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IRCT20220110053683N1 IRCT 2022-04-05 Vice Chancellor for Research and Technology of Arak University of Medical Sciences Comparison of the effect of olive oil and sesame oil on prevention of pressure ulcer Comparison of the effect of olive oil and sesame oil on the prevention of pressure ulcers in ICU patients. 2022-04-09 anticipated 60 Complete https://irct.ir/trial/61205 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In simple random sampling, each element of the target community has an equal chance of being selected. In this method, the required persons or objects are randomly selected from the list of statistical population that has been numbered and prepared for this purpose. In our study, the random number table method will be used and we will move from right to left horizontally. We will place odd numbers in intervention group 1 and even numbers in intervention group 2, then start by entering each of the samples with the conditions for inclusion in the study, Blinding description: In this study, the nurse - the person analyzing the statistical data - the patient himself will be blinded. To blind the nurse, two groups of glass containers (a - b) of the same color are used for which olive and sesame oil are inseparable. Also, sesame and odorless olive oil made by Barij Essential Oil Company are used. To blind the person analyzing the statistical data, the information of the two groups with the symbols A and B, without mentioning which type of oil was used in each group, will be provided to the statistical data analyzer. In order to blind patients, the necessary explanations will be given at the beginning of the research (In this research, two types of oils are used and you will be randomly placed in one of these two groups without knowing it). 2 Pressure ulcer. Intervention 1: Intervention group 1: Admission will be assessed with Braden instrument, and those with a score below 14 who are at moderate to severe risk of bed sore will be included in the study. Then, on a daily basis, pressure ulcer prevention methods, such as changing position at least every two hours, using small pillows between the legs or heels to remove and reduce pressure, controlling urinary incontinence, and using absorbent pads and cleansing the skin Infection) is routinely performed for patients. The researcher first tests some sesame oil on the inner area of the forearm and if there is no allergic reaction, in the next steps twice a day (9-21 hours), 2-3 cc on pressure points (hip, sacrum, heel) is rubbed and allowed 1-2 minutes to absorb for 7 days. Then the sacrum’ hip and heel of both groups of patients will be assessed on days 3 and 7 (based on previous studies as a cut point) in terms of incidence of pressure ulcer. Intervention 2: Intervention group 2: Admission will be assessed with Braden instrument, and those with a score below 14 who are at moderate to severe risk of bed sore will be included in the study. Then, on a daily basis, pressure ulcer prevention methods, such as changing position at least every two hours, using small pillows between the legs or heels to remove and reduce pressure, controlling urinary incontinence, and using absorbent pads and cleansing the skin Infection) is routinely performed for patients. The researcher first tests some olive oil on the inner area of the forearm and if there is no allergic reaction, in the next steps twice a day (9-21 hours), 2-3 cc on pressure points (hip, sacrum, heel) is rubbed and allowed 1-2 minutes to absorb for 7 days. Then the sacrum’ hip and heel of both groups of patients will be assessed on days 3 and 7 (based on previous studies as a cut point) in terms of incidence of pressure ulcer. 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 Parsa Ahmadi
No. 54, Dokhaniat town, Daneshgah town, Saqqez
Arak Iran (Islamic Republic of) 6681473677 +98 87 3631 3922 parsawe@gmail.com Arak University of Medical Sciences scientific fatemeh mehrabi
University Complex of the Great Prophet. sardasht . Arak
arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 86 3417 3505 fmehrabi1392@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in research Age over 18 years and under 65 years Patients who are at moderate to severe risk of bed sores and score less than 14 according to the nurse's diagnosis and based on the scaling of the removal tool Probability of continuing hospitalization in the ICU Less than 24 hours have passed since their admission to the ICU and they have not been admitted to another ward before Having a systolic blood pressure of 10 mm Hg and above Have a hemoglobin of 12 or higher. 18 years 65 years Both have Skin diseases (such as psoriasis, fungal infections, fleas and ticks) Having a pressure sore at the time of admission Systemic diseases such as diabetes, bleeding from the site of injury, heart failure, kidney failure and advanced stage cancer Receiving vasoactive drugs Having a fever (body temperature above 38.8) L89 Pressure ulcer Prevention Prevention Intervention group 1: Admission will be assessed with Braden instrument, and those with a score below 14 who are at moderate to severe risk of bed sore will be included in the study. Then, on a daily basis, pressure ulcer prevention methods, such as changing position at least every two hours, using small pillows between the legs or heels to remove and reduce pressure, controlling urinary incontinence, and using absorbent pads and cleansing the skin Infection) is routinely performed for patients. The researcher first tests some sesame oil on the inner area of the forearm and if there is no allergic reaction, in the next steps twice a day (9-21 hours), 2-3 cc on pressure points (hip, sacrum, heel) is rubbed and allowed 1-2 minutes to absorb for 7 days. Then the sacrum’ hip and heel of both groups of patients will be assessed on days 3 and 7 (based on previous studies as a cut point) in terms of incidence of pressure ulcer. Intervention group 2: Admission will be assessed with Braden instrument, and those with a score below 14 who are at moderate to severe risk of bed sore will be included in the study. Then, on a daily basis, pressure ulcer prevention methods, such as changing position at least every two hours, using small pillows between the legs or heels to remove and reduce pressure, controlling urinary incontinence, and using absorbent pads and cleansing the skin Infection) is routinely performed for patients. The researcher first tests some olive oil on the inner area of the forearm and if there is no allergic reaction, in the next steps twice a day (9-21 hours), 2-3 cc on pressure points (hip, sacrum, heel) is rubbed and allowed 1-2 minutes to absorb for 7 days. Then the sacrum’ hip and heel of both groups of patients will be assessed on days 3 and 7 (based on previous studies as a cut point) in terms of incidence of pressure ulcer. Prevention of pressure ulcers. Timepoint: at the start of reasrch and day 3 - 7. Method of measurement: Braden score. Vice Chancellor for Research and Technology of Arak University of Medical Sciences Approved 2022-03-06 Ethics committee of Arak University of Medical Sciences second partition, second floor , Vice Chancellor for Research and Technology، Arak University of Medical Sciences and Health Services, Payambar Azam (PBUH) University Complex, around Dr. Mehdi Charm Dooz Square, Dr. Mohammad Gharib Blvd, Sardasht region, Arak, Markazi Arak Markazi Iran (Islamic Republic of)