The aim of this study is to compare the effect of Safranal with Diazepam on decreasing the anxiety before surgery in 6mounth in 2013 . In this parallel double blind clinical trial, 60 patients whom refer to the operating room of 15 khordad hospital of Gonabad for Varicocel are randomly assigned into group A (Safranal :15 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 . Patients' vital signs will be recorded. The outcomes that will be measured are the evaluation of degree of anxiety and decreasing of it due to administering Safranal compared with Diazepam . Inclusion criteria : 1 – patients whom candidate for Varicocel. 2 – ASA class I and II. 3 – Age between 18 – 50 Exclusion criteria : 1- every ASA class except I or II, 2 - Not wanting to participate in research, 3 - Participants whom were allergic to saffron. 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:IRCT201304255445N4
Registration date:2013-09-22, 1392/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
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
2013-03-20, 1391/12/30
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Safranal and Diazepam in decreasing of anxiety before surgery
Public title
Comparison of effect of Safranal and Diazepam in decreasing of anxiety before surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1 – patients whom candidate for Varicocel. 2 – ASA class I and II . 3 – Age between 18 – 50 Exclusion criteria : 1- every ASA class except I or II, 2-Not wanting to participate in research, 3-Participants whom were allergic to saffron.
Age
From 18 years old to 50 years old
Gender
Male
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
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, University campous Gonabad Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
92/2/1/ک الف
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
Intervention group: Safranal 15 mg and evaluation of Anxiety before and three hours later
Category
Treatment - Drugs
2
Description
Control group: Diazepam 5 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
Gonabad, Beydokht
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, University campous Gonabad Gonabad
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
Naser khosro st, 22Bahman Hospital.
City
Gonabad
Postal code
Phone
+98 53 3723 1112
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
22Bahman Hospital – Gonabad, Naser khosro st
City
Gonabad
Postal code
Phone
+98 53 3723 1112
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
22Bahman Hospital – Gonabad, Naser khosro st
City
Gonabad
Postal code
Phone
+98 53 3723 1112
Fax
Email
arash_hamzei@gmu.ac.ir; arash_hamzei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)