The efficacy of Satoria hortensis essential oil on pain caused by arteriovenous fistula puncture of patients undergoing hemodialysis: A randomized double-blinded placebo-controlled clinical trial

Reduction of pain caused by arteriovenous fistula needling in dialysis patients using a natural and herbal method. By examining the effect of this essential oil on reducing pain and improving the condition of patients, this research aims to improve the existing treatment methods and introduce new natural treatments with minimal complication methods to manage acute pain.

Randomized double-blind crossover controlled clinical trial on 30 patients and Excel software will be used for randomization.

Patients were referred to the dialysis centers of Namazi and Shahid Faqihi hospitals of Shiraz University of Medical Sciences.

Inclusion criteria: Male and female patients with chronic kidney problems between 18 and 70 years old, dialysis at least 2 times a week, a history of dialysis through arteriovenous vessels for at least 3 months, and full consciousness and signing a written informed consent form. Exclusion criteria: Allergy to herbal products, skin disease and injury to the study site, use of oral analgesics in the past 6 hours or topical Arteriovenoussite pain medication in the past 24 hours, diabetic neuropathy or other types of neuropathy, failure of the initial attempt to achieve Arteriovenous vessels.

For each patient, one tip of finger unit (TUF) of the gel (gel containing essential oil and placebo) will be applied within a radius of 2 cm from the entry point of the arteriovenous fistula (AVF). After ten minutes, an experienced nurse will puncture the AVF.

Demographic characteristics such as age, gender, educational status, and number of dialyses per week are recorded. The main outcome measure is the amount of pain during AVF needling, measured using the video analog scale (AVS). This scale is known as a valid and reliable tool.

To assign people to groups A and B, we will use the block of four method. The randomization list will be generated by a biostatistician using Excel software, and a third party will determine which groups are in treatment and which are placebo by throwing a coin.

Using similar non-transparent containers with consecutive numbering will guarantee the lack of information about the allocation to groups, which will be considered. Both types of gel (gel containing essential oil and placebo gel) will be the same in terms of physical characteristics (including consistency, color, and smell of the product). In addition, they will be packed in containers of the same shape and size. It should be noted that each container has a code that only the person who produced it knows about its contents, so patients, nurses, doctors, and researchers are unaware of the drugs used.