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IRCT20210317050732N1 IRCT 2021-05-15 Islamic Azad University The effect of topical application of black seed oil on the prevention of bedsores The effect of topical application of black seed oil on the prevention of bedsores in patients admitted to the intensive care unit 2021-05-20 anticipated 72 Complete https://irct.ir/trial/55110 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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. N/A Bedsore. Intervention 1: Intervention group: in addition to the wavy mattress and change Positions every two hours, 1-3 cc of the black seed oil(With a concentration of 100% made in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences in Good laboratory Practice=GLP) is rubbed on the Susceptible areas of bed sores for 7 days. Intervention 2: Control group: In this group, only the wavy mattress and change Positions every two hours will be used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Azam Maboudi
Islamic Azad University Medical Sciences of Tehran, Khaghani street, Shariati Street
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 6660 maboodiazam@gmail.com Islamic Azad University scientific Zohreh Parsayekta
Islamic Azad University Medical Sciences of Tehran, Khaghani street, Shariati Street
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 6660 Zparsa@tums.ac.ir Islamic Azad University Iran (Islamic Republic of) Patients admitted to the intensive care unit Stable hemodynamic status Not participating in similar research projects in the last six months Being between 18 and 75 years old 18 years 75 years Both Having bedsore having diabetes Allergy to black seed oil L89 Pressure ulcer Prevention N/A Intervention group: in addition to the wavy mattress and change Positions every two hours, 1-3 cc of the black seed oil(With a concentration of 100% made in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences in Good laboratory Practice=GLP) 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. Bedsore. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: The Braden Scale for Predicting Pressure Ulcer Risk. Islamic Azad University Approved 2021-03-15 Ethics committee of Tehran Islamic Azad University of Medical Sciences Islamic Azad University Medical Sciences of Tehran, Khaghani street, Shariati Street Tehran Tehran Iran (Islamic Republic of)