Comparison of the effectiveness of rose oil and fish oil versus placebo in preventing pressure ulcers in patients admitted to intensive care units: a double-blind randomized clinical trial

To assess the effect of the effectiveness of rose oil and fish oil versus placebo in preventing pressure ulcers in patients admitted to intensive care units

This is a Phase III double-blind randomized clinical trial with a control group with parallel groups, in which 66 eligible patients will be randomly assigned to the intervention and control groups using block randomization.

This study will be conducted at the Besat Hospital in Hamadan, involving 66 eligible patients admitted to intensive care units. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.

Inclusion criteria: Age 18 to 75 years, Admission to the intensive care unit within the last 24 hours, Completely intact skin or, at most, blanchable erythema in the sacral region, Exclusion criteria: Stage 1 or higher pressure ulcer in the sacral region, Any severe active skin disease, Extensive burns or open wounds in the sacral or gluteal regions, Malnutrition, Diarrhea

Intervention Group 1: Application of rose oil to the patient's sacral region three times daily for five days Intervention Group 2: Application of fish oil containing omega-3 fatty acids to the patient's sacral region three times daily for five days Control Group: Application of polyethylene glycol 400 to the patient's sacral region three times daily for five days

Primary outcome: Average time to pressure ulcer onset

In this study, random assignment of patients to the intervention and control groups will be performed using block randomization. To achieve this, six sheets of paper will be prepared - two with the name of "Intervention 1," two with the name of "Intervention 2," and two with the name of "Control." These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.

The drugs will be administered in coded envelopes. Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. The person delivering the medications will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a double-blind study.