The presents study aimed to investigate The effect citrus aurantium on sleep quality hemodialysis patients. It is a clinical study and is not blinded. Inclusion Criteria: Having Consent form; Taking 5 points from Pittsburgh Sleep Quality Index ; Having experience of at least 6 month dialysis . exclusion Criteria:No tendency to continue the study; having reaction to citrus aurantium consumption. The Sample are 60 dialysis patients referring to Imam reza hospital. The intervention group(30 members) will take 3 drops of citrus aurantium with the concentration of10% every night by 3 deep breath for 4 weeks. Control group was monitored during the study and will do routine activities without any intervention. 4 weeks after the start of study the Pittsburgh Sleep Quality Index will be completed again
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2013052213423N1
Registration date:2015-08-31, 1394/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-31, 1394/06/09
Registrant information
Name
Seyed-Mousa mahdizadeh
Name of organization / entity
Faculty of nursing&midwifery mashhad university of medical scienceses
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
mahdizadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Mashhad University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of aromatherapy with Citrus aurantium
on sleep quality of hemodialysis patients
Public title
The effect Citrus aurantium
on sleep quality hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 18 to 60; Having Consent form; Taking 5 points from Pittsburgh Sleep Quality Index (PSQI); Having experience of at least 6 months dialysis ; Having full awakeness and audio visual ability for learning of citrus aurantium consumption. exclusion Criteria:No tendency to continue the study; having reaction to citrus aurantium consumption; Having renal transplant; Moving to other place or hospital or dying of patient.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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 Mashhad University of Medical Sciences
Street address
University Ave Mshhad
City
Mashhad
Postal code
9137913199
Approval date
2014-10-23, 1393/08/01
Ethics committee reference number
930052
Health conditions studied
1
Description of health condition studied
End stage renal failure
ICD-10 code
n18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention, and one month after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
The intervention group: The intervention group(30 members) will take 3 drops of Citrus aurantium with the concentration of10% every night by 3 deep breath for 4 weeks
Category
Other
2
Description
Control group: Pittsburgh Sleep Quality Index will be completed at the beginning, and 4th week. No intervention for the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS)
Full name of responsible person
Hadi Rouhi
Street address
University Avenue, Avenue Ebn-e Sina, Imam Reza hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Building Qureshi , Mashhad
City
Mashhad
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 Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Imani
Position
Master science student of Intensive Care Nursing/
Other areas of specialty/work
Street address
University Avenue, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Imanim911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousa Mahdizadeh
Position
MSc of Nursing, Lecturer, Faculty Member of Mashhad University of Medical Sciences
Other areas of specialty/work
Street address
University Avenue, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Mahdizadehm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Imani
Position
Special Nursing Graduate
Other areas of specialty/work
Street address
University Avenue, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Imanim911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)