Objectives: To evaluate the effects of Rose aromatherapy on sleep quality in ccu patients. Inclusion criteria: Know the time; place ; person, the heart's ejection fraction is at least 40%,Not disturbing sleep disorders (such as migraines and arthritis);not a history of asthma; allergies to certain floral notes; not Orthopnea.Exclusion criteria: Patient is short of breath; leaves; dies; not desire to continue. The study population: Cardiac Care Unit patients، Shahid Mohammadi Hospital in Bandar Abbas on the intervention and control groups were divided randomly into two. Sample size: 60 patients (30 Control, 30 Case) .Intervention studied and time: the implementation of the study is three consecutive nights for each patient. Rose Aromatherapy is performed every night at 22 to 6 am by sleep quality Index Pittsburgh before and after, in both groups ،compare the quality of patients' sleep: sleep quality parameters including subjective sleep quality, ،sleep latency،sleep duration،habitual sleep efficiency،sleep disturbances، use of sleeping medication ،daytime dysfunction initial. The primary outcome: stimulates the central nervous system and beta-endorphin
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062628659N1
Registration date:2016-07-05, 1395/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-05, 1395/04/15
Registrant information
Name
Foroogh Ziarati
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3832 0311
Email address
foroogh.ziarati128@gmail.com
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Rosa damascene aromatherapy on sleep quality in cardiac
Care unit patients in Shahid Mohammadi Hospital in Bandar Abbas
Public title
Effect of Rosa damascene aromatherapy on sleep quality in
CCU patients in Shahid Mohammadi Hospital in Bandar Abbas
Effect of Rosa damascene aromatherapy on quality of sleeping in cardiac
Care unit patients in Shahid Mohammadi hospital in Bandar Abbas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: know the time; place ; person, the heart's ejection fraction is at least 40%,Not disturbing sleep disorders (such as migraines and arthritis);not a history of asthma; allergies to certain floral notes; not Orthopnea.
Exclusion criteria: patient is short of breath; leaves; dies; not desire to continue.
Age
No age limit
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
Street address
First Floor، Research Center، East Side of Hospital، Shahid Mohammadi Hospital، Jomhuri Eslami Boulevard، Bandar Abbas
City
Bandar Abbas
Postal code
Approval date
2016-02-04, 1394/11/15
Ethics committee reference number
HUMS.REC.1394.97
Health conditions studied
1
Description of health condition studied
Sleep Disorders and Heart Disease
ICD-10 code
G47
ICD-10 code description
Sleep Disorders
Primary outcomes
1
Description
Parameters of Sleep Quality( subjective sleep quality،sleep latency،sleep duration،habitual sleep efficiency،sleep disturbances، use of sleeping medication ،daytime dysfunction)
Timepoint
2 months
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Improve Sleep Quality
Timepoint
2 months
Method of measurement
Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Receive standard treatment prescribed by a cardiologist.
Moreover, the use of placebo
Category
Placebo
2
Description
Receive standard treatment prescribed by a cardiologist.
The use of semi-solid oil rose at the same time.
Dose: a Gram.Time use: Three consecutive nights .How use: Aromatherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital، Cardiac Care Unit
Full name of responsible person
Foroogh Ziarati
Street address
Shahid Mohammadi Hospital، Jomhuri Eslami Boulevard، Bandar Abbas
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Foroogh Ziarati
Street address
First Floor، Research Center، East Side of Hospital، Shahid Mohammadi Hospital، Jomhuri Eslami Boulvard، Bandar Abbas
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas
Full name of responsible person
Foroogh Ziarati
Position
Student
Other areas of specialty/work
Street address
Research Center، East Side of Hospital، Shahid Mohammadi Hospital، Jomhuri Eslami Boulevard، Bandar Abbas
City
Bandar Abbas
Postal code
Phone
+98 76 3333 6625
Fax
Email
foroogh.ziarati128@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Nursing، Faculty of Nursing and Midwifery، Hormozgan University of Medical Sciences، B
Full name of responsible person
Fouziyeh Mokhtari
Position
MSC
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty، Southern Resalat Street
City
Bandar Abbas
Postal code
Phone
+98 76 3366 6367
Fax
Email
f.mokhtari1391@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Foroogh Ziarati
Position
Student
Other areas of specialty/work
Street address
City
Bandar Abbas
Postal code
Phone
Fax
Email
foroogh.ziarati128@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)