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IRCT20181006041252N8 IRCT 2019-01-25 Sabzevar University of Medical Sciences Effect of a nasal drop of violet essential oil on the improvement of sleep quality in hemodialysis patients. Effect of a nasal drop of violet essential oil on the improvement of sleep quality in hemodialysis patients. 2018-12-29 anticipated 68 Complete https://irct.ir/trial/36402 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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), Blinding description: 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. 3 The quality of sleep. Intervention 1: 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. Intervention 2: 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. 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 No more information
public Dr. Fereshte Ghorat
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8319 drghorat@gmail.com Sabzevar University of Medical Sciences scientific Dr. Fereshte Ghorat
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8319 drghorat@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 65 years Have a score of 5 and more in sleep questionnaires Being under dialysis for at least three months Continue dialysis at the same center 18 years 65 years Both Infections of the upper respiratory tract Cases of mental illness such as major depression, schizophrenia, mental retardation Patients with infections, malignancy, or bad clinical conditions F15.282 Other stimulant dependence with stimulant-induced sleep disorder Treatment - Drugs Treatment - Drugs 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. Timepoint: At the beginning of the study (before the intervention), 2 and 4 weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Itching. Timepoint: At the beginning of the study (before the intervention), 2 and 4 weeks after the intervention. Method of measurement: 5-D itch questionnaire. Patient Satisfaction. Timepoint: At the beginning of the study (before the intervention), 2 and 4 weeks after the intervention. Method of measurement: Treatment acceptability questionnaire (TAD). Sabzevar University of Medical Sciences Approved 2019-01-13 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)