Investigating the effect of aromatherapy with passiflora oil on sleep quality and life balance of patients undergoing hemodialysis

Determining the effect of aromatherapy with passiflora oil on sleep quality and life balance of patients undergoing hemodialysis in the hemodialysis department of Shahid Modares kashmar, Valiasr Bardskan and Khatam al Anbia Khalilabad in 2023

A clinical trial with a control group, with parallel groups, three blinded, randomized, on 72 patients, randomization will be done using the block randomization method, with the help of Random Allocation software.

Patients suffering from chronic kidney failure, undergoing hemodialysis in the dialysis centers of Shahid Modares, Kashmir, Vali Asr Bardskan, and Khatam Al Anbia, Khalilabad, who suffer from sleep disorders, are assigned to two intervention and control groups by block randomization method. . In this study, the researcher, patients, and data safety and monitoring committee will be blinded

Conscious patients with aged 17 to 80 years, with a history of at least 6 months of hemodialysis twice a week and three hours each time, with a sleep score of 5 and above 5 of the Pittsburg questionnaire, who don't have smell disorders, severe mental disorders, and the use of drugs or sedatives, breathing problems known as asthma, history of allergy to medicinal plants, skin sensitivity following the test of amaranth oil on the front part of the patient's forearm

For six weeks, the intervention group put two pieces of cotton soaked in 7 drops of passiflora oil each night on both sides of their pillow before sleeping, inside a cellophane container designed by the researcher. They have to put it away and throw out next morning. The same procedure will be performed in the control group and a placebo (sweet almond oil) will be used instead of passiflora oil

Sleep quality, life balance

In each treatment center, patients will be allocated to intervention and control groups by permuted block randomization. For this, we are about to have 12 blocks of 6 members. According to the number of patients in each of the centers (70 patients in Kashmar, 28 patients in Bardaskan and 21 patients in Khalilabad), 3 blocks will be allocated in Bardaskan center, 3 blocks in Khalilabad center, and 6 blocks in Kashmar center. Random Allocation software will be used for determination of random blocks. In order to hide the random allocation, we will use opaque sealed envelopes with a random sequence. In this method, which is abbreviated as the SNOSE method, after creating a random sequence with the help of software, a number of envelopes will be prepared based on the sample size, each of the created random sequences will be recorded on cards and placed inside the envelopes. Then the envelopes are numbered in the same order as the created sequence. Then, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the group assigned to the patient will be determined.

For blinding purposes, random allocation will be done by one of the investigators, then the study will be performed by another investigator. In this way, the researcher who provides the oils to the patients is not aware of the type of oil and patients will not be informed about the type of oil either. Patients will receive identical packages. Finally, the data will be prepared for analysis. At the time of analysis, the researcher will not be aware of the patient grouping. In this case, the study is three-way blind.

Part of the research sample data after deid entification will be shared

After collecting and analyzing the data, the results will be published in the form of an article became

The results will be published for all researchers working in the class

The results of this study can be used by all people who are in the field of treatment Caring for patients with chronic kidney failure and undergoing hemodialysis are being used.

Applicants can contact Ms. Marzieh Dolatshahi at the address of Sabzevar University of Medical Sciences, Faculty of Nursing and Midwifery, refer to the student research committee unit

Applicants can obtain documents after submitting an application to the student research committee and obtaining the necessary permits.