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IRCT20110122005663N2 IRCT 2021-11-09 Rasht University of Medical Sciences Comparison the effect of acupressure and massage with ice on Hugo’s point on pain and Physiological parameters related to chemotherapy drug injection in children with acute lymphoblastic leukemia, clinical trial Comparison the effect of acupressure and massage with ice on Hugo’s point on pain and Physiological parameters related to chemotherapy drug injection in children with acute lymphoblastic leukemia, clinical trial 2021-11-26 anticipated 52 Complete https://irct.ir/trial/59809 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Other design features: The study method has two implementation phases. In the first phase, for group A, ice massage is performed at Hugo point and for group B, acupressure. Then, after a month of cleansing period, in the second phase, for group A, acupressure and for group B, ice massage is performed. The study is a crossover clinical trial, Randomization description: Four random blocks will be used for random assignment of samples to two groups of ice massage at Hugo point (group A) and acupressure (group B). The number of blocks required in this study is 13 blocks, based on which random allocation will be done. The sequence of random assignment of samples to two groups of ice massage at Hugo point (group A) and acupressure (group B) is determined through Random allocation online software. The sequence list of samples A and B will be kept in a sealed envelope in the nursing office of 17 Shahrivar Hospital in Rasht. After starting the study, it will be opened by the main researcher and based on gradual referrals, children in one of groups A or B Will be located and will continue until the estimated sample size in each group is reached, Blinding description: In order to blind the researcher and prevent the effect of mentality on the research results, acupressure and ice massage at Hugo point will be done by one of the members of the research team (main researcher) and the measurement of pain and physiological indicators will be done by the researcher. N/A Acute lymphoblastic leukemia. Intervention 1: Intervention group: In the first phase of the operation, in the intervention group, ice massage at the Hugo point is performed 5 minutes before the injection of chemotherapy by the main researcher for the child. To start the massage, first the child is placed on his back in a calm, comfortable and lying position. To determine the Hugo point, place the child's thumb in the abduction position, in which case, a prominent muscular peak (corresponding to the muscle approaching the thumb) located in the middle of the angle between the first and second bones of the palm, between the thumb and the finger. The point is on the back of the hand, the point is Hugo. Then place the hand Hugo point where the injection is not done, for one minute using a piece of ice (2 cm in diameter) wrapped in plastic gloves and a single layer of cotton cloth, using the soft part of the thumb in a rotating manner. , Press in a clockwise direction with an average pressure of 3 to 4 kg, so that the maximum pressure time is cut off one minute at a time and then 10 seconds, and lasts for a total of 5 minutes. Then, after one month and in the second phase of the implementation, acupressure intervention will be performed for this group. Intervention 2: Control group: In the first phase, in the control group, Hugo point acupressure is performed by the principal investigator for the child 5 minutes before the chemotherapy drug is injected. To start work, first the child is placed on his back in a calm, comfortable and lying position. To determine the Hugo point, place the child's thumb in the abduction position, in which case, a prominent muscular peak (corresponding to the muscle approaching the thumb) located in the middle of the angle between the first and second bones of the palm, between the thumb and the finger. The point is on the back of the hand, the point is Hugo. Then press the hand Hugo point where the injection is not done, with the thumb, in a clockwise direction, with a deep pressure of 3 to 4 kg, so that the maximum pressure time per time The pressure is turned off for one minute and then for 10 seconds and lasts for a total of 5 minutes. After a month and in the second phase of the performance, an ice massage intervention will be performed at Hugo Point for this group. 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 After sampling and completion of the project implementation phase, a decision will be made.
public Mahshid Mirzaei Taklimi
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo Street, Beheshti Highway
Rasht Iran (Islamic Republic of) 4146939841 +98 13 3355 5056 mahshidmirzaie2015@gmail.com Rasht University of Medical Sciences scientific Mahshid Mirzaei Taklimi
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo Street, Beheshti Highway
Rasht Iran (Islamic Republic of) 4146939841 +98 13 3355 5056 mahshidmirzaie2015@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Children aged 3-12 years With acute lymphoblastic leukemia One month has passed since the diagnosis Treated with Vincristine Chemotherapy Do not use the catheter port to prescribe chemotherapy No genetic or mental illness Organ health at the massage point Not receiving acupressure and ice massage at Hugo Point before the study Do not take painkillers 8 hours before chemotherapy injection 3 years 12 years Both Reluctance to collaborate in the study Inadequate and severe mental and physical conditions C91.0 Acute lymphoblastic leukemia [ALL] Other Other Intervention group: In the first phase of the operation, in the intervention group, ice massage at the Hugo point is performed 5 minutes before the injection of chemotherapy by the main researcher for the child. To start the massage, first the child is placed on his back in a calm, comfortable and lying position. To determine the Hugo point, place the child's thumb in the abduction position, in which case, a prominent muscular peak (corresponding to the muscle approaching the thumb) located in the middle of the angle between the first and second bones of the palm, between the thumb and the finger. The point is on the back of the hand, the point is Hugo. Then place the hand Hugo point where the injection is not done, for one minute using a piece of ice (2 cm in diameter) wrapped in plastic gloves and a single layer of cotton cloth, using the soft part of the thumb in a rotating manner. , Press in a clockwise direction with an average pressure of 3 to 4 kg, so that the maximum pressure time is cut off one minute at a time and then 10 seconds, and lasts for a total of 5 minutes. Then, after one month and in the second phase of the implementation, acupressure intervention will be performed for this group. Control group: In the first phase, in the control group, Hugo point acupressure is performed by the principal investigator for the child 5 minutes before the chemotherapy drug is injected. To start work, first the child is placed on his back in a calm, comfortable and lying position. To determine the Hugo point, place the child's thumb in the abduction position, in which case, a prominent muscular peak (corresponding to the muscle approaching the thumb) located in the middle of the angle between the first and second bones of the palm, between the thumb and the finger. The point is on the back of the hand, the point is Hugo. Then press the hand Hugo point where the injection is not done, with the thumb, in a clockwise direction, with a deep pressure of 3 to 4 kg, so that the maximum pressure time per time The pressure is turned off for one minute and then for 10 seconds and lasts for a total of 5 minutes. After a month and in the second phase of the performance, an ice massage intervention will be performed at Hugo Point for this group. Score of pain due to chemotherapy injection. Timepoint: Before the intervention, 5 seconds before the injection and 15 seconds after the injection of chemotherapy. Method of measurement: Oucher's pain intensity self-measurement scale. Percentage of arterial blood oxygen saturation. Timepoint: Before the intervention, 5 seconds before the injection and 15 seconds after the injection of chemotherapy. Method of measurement: Pulse oximeter device. Heart rate(pulse). Timepoint: Before the intervention, 5 seconds before the injection and 15 seconds after the injection of chemotherapy. Method of measurement: Pulse oximeter device. Rasht University of Medical Sciences Approved 2021-10-27 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for Research and Technology of Guilan University of Medical Sciences, in front of 17 Shahrivar hospital, Shahid Siadati Street, Namjoo Street. Rasht Guilan Iran (Islamic Republic of)