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IRCT20100829004655N12 IRCT 2023-05-04 Kashan University of Medical Sciences Comparison of the effects of acupressure points on patients undergoing chemotherapy Comparison of the effects of acupressure points (P6, K-K9) on Nausea, Vomiting and anxiety of patients undergoing chemotherapy 2023-05-22 anticipated 90 Complete https://irct.ir/trial/69884 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Demographic information obtained includes first and last name, date of injection, age, gender, marital status, economic status, occupation, education, type of insurance, family history of cancer, alcohol consumption, and smoking and tobacco use. The obtained clinical information, which is completed by the patient or by referring to the medical record, also includes diagnosis, stage of the disease, duration of the disease, the number of cycles of chemotherapy, the method of receiving chemotherapy, the name and dosage of chemotherapy drugs. Treatment is the degree of nausea of the drugs, the name of the anti-nausea drugs and the dose received in the hospital and at home, the name of other drugs used, body mass index, history of surgery related to cancer, and other complications related to chemotherapy. If the patient needs help to complete the questionnaires, they will be completed by the researcher in the hospital.The drugs used as anti-nausea in these patients will be 4mg ondansetron ampoule, 8mg dexamethasone ampoule, and Aprepitant oral capsule. It should be noted that during the study, each patient's chemotherapy and anti-nausea regimen will not change. The use of drugs to relieve nausea other than the mentioned drugs, if used in the hospital by the researcher and if used at home by the patient and in a checklist that we provide to him, will be registered.The exact location of acupressure points is taught to the patient by the researcher, and for this purpose, a pamphlet is also given to her to help her find the point at home, Randomization description: After reviewing the entry criteria (referring to the medical record and interviewing the individual), patients who are eligible to enter the study are randomly grouped. Each patient is placed in one of the groups P6, K-K9 and Li5 (placebo) according to the nausea-inducing level of chemotherapy drugs (low, medium and high). It should be noted that according to the table of nausea-inducing drugs, 4 general categories are considered for chemotherapy drugs, which include Minimal Risk of Emesis, Low Risk of Emesis, Moderate Risk of Emesis, and High Risk of Emesis. The minimal risk of emesis category is not included in the study. For example, the first qualified referral patient is treated with a three-drug regimen of 5FU (Fluorouracil), oxaliplatin and docetaxel; According to the table, these drugs are mild, moderate nauseating, and low nauseating. Due to the presence of a drug with moderate nausea (oxaliplatin), this patient is considered out of this category (moderate nausea). Referring to the blocks, this person is placed in group B, the same as K-K9. If the next person is considered part of the moderate nausea group, he will be placed in group A, the same group as P6. In the same way, the following people are assigned to three groups, P6, K-K9, and Li5, according to whether the amount of nausea caused by their drugs is low, medium, or high. Allocation of groups is done randomly using the stratified method based on the degree of nausea of the drugs and using the Sealedenvelope.com site. In this method, the size of the blocks is considered to be 6. The size of the list is considered to be 126 due to the equal distribution of each class among the three groups. In fact, by increasing the list size, samples from other classes can be included in the study if a class does not reach the quorum, Blinding description: Due to the interventions' observable nature, it is impossible to design the study in a completely blind manner. In this study, after giving informed consent to participate in the research, the participants will not know whether they are in the placebo group or the main groups, so the main names of the points are not told to the participants. Instead, general names such as A, B, and C are used. As a research team member, the nursing master's student is responsible for implementing interventions and collecting questionnaires and checklists, so there is no possibility of blinding in this case. The healthcare workers in the special injection ward of Shahid Beheshti Hospital in Kashan (including nurses) also do not know about the real intervention. N/A chemotherapy. Intervention 1: The first intervention group: pressure on the P6 point will be applied bilaterally by acupressure wrist straps. The wristbands are from the vomit-band brand and consist of a webbing with a button in the middle that puts pressure on the P6 point. Acupressure intervention will be done before chemotherapy until five days after. The patient is asked to remove the acupressure tools at the end of the day and before going to sleep and complete the special checklists designed for this study. The next day, he should use that tool again in the same place. This process should be done five days after the injection. It should be noted that he can remove them from his hands during bathing, washing hands, etc. After five days, the patient does not need to do anything else. Intervention 2: The second intervention group: Applying pressure on the K-K9 point is done bilaterally by rings made of knitted fabric with a button in the middle (similar to the button of P6 wristbands). Acupressure intervention will be done before chemotherapy until five days after. The patient is asked to remove the acupressure tools at the end of the day and before going to sleep and complete the special checklists designed for this study. The next day, he should use that tool again in the same place. This process should be done five days after the injection. It should be noted that he can remove them from his hands during bathing, washing hands, etc. After five days, the patient does not need to do anything else. Intervention 3: Control group: Applying pressure on the Li5 point (placebo) using knitted wristbands, which apply pressure on the desired point bilaterally. The button that puts pressure on this point is similar to that on P6 wristbands. Acupressure intervention will be done before chemotherapy until five days after. The patient is asked to remove the acupressure tools at the end of the day and before going to sleep and complete the special checklists designed for this study. The next day, he should use that tool again in the same place. This process should be done five days after the injection. It should be noted that he can remove them from his hands during bathing, washing hands, etc. After five days, the patient does not need to do anything else. