Investigating the Effect of Oral Probiotic Capsules on Postpartum Quality of Life in Primiparous women

Determining the effect of oral probiotic capsule on the quality of life after delivery of primiparous women

A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 60 samples. Randomization with r software

After obtaining written consent, in the first stage, non-probability sampling will be available, in the second stage, how to assign people to two groups (intervention group of 30 people and the second group of 30 people) randomly and using the method Blocking will be done with 15 blocks of 4 blocks.

The inclusion criteria include Iranians living in Mashhad, first-born, age 18-35 years, living with a spouse, no current illness and no history of depression and mental illnesses during pregnancy, a score of "less than severe" from the DASS21 questionnaire in the depression and anxiety subscale and Stress, no chronic disease, no smoking and alcohol, singleton pregnancy, birth of a healthy and mature baby weighing 2500 to 4000 grams, no use of probiotics from 2 weeks before the start of the intervention, low-risk pregnancy and uncomplicated delivery, vaginal delivery. The exclusion criteria include the mother's reluctance to continue participating in the study, the occurrence of unfortunate events in the last three months, failure to breastfeed the baby, suffering from complications after childbirth, the baby suffering from jaundice and any other problems, death of the baby.

will take one Bioflora probiotic capsule from Tekgen Bio company containing Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium longum daily from the fifth day after delivery to four weeks after receiving the medicine, and the control group will receive a placebo containing Avicel powder.

life quality

The method of assigning people to two groups (the intervention group of 30 people and the second group of 30 people) will be randomly and using the block method with blocks of 4 and 15 blocks of 4 will be done. Randomization according to the previously randomized list will be done by the statistics consultant using the random number table or R software and will be given to the researcher. Considering that the block size is 4, we will have 6 different combinations of 2 intervention groups, which we enter in the block variable. In the next step, we take a random sample of 15 of these combinations. To complete our randomization list. Commands in R are shown: bloks<-c("AABB","ABAB","ABBA","BABA","BABA","BBAA") n=15 list<-sample(bloks,n,replace=TRUE) list "AABB" "BABA" "BABA" "BABA" "ABAB" "BBAA" "AABB" "BABA" "BBAA" "BABA" "ABBA" "ABAB" "BBAA" "BABA" "ABAB" The method of assigning people to two groups will be randomly and using the block method with blocks of 4. For concealment, we use concealment allocation in such a way that the assigned group is not known before assigning the individual. By using non-transparent and closed envelopes with a random sequence of envelopes opaque, sealed, numbered sequentially (in this method, 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 the random sequence, the outer surface of the envelopes is numbered in the same order. The lids of the envelopes are glued and placed in a box respectively. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

People in the placebo group will receive a capsule with the same smell, color, shape and size as the medicine capsule of the test group. In order to eliminate the bias caused by the awareness of the patient or the researcher, the study was conducted in a double-blind manner.