Protocol summary
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Study aim
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To determine the effect of aromatherapy with essential oils of lavender and peppermint on the sleep quality of cardiac patients
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Design
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Clinical trials, with parallel groups, randomized
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Settings and conduct
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In this study, heart patients hospitalized in Imam Ali Hospital and eligible individuals were randomly divided into three groups (two intervention groups and one control group). For 7 nights at 22 o'clock, in group one, three drops of peppermint essential oil, in group two, three drops of lavender essential oil, and in group three (control group), three drops of distilled water, on a napkin, and held for 20 minutes by the gauze , Will be attached in the chest area.
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Participants/Inclusion and exclusion criteria
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inclusion criteria include Consent to participate in the study, positive reaction to smell, earn points equal to or more than five from the Pittsburgh sleep quality Index. Exclusion criteria include Unwillingness to continue to cooperate, and administering oxygen for patients.
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Intervention groups
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In group1,for seven nights at 22 o'clock,the three drops of Peppermint essential oil will be used.Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for20minutes. In group2:for seven nights at 22 o'clock, the three drops of lavender essential oil will be used. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes In control group: for seven nights at 22 o'clock, the three drops of distilled water and is connected to the patient's clothing at the chest and inhaled for20 minutes
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Main outcome variables
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sleep quality
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201601244736N10
Registration date:
2016-11-04, 1395/08/14
Registration timing:
registered_while_recruiting
Last update:
2018-12-24, 1397/10/03
Update count:
1
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Registration date
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2016-11-04, 1395/08/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kermanshah University of Medical Sciences
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Expected recruitment start date
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2016-10-22, 1395/08/01
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Expected recruitment end date
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2017-10-23, 1396/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on cardiac patients' sleep quality
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Public title
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Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on cardiac patients' sleep quality
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Consent to participate in the stud
positive reaction to smell
he stability of vital signs (blood pressure, pulse, respiration and temperature)
having aged 18 to 65 years
earn points equal to or more than five from the Pittsburgh sleep quality Index
Lack of sinusitis and Pneumonia
no addiction to drugs and alcohol
Being alert
Passed 48 hours of admission
not having mental disease and no history of hospitalization in psychiatric wards
Do not take caffeine one hour before bedtime
Exclusion criteria:
Unwillingness to continue to cooperate
Transition to other wards or death
Receiving narcotic and oxygen during aromatherapy
critically ill patient during the study
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
105
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (peppermint and lavender) and control. Blocks were done as follows: To aromatic groups with peppermint essential oil and Lavender was assigned A and B codes respectively, and the control group received C code. The study blocks were ABC, ACB, BAC, BCA, CAB, CBA, BCC, CAB, CAB, and the ABC block was selected as the first block. Patients were assigned to peppermint, lavender, and control groups, respectively, and this method continued until the samples were completed.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-09-28, 1395/07/07
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Ethics committee reference number
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kums.rec.1395.380
Health conditions studied
1
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Description of health condition studied
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Coronary Artery Disease
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ICD-10 code
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I25.1
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ICD-10 code description
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Coronary Artery Disease
2
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Description of health condition studied
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Myocardial infarction
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ICD-10 code
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I22
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ICD-10 code description
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Myocardial infarction
3
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Description of health condition studied
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Congestive heart failure
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ICD-10 code
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I50.0
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ICD-10 code description
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Congestive heart failure
Primary outcomes
1
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Description
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sleep quality
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Timepoint
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at the beginning of study and Eighth day
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Method of measurement
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Pittsburgh sleep quality questionnaire
Intervention groups
1
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Description
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In group I, for seven nights before going to sleep at 22 o'clock, the three drops of lavender essential oil will be used. Trade name of this essence is lavender essential oil and its scientific name is Lavandula stoechas which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included are linalyl acetate and linalool. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
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Category
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Other
2
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Description
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In group 2, for seven nights before going to sleep at 22 o'clock, the three drops of Peppermint essential oil will be used. Colpermin' is a pharmaceutical brand name for peppermint oil and Its scientific name is Mentha piperita which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included Menthol, Mentol and methyl acetate. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
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Category
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Other
3
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Description
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In control group, for seven nights before going to sleep at 22 o'clock, the three drops of distilled water will be used which is produced by Tehran Samen Company. Distilled water will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The main consequence is the possibility of sharing information.
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When the data will become available and for how long
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Six months after the publication of the article
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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There is no right to extract the article from the documentation.
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From where data/document is obtainable
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Dr. Alireza Khatony
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What processes are involved for a request to access data/document
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Within a week of receiving the email, it will be answered.
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Comments
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