Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on sleep quality of cancer patients admitted to Taleghani Hospital in Kermanshah, 2018
To determine the effect of aromatherapy with essential oils of lavender and peppermint on the sleep quality of cancer patients
Design
randomized controlled clinical trials
Settings and conduct
The study place is the oncology ward. Eligible patients will be select by convenience sampling and randomly assign in intervention(groups 1 and 2) and control groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include the consent of the patient's physician and the informed consent of the patient to participate in the study; Having full consciousness ; positive reaction to smell; ability to answer questions; lack of physical pain; Stability of vital signs (blood pressure, pulse, respiration and temperature); Not having a history of psychiatric illness; aged 18-65 years; lack of sinusitis and nasal deformities and skin sensitivities; lack of addiction to cigarettes, drugs and alcohol; lack of clinical acute conditions such as nausea and vomiting; no history of respiratory problems such as asthma; Do not drink caffeine drink from an hour before the intervention; Earn points equal to or more than five from the Pittsburgh Sleep Quality Questionnaire.
Exit criteria include Unwillingness to continue cooperation by the patient or his physician, transferring to another ward, receiving a narcotic drug during a aromatherapy, Oxygen administration for the patient , and occurrence of Crisis or unforeseen incident.
Intervention groups
Initially the quality of sleep questionnaire will be completed by patients. The study will perform for seven consecutive nights, at bedtime. In groups one and two, of essential oil of Peppermint and lavender will be used respectively and in group three sterile water will be use. The essential oils will be spilled onto the napkin and attached to the patient's clothes for 20 minutes. On the morning of the eighth day, Pittsburgh Sleep Quality Questionnaire will be completed again by the patients.
Main outcome variables
Quality of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100913004736N21
Registration date:2018-03-11, 1396/12/20
Registration timing:prospective
Last update:2018-03-11, 1396/12/20
Update count:0
Registration date
2018-03-11, 1396/12/20
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
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-07-23, 1397/05/01
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 sleep quality of cancer patients admitted to Taleghani Hospital in Kermanshah, 2018
Public title
The effect of aromatherapy with the essential oils of lavender and peppermint on sleep quality of cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The satisfaction of the patient's physician and the informed consent of the patient to participate in the study
Having full consciousness
positive reaction to smell
Ability to answer questions
The absence of any physical pain
the stability of vital signs (blood pressure, pulse, respiration and temperature)
having aged 18 to 65 years
Lack of sinusitis and nasal septum deviation and skin sensitivities
No addiction to drugs and alcohol and smoking
The absence of acute clinical conditions such as nausea and vomiting
Not having a history of respiratory problems such as asthma
Do not drink caffeine drink from an hour before the intervention
Earn points equal to or more than five from the Pittsburgh Sleep Quality Questionnaire
Lack of primary tumor or metastasis in the central nervous system
Exclusion criteria:
Unwillingness to continue cooperation by the patient or his/her physician
Transition to other wards
Receiving narcotic during aromatherapy
Oxygen administration for the patient
Occurrence of Crisis or unforeseen incident
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:
105
Randomization (investigator's opinion)
Randomized
Randomization description
To do this, formulate the Excel software environment and generate random numbers of 5 digits. Anyone who enters the study is assigned a number, the last number on the right will be decisive. Patients with the last digits to the right of these numbers are 1, 2.3, will be in Lavender group.Patients whose last digit is 4, 5, 6, and Patients with a final digit of 7, 8, 9 will be assigned in the peppermint and control group respectively.
,
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی کرمانشاه
Street address
Shahid Beheshty Blvd., Kermanshah University of Medical Sciences, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
kums.rec.1395.647
Health conditions studied
1
Description of health condition studied
Cancer disease
ICD-10 code
Z85.8
ICD-10 code description
Personal history of malignant neoplasms of other organs and systems
Primary outcomes
1
Description
sleep quality; In this study, patients with a score of 5 or more from the Pittsburgh Questionnaire are enrolled in the study.
Timepoint
At the beginning of study and Eighth day
Method of measurement
Pittsburgh Sleep Quality Questionnaire will be used.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group one , 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 Barich Essence Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included Menthol, Menton and methyl acetate. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the collar and inhaled for 20 minutes.
Category
Treatment - Other
2
Description
Intervention group: In group Two , 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 Barich Essence 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 Collar and inhaled for 20 minutes.
Category
Treatment - Other
3
Description
Control group: In this 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 Collar and inhaled for 20 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital of Kermanshah
Full name of responsible person
Alireza Khatony
Street address
Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2102
Email
akhatony@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Fax
+98 83 3838 4185
Email
farid_n32@yahoo.com
Web page address
http://www.vc-research.kums.ac.ir/
Grant name
Thirty two million three hundred and Eighty thousand rials
Grant code / Reference number
2
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
67
Phone
+98 38279394
Email
akhatony@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ashayer Sreet, Kermanshah School of Nursing and Midwifery, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 382789394
Email
akhatony@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
+98 83 3827 9394
Email
akhatony@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main outcome of the study is available for sharing.
When the data will become available and for how long
Six months after the publication of the results in the form of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Only to conduct similar studies in other populations.
From where data/document is obtainable
Alireza Khatuni with below email address:
akhatony@gmail.com
and phone number 08338282102
What processes are involved for a request to access data/document
A week after receiving an email or phone call, it will take action.