The main treatment of CRF patients is hemodialysis which can cause numerous psychosocial problems for them. Anxiety is the most common problem of these patients today. This is randomized clinical trial. The aim of the current study is to assess the effect of Rose water aroma on anxiety of hemodialysis patients. This study is done on 50 hemodialysis patients in Vali Asr hospital in Birjand, Iran who have inclusion criteria. 50 patients will be randomly divided into 2 groups (intervention group & control group). Inclusion criteria: at least 2 time hemodialysis weekly; at least 6 months hemodialysis background; having no acute stressor in 6 months later and no anti anxiety drug use and no breath and smell problems. Exclusion criteria: by each reason that can cause patient miss to join in survey (kidney transplant, coma, death ...), consent to continue study. Intervention group will breathe 3 gtt Rose- water before sleep every night and before hemodialysis time for 4 weeks and in the control group will be no intervention. Shpilburger standard instrument will be use to evaluate intervention and control groups anxiety at the end of second and fourth Weeks. The gathered data will be analyzed by spss software in significant level of p<0.05.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052613476N1
Registration date:2013-08-12, 1392/05/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-12, 1392/05/21
Registrant information
Name
Farzaneh Barati
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 3041
Email address
farzanehb86@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-06-17, 1392/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Rose water(Rosa damascene) Aroma on anxiety of hemodialysis patients
Public title
Effect of Rose water Aroma on anxiety of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least 2 time hemodialysis weekly; at least 6 months hemodialysis background; having no acute stressor in 6 months later and no anti anxiety drug use and no breath and smell problems.
Exclusion criteria:by each reason that can cause patient miss to join in survay (kidney transplant , coma ,death ...) , consent to continue study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Birjand University of Medical Sciences
Street address
South Khorasan, Birjand,Ghaffari St, Birjand University of Medical Sciences
City
birjand
Postal code
379-97175
Approval date
2013-05-05, 1392/02/15
Ethics committee reference number
92-02-02
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention, end of the second week and at the end of the fourth week
Method of measurement
Spilberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will breath 3 gtt Rose- water before night sleep and before hemodialysis for 4 week. In the control group will be no intervention
Category
Treatment - Drugs
2
Description
Control group: in the control group will be no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Street address
Ghaffari st
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzadeh
Street address
Ghaffari st
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Farzaneh Barati
Position
Master of nursing
Other areas of specialty/work
Street address
Ghaffari st
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
farzanehb86@bums.ac.ir; farzanehb86@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Farzaneh Barati
Position
Master of nursing
Other areas of specialty/work
Street address
South Khorasan, Birjand, Birjand University of Medical Sciences
City
Birjand
Postal code
379-97175
Phone
+98 56 1444 3041
Fax
+98 44 30076
Email
farzanehb86@yahoo.com; farzanehb86@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Farzaneh Barati
Position
Master of nursing
Other areas of specialty/work
Street address
South Khorasan, Birjand, Birjand University of Medical Sciences
City
Birjand
Postal code
379-97175
Phone
+98 56 1444 3041
Fax
+98 56 1443 0076
Email
farzanehb86@yahoo.comfarzanehb86@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)