A clinical trial (cross-over) study was performed. After obtaining the written ethical permission from the Ethics Committee of Zabol University of Medical Sciences, the study was performed on patients undergoing Hemodialysis in Hemodialysis ward, Zabol Imam Khomeini hospital. Based on the inclusion criteria, the samples were randomized in two groups (A and B). The group A inhaled lavender extract first, then they received orange extract. The group B inhaled orange extract first, then they received orange extract. Each session was two weeks. There was also a two washout period between sessions. In the first stage of intervention all patients trained how to use the orange and lavender extracts. The night after hemodialysis, a drop of lavender or orange extract was poured onto a 2 x 2 cm gauze and trained to attach it on their shirt by a paper clip. The procedure was repeated three times a week. The level of fatigue and sleep quality was measured at the end of each week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060222772N1
Registration date:2016-06-17, 1395/03/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-17, 1395/03/28
Registrant information
Name
Abbas Balouchi
Name of organization / entity
Zabol University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 1271
Email address
a.baluchi@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Zabol University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aroma Inhalation of Orange and Levander Essence on fatigue and quality of Sleep in hemodialysis patients
Public title
Effect aromatherapy on fatigue and quality of Sleep in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Hemodialysis three times a week; having a history of Hemodialysis treatments more than six months; informed consent for the study; lack of acute stressful event in the past 6 months (Death of loved ones); lack of history of allergy to aromas; lack of proven problem in sense of smell (healthy olfactory sense that was evaluated by a physician).
Exclusion criteria: unwillingness to participate in the trial; kidney transplantation; hospitalization in another ward except Hemodialysis ward for other reason (MI, CVC and dyspnea).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zabol University of Medical Science
Street address
Shahid Rajae st-Research and technology Deputy of Zabol University of Medical science
City
Zabol
Postal code
9861663335
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
Zbmu.1.Rec.1394.132
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 end of first and second weeks in first stage of intervention stage and end of third and fourth Weeks in two stage of intervention
Method of measurement
multidimensional fatigue inventory (MFI-20)
Secondary outcomes
1
Description
Quality of Sleep
Timepoint
Before and end of first and second weeks in first stage of intervention stage and end of third and fourth Weeks in two stage of intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Intervention groups
1
Description
In the first stage of intervention for study of Lavender effect on fatigue and sleep quality , patients were trained in order to The night after hemodialysis, one drop lavender or orange extract was poured onto a 2 x 2 cm gauze and attached to the patient`s shirt by special pins. Then the patients began to rest. This was repeated three times a week. It was, however, done every day during the second week. Patients also received their normal care. The level of fatigue and sleep quality was studied at the end of each week by related questionnaire.
Category
Other
2
Description
In the second stage,for study effect of Orange on fatigue and quality of sleep , groups were exchanged to study the intervention of orange extracts. Group 1 received lavender extract, while group 2 received orange extract. Fatigue and sleep quality were studied at the end of each week.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Center of Imam Khomeini Hospital
Full name of responsible person
Abbas Balouchi
Street address
Shahid Motahri ST-Special Disease Center
City
Zabol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Science
Full name of responsible person
Zahra Speheri
Street address
Shahid rajaie ST- Research Deputy of Zabol University of Medical Science
City
zabol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Abdolghani Abdollahimohammad
Position
PhD of Nursing
Other areas of specialty/work
Street address
Ferdowsi ST,Nursing and Midwifery School
City
Zabol
Postal code
9861663335
Phone
+98 54 3223 0770
Fax
Email
a.baluchi@zbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Nosratollah Masinaeinegad
Position
MSc of Nursing
Other areas of specialty/work
Street address
Ferdowsi ST, nursing and midwifery school
City
Zabol
Postal code
9861663335
Phone
+98 54 3223 0770
Fax
Email
nmasinaei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Abbas Balouchi
Position
Post Graduate Student
Other areas of specialty/work
Street address
Ferdowsi ST, Nursing and Midwifery School
City
Zabol
Postal code
Phone
+98 915 032 3586
Fax
Email
a.baluchi@zbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)