The aim of this study is to compare the effect of Saffron with Diazepam on decreasing the anxiety before herniorhaphy . In this parallel double blind clinical trial, 60 patients whom refer to the operating room of 15 khordad hospital of Gonabad for herniorhaphy are randomly assigned into group A (Saffron :30 mg ) or B (Diazepam : 5 mg ).three hours before the operation a trained nurse wants the patient to fill out a Spilberger questionnaire and then before entering the operating room again will do it . The outcomes that will be measured are the evaluation of degree of anxiety and decreasing of it due to administering Saffron compared with Diazepam . Inclusion criteria are patients whom candidate for herniorhaphy with ASA class I and II and between 18 – 50 years old . Exclusion criteria is every ASA class except I or II . Making our research blind : the person who deliver the drug and the patient and the nurse who deliver the questionnaire are unaware from the type of the capsule that administer to the patient .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205165445N3
Registration date:2012-06-28, 1391/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-28, 1391/04/08
Registrant information
Name
Arash Hamzei
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
arash_hamzei@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Gonabad University of Medical sciences
Expected recruitment start date
2012-06-04, 1391/03/15
Expected recruitment end date
2012-12-05, 1391/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Saffron and Diazepam in decreasing of anxiety before herniorhaphy in Gonabad - 1391
Public title
Comparison of effect of Saffron and Diazepam in decreasing of anxiety before herniorhaphy in Gonabad - 1391
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1 – patients whom candidate for herniorhaphy. 2 – ASA class I and II . 3 – Age between 18 – 50
Exclusion criteria : every ASA class except I or II
Age
From 18 years old to 50 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Dr Mehdizade street, Medical University Campus, Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2011-12-10, 1390/09/19
Ethics committee reference number
90/6
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder unspecified
Primary outcomes
1
Description
preoperative anxiety
Timepoint
Before intervention and three hours past
Method of measurement
Spilberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Diazepam 5 mg and evaluation of Anxiety before and three hours later
Category
Treatment - Drugs
2
Description
Saffron 10 mg and evaluation of Anxiety before and three hours later
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
15 Khordad Hospital Beydokht, Gonabad
Full name of responsible person
Dr Arash Hamzei
Street address
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Dr. Mehdizade Street, Medical University Campus.
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Arash Hamzei
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
22 Bahman Hospital, Naser Khosro St.
City
Gonabad
Postal code
Phone
+98 53 3725 4222
Fax
Email
arash_hamzei@gmu.ac.ir; arash_hamzei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Arash Hamzei
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
22 Bahman Hospital,Naser Khosro St.
City
Gonabad
Postal code
Phone
+98 53 3725 4222
Fax
Email
arash_hamzei@gmu.ac.ir; arash_hamzei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Arash Hamzei
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
22 Bahman Hospital,Naser Khosro St.
City
Gonabad
Postal code
Phone
+98 53 3725 4222
Fax
Email
arash_hamzei@gmu.ac.ir; arash_hamzei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)