Investigating the effect of Educational Intervention based on the Ottawa Nutritional guide on Nausea and Vomiting in Pregnant women

Determining the effect of educational intervention based on the Ottawa nutritional guide on nausea and vomiting in pregnant women Specific goals.

Clinical trial with a control group, a blinded, randomized, on 60 patients. Random Allocation Software was used for randomization.

Random placement of pregnant women referring to women's clinics and specialized clinics of selected gynecologists in two groups. Blinding will only be done for the data analyst.

Entry: The gestational age should be 4-16 weeks (4 full weeks to 15 weeks and 7 days)، Singleton pregnancy، Mother's age should be 15-45 years، Be literate in reading and writing، Not suffering from a known physical or mental illness، Do not use drugs to reduce nausea and vomiting except vitamin B6، Score 3-16 in response to the Rhodes questionnaire، Body mass index is equal to or less than 30، Do not have hearing, speech or mental retardation، Do not smoke, use drugs or alcohol. Exit: Obstetrical problems may occur during the study، Vomiting that has a cause other than pregnancy، Being hospitalized due to severe nausea and vomiting of pregnancy.

The educational program will be presented during two 60-minute sessions in groups of two to five people of the Ottawa nutrition guide training with the methods of lectures, questions and answers, group discussions, lectures and slide shows. The educational content will include: the first session, general Ottawa guidelines for nausea and vomiting and the second session, other points will include lifestyle changes, complementary medicine, acupressure (practical finger acupressure training). During the study, the control group only received routine pregnancy training and did not receive any training from the researcher.

Average total score of nausea, vomiting and belching in pregnant women

The expected time for sampling was incorrectly entered.

Pregnant women will be included in the study if they are eligible based on the entry criteria and after obtaining written informed consent. Due to the fact that the subjects of the study do not enter the study at the same time, and the researchers cannot predict in advance which group each person who enters the study will belong to. To assigning the target group to one of the two study groups; The intervention group and the control group (two groups A and B) will use the Block Randomization method with ten blocks. Then the participants will be assigned to one of two groups 1 with a ratio of 1:1 according to the block randomization protocol (produced by Random Allocation Software), so that the researcher cannot predict which group the next person will be in. intervention will be placed. Randomization list based on software output: Allocation concealment In order to hide the random assignment, the codes created by the software will be placed in the envelope so that it is not clear which group the next person will be assigned to. Concealment of random allocation refers to the method used to perform a random sequence on the participants in the study, so that the assigned group is not known before the allocation of the individual. Without hiding the random sequence, there is a possibility of revealing the random sequence, which ultimately weakens the randomization process. Therefore, it is necessary for people who have the criteria to enter the research, a decision to accept or reject participation in the study should be made first and the informed consent form should be completed and then the participants will be assigned to each of the groups. Different methods can be used to hide random allocation. In this study, the method of opaque sealed envelopes with random sequence will be used. Based on the sample size of this research, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed.

In this study, considering that after randomization, the pregnant women themselves and the interventionist cannot be blinded (because the type of intervention is known). Completing questionnaires is also self-reported. Therefore, blinding cannot be done in the first stage. Blinding will only be done for the data analyst.