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IRCT20211213053389N2 IRCT 2024-10-24 Kerman University of Medical Sciences Investigating the effect of auricular acupressure on pain, quality of life and peripheral neuropathy caused by chemotherapy Investigating the effect of auricular acupressure on pain, quality of life and peripheral neuropathy caused by chemotherapy among the elderly with breast cancer referred to centers affiliated to Kerman University of Medical Sciences 2024-10-12 anticipated 60 Complete https://irct.ir/trial/79465 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be selected by continuous sampling, and patients will be divided into control and test groups by Block Balanced Randomization (BBR). The allocation sequence will be done using the free web system http://www.randomization.com/. In this way, the number of subjects in each block is determined by 4 people and the letter A will be considered for the control group and the letter B will be considered for the experimental group. The assignment sequence will be created for 60 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, the Allocation Concealment will be considered and observed. Based on the eligible samples, an envelope shuffling envelope will be randomly removed by the researcher, and the method of randomly assigning the research samples will be determined, Blinding description: Because Vacaria seeds are placed by the researcher on different points on the ear in both the control and intervention groups, and the participants are blind about which group they are in, and the elderly participants will not be informed which intervention group they are in. or are in control. On the other hand, the participants do not know the location of the reflective points of the intervention, it is expected that there will be no interference between the participants of the two control and intervention groups. However, the participants of the intervention group are informed not to pass on the information about the reflective points on the ear to other participants. In this study, the participants and the statistician for data analysis are blinded to the members of each group. N/A Breast Cancer. Intervention 1: Intervention group: In the intervention group, auricular acupressure will be applied on 3 common ear points, including the spleen, liver, and spleen, and 1 point related to the finger or toe points will be added, based on each participant's understanding of the severity of the symptoms in the specific hand or foot location. will be selected. As a main point, Shenman is widely used in sick and healthy populations to treat physical and mental problems. Stimulating both liver and spleen points increases metabolism because these points play a role in reducing the neurotoxic effects of chemotherapy. Because direct pressure on the reflex points of the symptomatic parts of the body on the ear helps to relieve the pain level, 1 point out of 2 points, i.e. finger or toe point, will be selected for use in the intervention group. Vacaria plant has small black seeds, which are used in ear acupressure due to the hardness of the seeds to apply pressure on specific points on the ear, and Vacaria plant seeds also have anti-inflammatory properties in ear acupressure. Vaccaria seeds will be used for proper and long-term stimulation, which is widely used and will be placed bilaterally at target points on both ears at the same time. Considering the possible benefits and risks, the ear acupressure intervention will be performed for three weeks, and we stick the herbal seeds on the ear every week for the first 5 days, and then rest for 2 days, and then remove the herbal seeds. And thus, the patient will undergo acupressure for three consecutive weeks. Due to the long-term use of adhesive tapes, the ear points are rested before replacing new beads to avoid side effects such as contact dermatitis. The elderly were instructed to press each ear point for 2 minutes (1 second per pressure) at least 3 times a day, for 5 consecutive days. Pressure levels will be adjusted depending on the tolerance of the elderly. First, the designated points on the patient's ear are cleaned with 70% alcohol, and then adhesives with Vacaria plant seeds (0.5 x 0.5 cm) will be used to apply continuous pressure on the ear throughout the day and night, and the adhesive will be used. The plant seeds will be removed from the ear after five days, and if the plant seed paste is removed from the ear earlier than five days, the elderly will be asked to inform immediately so that the researcher can use the paste with new plant seeds again to apply continuous pressure. Participants who did not pay attention to the instructions in keeping plant seeds in specific places, which led to a decrease in the received dose (more than 10% of the intervention period or more than one day of the intervention period, plant seeds were removed from the ear will be excluded from the study. Intervention 2: Control group: In the control group, to clearly determine the effectiveness of ear acupressure to reduce bias and create blinding between the participants, Vacaria plant seeds were placed on different ear points, including teeth, tongue, jaw, and inner ear, which will be located at a distance from the ear points in the intervention group. These points are not related to CIPN. 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 program has been developed to provide the data yet.
