel box. After identifying the target vein, the angiocatheter is immediate will be removed from the freezer and the venipuncture will be performed. The second method, using Xyla-p cream: venipuncture is done by rubbing 2.5 grams of Xyla-p cream on the 20-25 cm2 and covering it with nylon dressing for at least 45 minutes. This intervention of study will be conducted in 4 groups of participants. The maximum dose of the cream for a child, weighing more than 10 kg is 100 g of cream per 100 cm2 of the skin for 4 hours according to the available guidelines. Due to the dose used in this study, there is no possibility of complications such as skin allergies. Intervention group: The intervention in group 1 is that Xyla-p cream (first intervention) and cold angiocatheter (second intervention) are used. Intervention 2: Intervention group 2: The intervention is performed using Xyla-p cream (first intervention) and angiocatheter at room temperature (routine method). Intervention 3: Intervention group 3: This includes performing the intervention using moisturizing cream (placebo) and cold angiocatheter (intervention). Intervention 4: Control group: In this group, moisturizing cream (placebo) and angiocatheter are used at room temperature (routine method). 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 Fateme Borzoee
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 1000 borzoee75026@yahoo.com Sabzevar University of Medical Sciences scientific Fateme Borzoee
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 1000 borzoee75026@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Aged between 18 to 65 years Have leukemia Outpatients refer to the chemotherapy department Receive chemotherapy every week At least one month has passed since the onset of the disease 2 years 6 years Both Restless children The children with loss of consciousness Children receive sedative or analgesic Children with a history of sensitivity to lidocaine. G89.1 Acute pain, not elsewhere classified Treatment - Devices Treatment - Devices Treatment - Devices N/A In the present research, we will have 2 methods (2 intervention) for injection. The first method, using cold angiocatheter: venipuncture is performed by cooled angiocatheter kept at -20 °C freezer for at least one hour in a steel box. After identifying the target vein, the angiocatheter is immediate will be removed from the freezer and the venipuncture will be performed. The second method, using Xyla-p cream: venipuncture is done by rubbing 2.5 grams of Xyla-p cream on the 20-25 cm2 and covering it with nylon dressing for at least 45 minutes. This intervention of study will be conducted in 4 groups of participants. The maximum dose of the cream for a child, weighing more than 10 kg is 100 g of cream per 100 cm2 of the skin for 4 hours according to the available guidelines. Due to the dose used in this study, there is no possibility of complications such as skin allergies. Intervention group: The intervention in group 1 is that Xyla-p cream (first intervention) and cold angiocatheter (second intervention) are used. Intervention group 2: The intervention is performed using Xyla-p cream (first intervention) and angiocatheter at room temperature (routine method). Intervention group 3: This includes performing the intervention using moisturizing cream (placebo) and cold angiocatheter (intervention). Control group: In this group, moisturizing cream (placebo) and angiocatheter are used at room temperature (routine method). Pain. Timepoint: Before and during the intervention. Method of measurement: Flacc Scale. Fear. Timepoint: Before and during the intervention. Method of measurement: Children's Fear Scale. Sabzevar University of Medical Sciences Approved 2021-06-13 Ethics Committee of Sabzevar University of Medical Sciences Deputy of Research and Technology, Sabzevar University of Medical Sciences, SHohada Hastei Boulevard. Sabzevar Razavi Khorasan Iran (Islamic Republic of)