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IRCT20221212056801N1 IRCT 2023-01-09 Sabzevar University of Medical Sciences Investigating the effect of aromatherapy with passiflora oil on sleep quality and life balance of patients undergoing hemodialysis Investigating the effect of aromatherapy with passiflora oil on sleep quality and life balance of patients undergoing hemodialysis 2023-01-27 anticipated 72 Complete https://irct.ir/trial/67698 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Chronic renal failure. Intervention 1: Intervention group: For six weeks, the intervention group is requested to put two pieces of cotton soaked in 7 drops of 30% concentrated 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. Intervention 2: Control group: For six weeks, the Control group is requested to put two pieces of cotton soaked in 7 drops of sweet almond 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. Yes - There is a plan to make this available What will be shared: Part of the research sample data after deid entification will be shared When: After collecting and analyzing the data, the results will be published in the form of an article became To whom: The results will be published for all researchers working in the class Conditions: 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. Where to obtain: 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 How to obtain: Applicants can obtain documents after submitting an application to the student research committee and obtaining the necessary permits. Comments:
public Marzieh Dolatshahi
No. 49,th6 Shahid Sadeghi Street
Kashmar Iran (Islamic Republic of) 9671773453 +98 51 5772 3106 dolatshahi1784@gmail.com Sabzevar University of Medical Sciences scientific Mojgan Ansari
Boulevard nuclear shohaday. Sabzevar University of Medical Sciences campus
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 mojganansari01@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) complete awareness Age between 19-70 years A history of at least 6 months of hemodialysis dialysis twice a week for three hours each time Having a Sleep Quality score of 5 and above 5 of the above 5 based on the Pittsburgh questionnaire 18 years 70 years Both Presence of smell disorder Severe mental disorder and the use of drugs or sedatives respiratory disorder such as asthma History of allergy to herbal medicine skin sensitivity following the test of passiflora oil on the front part of the patient's forearm N18.4 Chronic kidney disease, stage 4 (severe) Treatment - Other Treatment - Other Intervention group: For six weeks, the intervention group is requested to put two pieces of cotton soaked in 7 drops of 30% concentrated 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 Control group: For six weeks, the Control group is requested to put two pieces of cotton soaked in 7 drops of sweet almond 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 Sleep quality score in the Pittsburgh Questionnaire. Timepoint: Before the start of the study and 6 weeks after the start of aromatherapy with passiflora oil. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Life balance score in Matuska questionnaire. Timepoint: Before the start of the study and 6 weeks after the start of aromatherapy with passiflora oi. Method of measurement: Matuska's Life Balance Questionnaire. Sleep quality score in the Pittsburgh Questionnaire. Timepoint: Before the start of the study and 6 weeks after the start of aromatherapy with passiflora oil. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Life balance score in Matuska questionnaire. Timepoint: Before the start of the study and 6 weeks after the start of aromatherapy with passiflora oil. Method of measurement: Matuska's Life Balance Questionnaire. Sabzevar University of Medical Sciences Approved 2023-01-01 research Ethics committee of Sabzevar University of Medical Sciences Blvd. Shohada Nuclear, Sabzevar University of Medical Sciences campus Sabzevar Razavi Khorasan Iran (Islamic Republic of)