This study was carried out to determine the effects of aroma inhaling and essence massage on fatigue and quality of life in patients undergoing hemodialysis. This research is a parallel type clinical trial and was performed after obtaining permission and written presentation of the ethics committee of the University. The study population consisted of hemodialysis patients in dialysis centers in Tehran hospitals from whom 96 men and women were selected according to inclusion and exclusion criteria. They were willingness to participate in the research, having a healthy sense of smell, lack of allergic rhinitis or respiratory problems, lack of skin sensitivity to aromatic herbs, no drug abuse, no chronic physical disorders such as debilitating cardiovascular, respiratory, hepatic or mental diseases, death of the patient during the study, and kidney transplant. Sampling was performed based on odd and even days of the week at two work shifts of morning and evening. The samples were then randomly assigned in three groups of aroma inhalation, essence massage, and control. Aroma inhalation (lavender and orange) and essence massage was done 3 times weekly for 8 weeks. The patients were also taken the routine care of the ward. The control group only received the routine care. The data were collected using the Rhoten Fatigue Scale and the Kidney Disease Quality of Life instrument; they were completed by the researcher before the intervention and one and two months after it. The data were analyzed with SPSS and statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101819564N1
Registration date:2014-12-07, 1393/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-07, 1393/09/16
Registrant information
Name
Zahra Jalalian
Name of organization / entity
School of Nursing and Midwifery , Tehran of Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
shvaraei@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
A research project has presented in thesis form at the Tehran of Medical Science University
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aroma Inhalation and essence massage on fatigue and quality of life in hemodialysis patients
Public title
Effect aromatherapy on fatigue and quality of life in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
The main conditions for inclusion were age over 18 years;. at least 1 year of hemodialysis;. dialysis three times a week;. a willingness to participate in the research;. having a healthy sense of smell and no history of aromatherapy and massage therapy during the last 9 months;.
having a healthy sense of smell;. lack of allergic rhinitis or respiratory problems;. lack of skin sensitivity to aromatic herbs;. no drug abuse;. no chronic physical disorders such as debilitating cardiovascular, respiratory, hepatic or mental diseases;. The main conditions for exclusion were death of the patient during the study;. and kidney transplant.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran of Medical Science University
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
1638/130/د/93
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5 Chro
ICD-10 code description
Chronic uraemia End stage kidney disease
Primary outcomes
1
Description
Fatigue
Timepoint
Before and one month and two months after intervention.
Method of measurement
Rhoten Fatigue Scale
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and one month and two months after intervention
Method of measurement
KDQOL - SF™1/3 questionnaire
Intervention groups
1
Description
In group I, two drops of lavender essence with sweet orange at a ratio of 1:1 were dropped on a gas. The gas was pinned to the patient’s collar and the patient was asked to breathe normally for 15-20 minutes. This was done three times a week for 8 weeks.
Category
Other
2
Description
All subjects in the second group were undergone skin testing before massage with aromatic oil to ensure the absence of sensitivity; in case of redness, itching, swelling, and a positive test, the patient was excluded. The subjects in this group were massaged with 5 mL combination of lavender essence with sweet orange at a ratio of 1:1 which was diluted with sweet almond oil to 3%. The massage was performed on toes, feet and ankles as fondling, without hitting and pressure for 10 minutes during dialysis. This was done three times a week for 8 weeks. The patients were also received routine care of the ward
Category
Other
3
Description
The third group (control) received only the standard care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Unit of Imam Khomeini Hospital
Full name of responsible person
Jalalian zahra
Street address
Keshavarz Blvd.
City
Tehran
2
Recruitment center
Name of recruitment center
Dialysis Unit of Amir Alam Hospital
Full name of responsible person
Jalalian Zahra
Street address
North Saadi street
City
Tehran
3
Recruitment center
Name of recruitment center
Dialysis Unit of Haft Tir shohadye Hospital
Full name of responsible person
Jalalian Zahra
Street address
Rajai Shahid street, Rey Shahr
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research of Deputy, Tehran of Medical Sciences University
Full name of responsible person
Younesian Masood ,University of Research and Technology of Deputy
Street address
Sixth Floor, Central Building, Tehran of Medical Sciences University, Qods St, Keshavarz St, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research of Deputy, Tehran of Medical Sciences University
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
Tehran of Medical Sciences University
Full name of responsible person
Jalalian zahra
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran of Medical Sciences University, Eastern Nosrat St, Tohid Sq , Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
zjalali58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran of Medical Sciences University
Full name of responsible person
Varaei Shokouh
Position
PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Tehran of Medical Sciences University , Eastern Nosrat St, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
Shvaraei@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran of Medical Sciences University
Full name of responsible person
Jalalian zahra
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran of Medical Sciences University, Eastern Nosrat St, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
zjalali58@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)