Effect of a nasal drop of violet essential oil on the improvement of sleep quality in hemodialysis patients.

Determination of the effect of a nasal drop of violet essential oil on the improvement of sleep quality in hemodialysis patients.

The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized

This study was conducted to determine the effect of nasal drops on hemodialysis patients in hemodialysis department of Vasei Hospital in Sabzevar. Clinical observant and participants will be unaware of how they are grouped. Patients will be randomly assigned to the intervention group (violet essential oil) and control (paraffin oil). The response to treatment was evaluated using the Pittsburgh Sleep Quality Index (PSQI) at the end of the thirty days after the intervention for both groups.

Inclusion criteria: Patients aged 18 to 65 years, Have a score of 5 and more in sleep questionnaires, Being under dialysis for at least three months and continue dialysis at the same center. Exclusion Criteria: Infections of the upper respiratory tract, Cases of mental illness such as major depression, Schizophrenia, and mental retardation, Patients with infections, Malignancy or bad clinical conditions.

Intervention group: Patients in this group are trained to receive 2 drops of violet essential oil (Dr. Mohammad bagher minaee laboratory) one time in each nostril for thirty days, in addition to a possible routine treatment, half an hour before bedtime. Control group: Patients in this group are trained to receive 2 drops of paraffin oil (Kimiagartoos pharmaceutical company) one time in each nostril for thirty days, in addition to a possible routine treatment, half an hour before bedtime.

The quality of sleep

Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A and B are available to the researcher, Accordingly, 17 blocks are allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B are treated with Violet flower and Paraffin oil, respectively. First, we determine all foursome modes in which half of the individuals are assigned to group A and the other half to group B. Then we assign one of the digits 1 to 6 to each of the foursome combinations (which includes six modes). In the next step, we must randomly select 17 blocks of four and write their combinations in succession. For this we have to make 17 samplings with replacement from a six-member community; 17 times, choose a random number between 1 and 6 and this process will continue until the end of the sampling and the difference between the two groups will not exceed a maximum of two (half the size of the block).

Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The clinical observant and the participants are unaware of the groups. It should be noted that violet essential oil and Paraffin oil are similar in appearance, color, and packaging.