public Mohammad hossein Khajehpour
Razi School of Nursing and Midwifery, University of Medical Sciences campus, At the beginning of Haft Bagh Alavi axis, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 Khajehpoor_m@yahoo.com Kerman University of Medical Sciences scientific Batool Tirgari
Razi School of Nursing and Midwifery, University of Medical Sciences campus, At the beginning of Haft Bagh Alavi axis, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 batool.tirgary@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Undergoing chemotherapy, including taxane agents (such as docetaxel and paclitaxel) Elderly over 65 years old Reported a score greater than five on a numerical rating scale for pain symptoms in the past week (indicating more severe than average pain) Possibility to participate in the plan for four weeks The ability to communicate and the absence of speech and hearing problems 65 years no limit Both 12 months or more have passed since the end of their chemotherapy treatment They had skin inflammation, or used hearing aids, or had piercings or holes in the intervention sites During the study period, they are under chemotherapy or radiotherapy Ear acupressure experience within 3 months before participating in the study Metastatic cancer status Have psychiatric diseases or other diseases that can affect this study (Alzheimer's, delirium, rheumatoid arthritis) C50 Malignant neoplasm of breast Prevention Prevention Intervention group: In the intervention group, auricular acupressure will be applied on 3 common ear points, including the spleen, liver, and spleen, and 1 point related to the finger or toe points will be added, based on each participant's understanding of the severity of the symptoms in the specific hand or foot location. will be selected. As a main point, Shenman is widely used in sick and healthy populations to treat physical and mental problems. Stimulating both liver and spleen points increases metabolism because these points play a role in reducing the neurotoxic effects of chemotherapy. Because direct pressure on the reflex points of the symptomatic parts of the body on the ear helps to relieve the pain level, 1 point out of 2 points, i.e. finger or toe point, will be selected for use in the intervention group. Vacaria plant has small black seeds, which are used in ear acupressure due to the hardness of the seeds to apply pressure on specific points on the ear, and Vacaria plant seeds also have anti-inflammatory properties in ear acupressure. Vaccaria seeds will be used for proper and long-term stimulation, which is widely used and will be placed bilaterally at target points on both ears at the same time. Considering the possible benefits and risks, the ear acupressure intervention will be performed for three weeks, and we stick the herbal seeds on the ear every week for the first 5 days, and then rest for 2 days, and then remove the herbal seeds. And thus, the patient will undergo acupressure for three consecutive weeks. Due to the long-term use of adhesive tapes, the ear points are rested before replacing new beads to avoid side effects such as contact dermatitis. The elderly were instructed to press each ear point for 2 minutes (1 second per pressure) at least 3 times a day, for 5 consecutive days. Pressure levels will be adjusted depending on the tolerance of the elderly. First, the designated points on the patient's ear are cleaned with 70% alcohol, and then adhesives with Vacaria plant seeds (0.5 x 0.5 cm) will be used to apply continuous pressure on the ear throughout the day and night, and the adhesive will be used. The plant seeds will be removed from the ear after five days, and if the plant seed paste is removed from the ear earlier than five days, the elderly will be asked to inform immediately so that the researcher can use the paste with new plant seeds again to apply continuous pressure. Participants who did not pay attention to the instructions in keeping plant seeds in specific places, which led to a decrease in the received dose (more than 10% of the intervention period or more than one day of the intervention period, plant seeds were removed from the ear will be excluded from the study. Control group: In the control group, to clearly determine the effectiveness of ear acupressure to reduce bias and create blinding between the participants, Vacaria plant seeds were placed on different ear points, including teeth, tongue, jaw, and inner ear, which will be located at a distance from the ear points in the intervention group. These points are not related to CIPN. Chemotherapy-induced peripheral neuropathy score in Chemotherapy-Induced Peripheral Neuropathy-20 (CIPN-20), health-related quality of life score in Functional Assessment of Cancer Therapy-General (FACT-G), pain score in The Numeric Rating Scale. Timepoint: Questionnaires are given to the participants before the intervention, immediately after the end of the intervention and two weeks after the end of the intervention, or they are completed with an interview. Method of measurement: Chemotherapy-Induced Peripheral Neuropathy-20 questionnaires (CIPN-20), Functional Assessment of Cancer Therapy-General questionnaires (FACT-G), The Numeric Rating Scale. Kerman University of Medical Sciences Approved 2024-10-09 Ethics committee of Kerman University of Medical Sciences Beginning of Ibn Sina Street, first Jihad Blvd., Somayeh intersection, Kerman Kerman Kerman Iran (Islamic Republic of)