Comparison the effects of inhalation aromatherapy with essential oil of Lavender and Orange on fatigue, anxiety and depression in hemodialysis patients
Objective: Comparing the effects of inhalation aromatherapy with Lavender and Orange essential oils on the level of fatigue, anxiety and depression in hemodialysis patients.
Design: randomized controlled clinical trial.
Setting and conduct: sample size is 90 patients. Eligible patients randomly will be assign to intervention and control groups.
Inclusion and exclusion criteria: inclusion criteria include Consent to participate in the study, age 18-65 years, Lack of allergies, having healthy sense of smell. Exclusion criteria is the patient's unwillingness to continue cooperation, become critically ill during the study, and receiving narcotic and oxygen during aromatherapy.
Interventions: The study will perform for two consecutive weeks. Initially the DASS-21 and FSS questionnaire will be completed by patients. In groups one and two, inhalation of five drops of Lavender and Orange essential oils will be used for 30 minutes, respectively. Control group will be received inhalation of five drops of sterile water for 30 minutes. These essences will be spilled on a piece of cotton and will be attached to the patient`s cloth on the chest for 30 minutes. At the end of two weeks the questionnaires will be complete again by the patients.
The main outcome variables: fatigue, anxiety and depression
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610244736N17
Registration date:2016-12-10, 1395/09/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-10, 1395/09/20
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
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of inhalation aromatherapy with essential oil of Lavender and Orange on fatigue, anxiety and depression in hemodialysis patients
Public title
Effect of aromatherapy on fatigue, anxiety and depression in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness for participating in the research; doing hemodialysis three times a week; doing hemodialysis for at least 6 month; age between 18-65 year; being conscious; having verbal contact; having no allergy to essential oils of Lavender and Orange; having healthy sense of smell.
Exclusion criteria: the patient's unwillingness to continue cooperation; become critically ill during the study; 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Boulevard, Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
KUMS.RES.1395.510
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Fatigue
Timepoint
at the beginnig of the study and fourteenth day
Method of measurement
fatigue severity scale
2
Description
depression
Timepoint
at the beginnig of the study and fourteenth day
Method of measurement
DASS-21 questionaire
3
Description
anxiety
Timepoint
at the beginnig of the study and fourteenth day
Method of measurement
DASS-21 questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Before intervention the fatigue, depression and anxiety questionnaires will be completed by the samples. Intervention will be conducted for two consecutive. For this purpose, in group one 5 drops of Lavender essential oil will be dropped on a piece of cotton and then it will be attached to the patient`s clothing on chest area and will be inhaled for 30 minutes by the patient. One hundred percent concentration of essential oils are used. The time of using the fragrances is half an hour after initiation of dialysis. At the end of two weeks, the questionnaires will be completed again by the patients.
Category
Other
2
Description
Intervention2: In group 2 before intervention the fatigue, depression and anxiety questionnaires will be completed by the samples. Intervention will be conducted for two consecutive weeks. In group one 5 drops of Orange essential oil will be dropped on a piece of cotton and then it will be attached to the patient`s clothing on chest area and will be inhaled for 30 minutes. One hundred percent concentration of essential oils are used. The time of using the fragrances is half an hour after initiation of dialysis. At the end of two weeks, the questionnaires will be completed again by the patients.
Category
Other
3
Description
In the control group for two consecutive weeks, 5 drops of distilled, will be dropped on a piece of cotton by dropper and it will be attached to the patient's clothing and will be inhaled by the patient for 30 minutes. Before and after the intervention the fatigue, depression and anxiety questionnaires will be completed by the samples.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Alireza Khatony
Street address
Kermanshah University of Medical Science, Shahid Beheshti Boulevard, Kermanshah, Iran
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Cancellor for Research, Kermanshah University of Medical Science
Full name of responsible person
Behrooz Hamzeh
Street address
kermanshah, Shahid Beheshty Boulevard, kermanshah university of medical science
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Cancellor for Research, Kermanshah University of Medical Science
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 Boulevard, 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-faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Boulevard, 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 Miwifery, Dolat Abaad, 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)