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IRCT20190531043778N2 IRCT 2021-04-13 Khalkhal University of Medical Sciences Comparison of The Effects of Aromatherapy with Lavender Essence Oil and Lavender Tea on Pain, Sleep Quality and Fatigue Comparison of The Effects of Aromatherapy with Lavender Essence Oil and Lavender Tea on Pain, Fatigue and Sleep Quality in Hemodialysis Patients: A Controlled Clinical Trial 2021-05-05 anticipated 90 Complete https://irct.ir/trial/54872 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The placement of individuals will be random, simple and blocked in one of the three groups, intervention A (aromatherapy), intervention B (lavender tea) or control group C. First, various triple blocks will be written on different cards (ABC, CAB, CBA, BCA, BAC and ACB). One of these blocks will be randomly selected and patients will be allocated based on selected card. Then randomization will be performed for other patients, Blinding description: Questionnaires will be completed by a person who is not aware of patients' allocation to groups. 3 Hemodialysis. Intervention 1: Intervention group: First: Inhalation of lavender with a concentration of 10% for six times in two weeks, each time 5 drops of lavender extract prepared from Barich Essential Oil Company of Iran. Intervention 2: Intervention group 2: participants will be asked to put lavender tea prepared in the form of a tea bag with 2 grams of dried lavender flowers in 300 ml of boiled water for 10 to 15 minutes for two weeks at night, 1 hour before bedtime. Intervention 3: Control group: During the first session, after explaining the objectives of the study and obtaining informed consent, the questionnaire will be completed by the research colleague and no extract will be provided to them. After 14 days, the questionnaire will be completed for them again. Yes - There is a plan to make this available What will be shared: All data from the study will be published after the individuals are not identified When: Access time from 2023 To whom: Academic researchers Conditions: Dissemination of data is possible only to verify its accuracy and no statistical analysis and activity is acceptable. Where to obtain: Khalkhal University of Medical Sciences How to obtain: Send a letter to Khalkhal Medical Sciences Research Vice-Chancellor Comments:
public Khadijeh Nasiri
Muzaffar St
Khalkhal Iran (Islamic Republic of) 5681761351 +98 45 3243 2002 khadije.nasiri@yahoo.com Khalkhal University of Medical Sciences scientific Khadijeh Nasiri
Muzaffar St
Khalkhal Iran (Islamic Republic of) 5681761351 +98 45 3243 2002 khadije.nasiri@yahoo.com Khalkhal University of Medical Sciences Iran (Islamic Republic of) Perform permanent hemodialysis Have a history of hemodialysis for at least six months Age group 18 to 65 years Ability to communicate Lack of allergy to the smell of plant extracts Absence of respiratory diseases such as asthma, having a healthy sense of smell (through patient statements and nasal examination for non-obstruction) Kidney transplant candidate Non-pregnancy (for women) No addiction Not receiving painkillers, hypnotics and sedatives in the last 3 hours 18 years 65 years Both Lack of interest in participating in the study Z99.2 Dependence on renal dialysis Rehabilitation Rehabilitation N/A Intervention group: First: Inhalation of lavender with a concentration of 10% for six times in two weeks, each time 5 drops of lavender extract prepared from Barich Essential Oil Company of Iran Intervention group 2: participants will be asked to put lavender tea prepared in the form of a tea bag with 2 grams of dried lavender flowers in 300 ml of boiled water for 10 to 15 minutes for two weeks at night, 1 hour before bedtime Control group: During the first session, after explaining the objectives of the study and obtaining informed consent, the questionnaire will be completed by the research colleague and no extract will be provided to them. After 14 days, the questionnaire will be completed for them again. Score of Pain. Timepoint: At the beginning of the study (before the intervention) and 14 days after the start of intervention. Method of measurement: Visual Analogue Scale questionnaire. Score of Fatigue. Timepoint: At the beginning of the study (before the intervention) and 14 days after the start of intervention. Method of measurement: Scale Severity Fatigue questionnaire. Score of Sleep Quality. Timepoint: At the beginning of the study (before the intervention) and 14 days after the start of intervention. Method of measurement: Pittsburgh sleep quality index questionnaire. Khalkhal University of Medical Sciences Approved 2021-03-01 Ethics Committee of Khalkhal University of Medical Sciences Muzaffar St Khalkhal Ardabil Iran (Islamic Republic of)