Determination the effect of lavender essential oil on the quality sleep and fatigue in patients with major depression
Special goals: Determining the quality sleep and fatigue in the intervention group before and after intervention. Determination sleep quality and fatigue in the control group before and after the intervention
Design
A single blind randomized clinical trial with a pretest-post test design with a placebo controlled group. The statistical population included all patients referring to the specialized clinic of Yahyanezhad Hospital Babol, who have a mild to moderate depression. The sample size is calculated on the basis of the study of Lee et al. 34 person. Because of the 10% Probability of sample Falling out, 40 people will be calculated per group. Sampling method in this research was available. Patients are blocked by random blocking method based on age variables.
Settings and conduct
Eligible patients were selected from patients referring to the psychiatric clinic of Yahyanezhad Hospital. This is a single-blind study and only patients do not know Which group to enter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 18-60 years,Literacy reading and writing, having a healthy sense of smell, Exclusion criteria: alcohol and cigarettes and opiate material, taking hypnotic drugs, asthma and respiratory diseases, history of allergy to aromatic substances, pregnancy, history of migraine and chronic headaches, having a night shift job
Intervention groups
The intervention group will use the aromatherapy for 14 Continuous nights with 2 drops of lavender essential oil at a Density 10%. Patients in the control group will use the placebo.
Main outcome variables
sleep quality, Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180924041109N2
Registration date:2019-05-05, 1398/02/15
Registration timing:retrospective
Last update:2019-05-05, 1398/02/15
Update count:0
Registration date
2019-05-05, 1398/02/15
Registrant information
Name
Yadollah Jannati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 9808
Email address
jannati.yadollah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with lavender essential oil on sleep quality and fatigue of major depressed patients.
Public title
Effect aromatherapy with lavender essential oil on sleep quality and fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
95
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Teachers 'Street, Deputy of Research and Technology of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2018-09-26, 1397/07/04
Ethics committee reference number
IR.MAZUMS.REC.1397.164
Health conditions studied
1
Description of health condition studied
major depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: aromatherapy with Lavender essential oil