In a randomized double blind clinical trial 70 patients aged 15 -65 years old ASA I and II group, after obtaining consent, will be entered into study and are randomly assigned into two groups: 35 patients (group 1 receiving Borage and group 2 receiving diazepam). A similar method is used for anesthesia premedication. Study medications are administered orally 6 hours before anesthesia (to prevent disclosure to the patient and evaluation of the capsules, the capsules prepared in the laboratory and will be presented with a similar appearance). Information is recorded by the anxiety questionnaire and demographic data and vital signs before and 6 hours after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110237875N1
Registration date:2012-04-18, 1391/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Hossein Rahmani
Name of organization / entity
Ahvaz jondishapour university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1444 2865
Email address
rahmani.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2012-04-15, 1391/01/27
Expected recruitment end date
2012-08-15, 1391/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effects of Echium amoenus and diazepam for reducing preoperation anxiety before orthopedic surgery
Public title
Comparison between effects of Echium amoenus and diazepam for reducing preoperation anxiety before orthopedic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion critria: patients aged 15 to 65 years old in ASA groups one and two and are candidated for orthopedic surgery.
Exclusion criteria: dissatisfaction; history of mental illness; history of drug or a particular plant (diazepam or Borage) allergy; pregnant women and mothers in lactation
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz jondishapour university of medical sciences Ethics Committee
Street address
Ahvaz jondishapour university of medical sciences
City
Ahvaz
Postal code
Approval date
2012-04-07, 1391/01/19
Ethics committee reference number
Eth-91s01
Health conditions studied
1
Description of health condition studied
Preoperative anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Six hours after intervention
Method of measurement
Beck questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control: Diazepam 2 mg capsule once during the study will receive
medications are administered orally 6 hours before anesthesia
Category
Treatment - Drugs
2
Description
Intervention: 500 mg capsules of borage and once during the study will receive
medications are administered orally 6 hours before anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz jondishapour university of medical sciences
Full name of responsible person
Vice chancellor for research
Street address
Ahvaz jondishapour university of medical sciences. ahvaz. iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz jondishapour 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
Ahvaz jondishapour university of medical sciences
Full name of responsible person
Hossein Rahmani
Position
Student of anesthesia
Other areas of specialty/work
Street address
Department of paramedical Sciences, Ahvaz jondishapour university of medical sciences
City
Ahvaz
Postal code
Phone
+98 61 1444 2865
Fax
Email
r.h1989@yahoo.comrahmani.h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz jondishapour university of medical sciences
Full name of responsible person
Hossein Rahmani
Position
Student of anesthesia
Other areas of specialty/work
Street address
Ahvaz jondishapour university of medical sciences
City
Ahvaz
Postal code
Phone
+98 61 1444 2865
Fax
Email
r.h1989@yahoo.com; rahmani.h@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Hossein Rahmani
Position
student of anesthesiology/ leader of study
Other areas of specialty/work
Street address
Department of paramedical Sciences, Ahvaz Jondishapour University of Medical Sciences
City
ahwaz
Postal code
Phone
Fax
Email
r.h1989@yahoo.comrahmani.h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)