Investigating the effect of apricot kernel oil cream on pain intensity and episiotomy wound healing in primiparous women

Investigating the effect of apricot kernel oil cream on pain intensity and episiotomy wound healing in primiparous women

A clinical trial with two intervention and placebo groups with parallel groups, triple blind, randomized, phase 2-3 for 76 patients. Random Allocation Software will be used for randomization.

This triple-blind research will be conducted in M. Al-Binin (S) and Hashminejad hospitals in Mashhad. In the intervention group, they will use apricot kernel oil cream every 12 hours for 10 nights. The placebo group will also use the placebo in the same way. The tools will include a demographic and midwifery information questionnaire, a visual pain scale, a Rida scale form and a drug side effects form, which will be evaluated within the first 24 hours after delivery, on the fifth day and one of the days during 10 to 14 it will take place after childbirth.

Inclusion criteria: signed informed consent; no use of drugs effective on wound healing; no diabetes. Exclusion criteria: abnormal bleeding after delivery; not using the cream regularly; not coming for follow-up; suffering from a disease that requires the prescription of antibiotics.

The intervention group consumes 30 grams of apricot kernel oil cream tubes prepared with code A or B, topically and every 12 hours, 2 cm of the product in the first 10 days after delivery. in the control group. The placebo is a standard cold cream without apricot kernel oil and as a simple cream base, which is similar to the drug in terms of shape and can only be distinguished by the code, and the method of administration will be the same as the drug group.

Intensity of episiotomy pain; healing of episiotomy wound

Blocked random assignment In this study, permutation blocks method will be used to generate the sequence of random assignment of people to the studied groups. Random allocation sequence of people will be done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups. In this study, there are six blocks AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5) and BAAB (6). One of the blocks is randomly selected. If the first block, AABB, is selected, the first and second people are assigned to group A, and the third and fourth people are assigned to group B, and this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers. Allocation Concealment method Random Allocation Software Sealed envelopes are used to hide the assignment. Based on the order of entry of the research units, the envelopes will be opened in order and the assigned group will be revealed. In order to hide the allocation, opaque envelopes numbered consecutively (in the order of allocation sequence) were used, which will contain 2 bottles containing the solution. Medicines will be placed in the envelopes based on the random sequence of allocation by a person not involved in the research. Entering people into the study and delivering the envelopes from number 1 to 120 will be done by the researcher himself

The drug and placebo are blinded by the pharmacist and the researcher and the participants will not know the contents of the package. The desired cream is prepared in containers of one shape and one color of 30 grams, and coding (A, B) will be done on the containers by a pharmacist consultant. 38 participants in each group will receive cream A or B randomly.