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.
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.