This study is a quasi – experimental research which is a kind of randomized clinical trial. The population is the patients who hospitalized in dialysis centers of Akhavan hospital in Kashan and Shohadaye Lenjan hospital in Zarrin Shahr. After obtaining written consent from patients, sampling should be done continuously and purposefully, and eligible individuals, after inclusion, randomly divided into intervention group or control group. Intervention group is the group who exposed of two drops of pure lavender oil which dripped on a cotton ball, and pinned to patients’ collar every night for seven nights. There is no intervention for control group. In this study, data collection is demographic questionnaire and Pittsburgh sleep quality index questionnaire (PSQI). Before intervention, demographic form and Pittsburgh sleep quality index will be completed for both groups control and intervention. In intervention group, before and after intervention (end of the first week), Pittsburgh sleep quality questionnaire will be completed. In control group, Pittsburgh sleep quality will also be completed matched with the intervention group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042111572N2
Registration date:2013-05-23, 1392/03/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-23, 1392/03/02
Registrant information
Name
Zahra Najafi
Name of organization / entity
Kashan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
najafi-za@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-06-05, 1392/03/15
Expected recruitment end date
2013-07-06, 1392/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of aromatherapy on Sleep Quality of Patients Undergoing Hemodialysis in zarrin shahr Dialysis Center and Akhavan hospital kashan in 2013.
Public title
The Effect of aromatherapy on Sleep Quality of Patients Undergoing Hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having the age of minimum 18 and maximum 70; Agreement for attending in the study; Hemodialysis history for at least 6 months; Performing hemodialysis at least 2 times in a week and every time at least 3 hours; Being consciousness and no hearing and speech impaired (known); No history of allergic rhinitis, eczema or known respiratory problems such as asthma and lack of olfactory dysfunction; Not suffering from known mental illness; No drug addiction
Exclusion criteria: Suffering from severe physical crisis, acute illness, hospitalization and surgery; Suffering from mental crisis, bereavement and divorce; Traveling; Lack of cooperation during the study; Patient decease; Allergic to the smell of lavender; Non-performing aromatherapy less than 3 times a week for any reason.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Kashan University of Medical Sciences
Street address
Kashan, Ravandi Ghotb Boulevard
City
Kashan
Postal code
Approval date
2013-04-23, 1392/02/03
Ethics committee reference number
577/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Sleep disorders in hemodialysis patients
ICD-10 code
N18.9
ICD-10 code description
Chronic renal failure, unspecified
Primary outcomes
1
Description
Quality of sleep
Timepoint
A week
Method of measurement
Pittsburgh sleep quality index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: Interventiongroup is the group who exposed of two drops of pure lavender oil. which dripped on a cotton ball, and pinned to patients’ collar every night for seven nights.
Category
Other
2
Description
Intervention: There is no intervention for control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
dialysis centers of Shohadaye Lenjan hospital
Full name of responsible person
Zahra Najafi
Street address
Kashan University of Medical Sciences
City
Zarrin Shahr
2
Recruitment center
Name of recruitment center
Akhavan hospital
Full name of responsible person
Zahra Najafi
Street address
Kashan University of Medical Sciences
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zahra Najafi
Position
Graduate student critical care nursing
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
87155/111
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
zahranajafi90@yahoo.comzahranajafi90@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Najafi
Position
Graduate student critical care nursing
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
87155/111
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
zahranajafi90@yahoo.comzahranajafi90@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Najafi
Position
Graduate student critical care nursing
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
87155/111
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
zahranajafi90@yahoo.comzahranajafi90@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)