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IRCT20180924041109N2 IRCT 2019-05-05 Mazandaran University of Medical Sciences Effect aromatherapy with lavender essential oil on sleep quality and fatigue The effect of aromatherapy with lavender essential oil on sleep quality and fatigue of major depressed patients. 2018-10-07 anticipated 95 Complete https://irct.ir/trial/34892 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are blocked by random blocking method based on age variables. 80 qualifier depressed patients with 10% probability of loss of case will be selected and 40 person will be allocation randomly blocking to either one intervention and control group. For random selection, this will be done in the first in form blocks of 4 person, include each block 4 person in 6 states (four can take six different modes, AABB1, BBAA2, ABAB3, BABA4, ABBA5 BAAB6) And 20 blocks of 4 person. In each group, the number of people will be equal to the intervention and control. Based on the random number table, according to the sample size, 20 blocks of 4 person are selected based on each of the 6 modes and will be arranged in serial. The method of allocation samples to each of the blocks is define by this pattern. Blocking with code A and B is define, A indicative the allocation to the aromatherapy group and B is allocation to the placebo group, then the patients will be placed in blocks according to the Respectively, entering the study, Blinding description: The present study is a blind one. Participants are unaware of how they are in the intervention and control group, but the researcher and the rest of the people in the research team are aware. N/A major depression. Intervention 1: Intervention Group: aromatherapy with Lavender essential oil. Intervention 2: Control group: Aromatherapy with sweet almond oil. 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 Yadollah Jannati
Vesal Street, Amir Mazandarani Blvd
Sari Iran (Islamic Republic of) 4816715793 +98 11 3310 9808 jannati.yadollah@gmail.com Mazandaran University of Medical Sciences scientific Yadollah Jannati
Vesal Street, Amir Mazandarani Blvd
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7342 jannati.yadollah@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Aged 18-60 Having Complete consciousness Have reading and writing skills Having a healthy sense of smell (examining the nerve pair 1) If you take antidepressants, you are less than 3 weeks old after taking antidepressants Earn score 5 and above Pittsburgh Sleep Quality Questionnaire A score of 7-24 Hamilton questionnaires Obtain 21 and higher Multidimensional Fatigue Inventory Questionnaire (MFI) 18 years 60 years Both Drinking alcohol and cigarettes and drugs Taking hypnotic drugs and antihistamines Allergic rhenitis, asthma and respiratory diseases The use of known methods of complementary and traditional medicine that affects the quality of sleep coincident with this intervention. Gain score higher than 2 based on the title of suicide from the Hamilton Measurement Scale for depression History of allergy to aromatic substances and lavender oil Intolerance to lavender smell Failure to intervene for more than three continues days Crisis or accidental events Hospitalized during intervention A fetus and appearance physical or psychological disorder that diagnosed by a psychiatrist based on DSM5 that causes sleep disturbance during the intervention. Pregnancy History of migraine and chronic headaches Having a night shift job indisposition to continue the intervention and non-cooperation during the study F32.1 Major depressive disorder, single episode, moderate Treatment - Drugs Placebo Intervention Group: aromatherapy with Lavender essential oil Control group: Aromatherapy with sweet almond oil Sleep quality and fatigue. Timepoint: before intervention and 15 days after starting to use lavender essential oil. Method of measurement: Pittsburgh sleep quality questionnaire and Multidimensional Fatigue Inventory questionnaire MFI. Mazandaran University of Medical Sciences Approved 2018-09-26 Ethics committee of Mazandaran University of Medical Sciences Teachers 'Street, Deputy of Research and Technology of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)