A single-blind clinical trial that aims to compare the efficacy of preoperative anxiety sweating orange blossom water and oxazepam tablets 66 patients undergoing non- emergent coronary artery bypass graft aged 65_40 years and martyr Namazi Hospital in Shiraz faqih be done will . Three days before surgery and the morning of surgery , blood pressure and heart rate will be measured and the Spielberger state anxiety questionnaire will be completed by the researcher . .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010516080N1
Registration date:2014-02-28, 1392/12/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-28, 1392/12/09
Registrant information
Name
Khadige Dehghan
Name of organization / entity
Yazd University Of Medical Scences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
dehghan_kh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Yazd University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of Citrus aurantium and oxazepam tablets on preoperative anxiety in coronary artery bypass graft surgery candidates
Public title
Comparison of Citrus aurantium and oxazepam tablets on preoperative anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with non-urgent transplant candidates for coronary artery disease 65_40 age, dating to the Persian language and literacy, reading and writing, the patient is fully alert. Exclusion criteria: Patients with a history of previous surgery, patients with a history of coronary artery bypass graft surgery. close relatives, patients who have unstable physical conditions, patients with mental illness - nervous and anxiety disorders, patients with a history of using anti-anxiety drugs and sedatives; patients with malignancy, medical and paramedical staff, patients on dialysis.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University Of Medical Sciences
Street address
Iran, Yazd, Shahid Sadoughi University Of Medical Sciences
City
Yazd
Postal code
8916978477
Approval date
2013-09-01, 1392/06/10
Ethics committee reference number
17/1/104946/پ
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40
ICD-10 code description
Phobic Anxiety Disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Before And 3 Day After Intervention
Method of measurement
Spilberger Anxiety Questionnare
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before And 3 Aay After Intervention
Method of measurement
With Pressure MeterAnd With Milimeter HG
2
Description
Heart Rate
Timepoint
Before And 3 Day After Intervention
Method of measurement
Beat Per Minute
Intervention groups
1
Description
In patients receiving Citrus aurantium three days before surgery until the day before the operation, the daily two hours after lunch take Citrus aurantium 10 cc orally.
Category
Treatment - Drugs
2
Description
To patients receiving oxazepam tablets, one tablet of oxazepam 10 mg orally given in the evening before surgery .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
namazi hospital
Full name of responsible person
Dehghan Khadije
Street address
Iran, Yazd, Shahid Sadoughi University Of Medical Sciences
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Dehghan Khadije
Street address
Iran, Yazd, Shahid Sadoughi University Of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University Of Medical Sciences
Full name of responsible person
Dehghan Khadije
Street address
Iran, Yazd, Shahid Sadoughi University Of Medical Sciences
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University Of Medical Sciences
Full name of responsible person
Dehghan Khadije
Position
Student Of Critical Care Nursing
Other areas of specialty/work
Street address
Iran, Yazd, Shahid Sadoughi University Of Medical Sciences
City
Yazd
Postal code
8916978477
Phone
+98 35 1724 0171
Fax
+98 35 1725 4750
Email
dehghan.kh.lar@gmail.com
Web page address
www.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University Of Medical Scinces
Full name of responsible person
Dehghan Khadije
Position
STUDENT of CRITICAL care Nursing
Other areas of specialty/work
Street address
Iran, Yazd, Shahid Sadoughi University Of Medical Sciences
City
Yazd
Postal code
8916978477
Phone
+98 35 1724 0171
Fax
+98 35 1725 4750
Email
dehghan_kh@ssu.ac.is
Web page address
www.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University Of Medical Sciences
Full name of responsible person
Dehghan Khadije
Position
Student Of Critical care nursing
Other areas of specialty/work
Street address
Iran, Yazd, Shahid Sadoughi University Of Medical Sciences
City
Yazd
Postal code
8916978477
Phone
+98 35 1724 0171
Fax
+98 35 1725 4750
Email
dehghan.kh.lar@gmail.com
Web page address
www.ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)