The effect of topical application of black seed oil on the prevention of bedsores in patients admitted to the intensive care unit

Determining the effect of topical application of black seed oil on the prevention of bedsores in patients admitted to the ICU

A clinical trial with a control group, parallel, not blinded, randomized, on 72 patients who were selected by available methods and Will be allocated into two groups of intervention and control by the Block randomization method. by Using non-transparent envelopes sealed with random sequences that the lids of the letter envelopes are glued and placed inside a box, respectively. based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.

Patients admitted to the intensive care unit of Imam Sadegh (AS) Hospital in Hashtgerd are selected by available methods and are randomly divided into two groups. For the control group, only the wavy mattress and changing the position will be used every two hours. But for the intervention group, in addition to the wavy mattress and changing the position every two hours, daily, 1-3 cc of the black seed oil is rubbed on the prone areas of bed sores for 7 days, then the results are compared in the two groups.

Inclusion criteria include patients, Being between 18 and 75 years old, Not participating in similar research projects in the last six months, and Stable hemodynamic status. Non-entry conditions include bedsores, diabetes, and a history of allergy to black seed oil.

Intervention group: In this group, in addition to the wavy mattress and change Positions every two hours, 1-3 cc of the black seed oil is rubbed on the Susceptible areas of bed sores for 7 days. Control group: In this group, only the wavy mattress and change Positions every two hours will be used.

bedsores

The sampling method will initially be available; The samples will then be placed in quadruple blocks by block random sampling. The blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment, we will have 4 blocks (including 2 participants in the intervention group and 3 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.