Objective: To determine the effect of aromatherapy with essential oils of lavender and peppermint on the sleep quality of cardiac patients
Design: randomized controlled clinical trials
Setting and conduct: sample size is 90 patients. Eligible patients will select by convenience sampling and randomly assign in intervention(groups 1 and 2) and control groups.
Inclusion and exclusion criteria: 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.
Interventions: Initially the quality of sleep questionnaire will be completed by patients. The study will perform for three consecutive nights, at bedtime. In groups one and two, of essential oil of lavender and mint will be used respectively and in group three sterile water will use. The essential oils will be spilled on the patient's cloth and will be attached to the patient's clothing for 20 minutes. On the morning of the fourth day, Pittsburgh Sleep Quality Index will be completed again by the patients.
The main outcome variables: quality of sleep
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601244736N10
Registration date:2016-11-04, 1395/08/14
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-11-04, 1395/08/14
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on cardiac patients' sleep quality
Public title
Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on cardiac patients' sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Consent to participate in the study, positive reaction to smell, The absence of any physical pain, the 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 nasal septum deviation, no addiction to drugs and alcohol.
Exclusion criteria: Unwillingness to continue to cooperate, Transition to other wards, and
Receiving narcotic and oxygen during aromatherapy
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The samples will be placed in one of the intervention and control groups by using a lottery
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
kermanshah
Postal code
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
kums.rec.1395.380
Health conditions studied
1
Description of health condition studied
cardiac disease
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
sleep quality
Timepoint
at the beginning of study and fourth day
Method of measurement
Pittsburgh sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In group I, for three nights before going to sleep at 22 o'clock, the two 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.
Category
Other
2
Description
In group 2, for three 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.
Category
Other
3
Description
In control group, for three 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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital of Kermanshah
Full name of responsible person
Alireza Khatony
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
alireza khatony
Position
PhD, Faculty Member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education, Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)