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: Start the access period 6 months after printing the results To whom: Only available to scholars working in academia and academia. Conditions: If you observe the trust and mention the source, data is available for researchers Where to obtain: Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir How to obtain: After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion. Comments:
public Mohsen Taghadosi
Ravandi Ghotb Blvd
Kashan Iran (Islamic Republic of) 87159/81151 +98 31 5554 0021 taghadosi_m@kaums.ac.ir Kashan University of Medical Sciences scientific Mohsen Taghadosi
Ravandi Ghotb Blvd
Kashan Iran (Islamic Republic of) 87159/81151 +98 31 5554 0021 taghadosi_m@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients 16 years and older Patients with a definitive diagnosis of breast, colorectal, lung, prostate, and ovarian cancers by a specialist doctor Patients who mention having nausea in their previous chemotherapy period Patients who receive chemotherapy drugs by intravenous, port, or intravenous injection along with oral intake Patients who have received at least one cycle of chemotherapy 16 years no limit Both Undergoing radiotherapy at the same time as chemotherapy Using other complementary treatments at the same time Having a known anxiety disorder Having problems in the skin of acupressure points (for example, edema, lesions, or skin wounds) so that effective pressure cannot be applied Having problems such as gastrointestinal diseases with nausea and vomiting, migraines, and tinnitus that are related to before the start of chemotherapy and interfere with nausea and vomiting of chemotherapy. This case will be reviewed based on the patient's statement or medical record Patients who have a minimal risk of emesis chemotherapy regimen as determined by a specialist doctor. Z54.2 Convalescence following chemotherapy Prevention Prevention Placebo The first intervention group: pressure on the P6 point will be applied bilaterally by acupressure wrist straps. The wristbands are from the vomit-band brand and consist of a webbing with a button in the middle that puts pressure on the P6 point. Acupressure intervention will be done before chemotherapy until five days after. The patient is asked to remove the acupressure tools at the end of the day and before going to sleep and complete the special checklists designed for this study. The next day, he should use that tool again in the same place. This process should be done five days after the injection. It should be noted that he can remove them from his hands during bathing, washing hands, etc. After five days, the patient does not need to do anything else. The second intervention group: Applying pressure on the K-K9 point is done bilaterally by rings made of knitted fabric with a button in the middle (similar to the button of P6 wristbands). Acupressure intervention will be done before chemotherapy until five days after. The patient is asked to remove the acupressure tools at the end of the day and before going to sleep and complete the special checklists designed for this study. The next day, he should use that tool again in the same place. This process should be done five days after the injection. It should be noted that he can remove them from his hands during bathing, washing hands, etc. After five days, the patient does not need to do anything else. Control group: Applying pressure on the Li5 point (placebo) using knitted wristbands, which apply pressure on the desired point bilaterally. The button that puts pressure on this point is similar to that on P6 wristbands. Acupressure intervention will be done before chemotherapy until five days after. The patient is asked to remove the acupressure tools at the end of the day and before going to sleep and complete the special checklists designed for this study. The next day, he should use that tool again in the same place. This process should be done five days after the injection. It should be noted that he can remove them from his hands during bathing, washing hands, etc. After five days, the patient does not need to do anything else. Nausea, whose score is measured by the Rhodes Nausea and Vomiting Questionnaire (statements 4, 5, and 7). Timepoint: One hour after chemotherapy and at the end of the first to fifth days of chemotherapy. Method of measurement: The Rhodes Nausea and Vomiting Questionnaire. Vomiting, whose score is measured by the Rhodes Nausea and Vomiting Questionnaire (statements 1, 3, and 6). Timepoint: One hour after chemotherapy and at the end of the first to fifth days of chemotherapy. Method of measurement: The Rhodes Nausea and Vomiting Questionnaire. Anxiety is measured by Spielberger's state-trait anxiety questionnaire. Timepoint: One hour after chemotherapy and at the end of the first to fifth days of chemotherapy. Method of measurement: The Spielberger's state-trait anxiety questionnaire. Kashan University of Medical Sciences Approved 2023-04-09 Research Ethics committees of Faculty of Medicine and Faculty of Dentistry- Kashan University of Med Ghotb Ravandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)