The aim of this study was the effect of Rose damascenes extracts on anxiety rate and sleep quality. In this randomized clinical trial, 90 patients were randomly allocated to two groups: intervention and control group (45 patients in each group).The study will be conducted on cardiac patients hospitalized in CCU of Rajaee hospital in Karaj. In both groups at the first day of admonition, Sent merry sleep questioner and Espiel berger questioner for anxiety will be completed then in intervention group 24 hours before angiography( every 8 hours,15drop Rose damascene extract) and in control group 24 hours before angiography ( every 8 hours,15drop placebo)will be given. In the morning of angiography day in both groups, both questioners will be completed. This clinical trial is double blind and scholar and patient are unaware about drops contents.
General information
Acronym
IRCT registration number
IRCT registration information
IRCT registration number:IRCT2015112425221N1
Registration date:2016-02-02, 1394/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-02, 1394/11/13
Registrant information
Name
soodabeh Babaee
Name of organization / entity
school of nursing and midwifery Ardabil
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 6085
Email address
so.babaee@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardebil University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosa damascene extract on anxiety rate and sleep quality candidate angiography:A double-blind randomized controlled trial
Public title
The effect of Rosa damascene extract on anxiety rate and sleep quality, candidate angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion / Exclusion: Inclusion criteria: age above 18 years with cardiac disease, candidate angiography, absence of angiography history and in their family, literacy, signing the informed consent sheet, absence of anxiety and sleep disorders, alert patients, at least 24, hours hospitalization .Exclusion criteria: Asthma and allergy history, using complementary medicine in recent week, using sedative and hypnotic medicine, critical ill and cancellation of work.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University
Street address
Ardabil,medical science university,Pardis office ,university square,end of university avenue
City
Ardabil
Postal code
5618985991
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
IR.ARUMS.REC.1394046
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
anxiety NOS
2
Description of health condition studied
sleep quality
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention,before angiogeraphy
Method of measurement
Eshpilberger questioner
2
Description
sleep quality
Timepoint
The night before and after intervention
Method of measurement
sent merrys hospital sleep questioner
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, Damascene Rose extract in oral drop, Construction Barij Essence Pharmaceutical Company(every 8 hours,15 drop with a little of water will be given.
Category
Treatment - Drugs
2
Description
In control group, placebo in oral drop form, every 8 hours, 15drop with a little of water will be given. Placebo is similar to extract and it is made by Barij Essence Pharmaceutical Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee educational Hospital Alborz university of medical science karaj. Iran