The aim of this study was to compare the anti-anxiety effect of cardamom with oral diazepam on preoperative anxiety in patients undergoing orthopedic surgery in Imam Ali Hospital in Bojnourd.
Design
The present study Will be a randomized, one blind, clinical trial of 48 patients (16 Cardamom Extract, 16 oral diazepam and 16 control group) undergoing orthopedic surgery in Imam Ali Hospital in Bojnourd. Patients will initially assessed for inclusion criteria and Exclusion criteria.Then, eligible patients are selected by available sampling method and will be randomly assigned to three groups using the random number table.
Settings and conduct
The present study Will be a randomized, one blind, clinical trial of 48 patients (16 Cardamom Extract, 16 oral diazepam and 16 control group) undergoing orthopedic surgery in Imam Ali Hospital in Bojnourd.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of mental illness; non-use of psychiatric and psychosocial drugs; sedative drugs; non-use of narcotic and absence of acute and chronic disease; Exclusion criteria: Use of anti-anxiety or sedative after the start of the study; and dissatisfaction with the presence of the study
Intervention groups
The night before the surgery, the patients in the Cardamom Extract group will receive 10 drops (equivalent to 250 mg) of Cardamom Extract, dissolved in 50 cc of urban water, the diazepam group also will receive 5 mg oral diazepam tablets plus 50 cc of urban water and the control group will receive only 50 cc of urban water
Main outcome variables
The level of anxiety of the patients at 21 o'clock, one night before surgery will assessed by the researcher's assistance (researcher's assistance will be unaware to the intervention and control groups) for pretest and one hour before the operation begins Surgery for the post-test will be measured with the Spielberg tool.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170921036302N1
Registration date:2017-12-26, 1396/10/05
Registration timing:retrospective
Last update:2017-12-26, 1396/10/05
Update count:0
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
sadigheh Khalili Shomia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8328
Email address
khalilis@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
2017-10-02, 1396/07/10
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
empty
Scientific title
Compare the anti-anxiety effect of cardamom with oral diazepam on preoperative anxiety in patients undergoing orthopedic surgery
Public title
The anti-anxiety effect of cardamom with oral diazepam on preoperative anxiety in patients undergoing orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are awake
Anesthesia risks class 1 and 2 of the American Society for Anesthesiology (ASA)
Have no history of mental illness
Lack of psychiatric, sedation drugs and narcotics
Non-acute and chronic illness.
Exclusion criteria:
Taking anti-anxiety or sedation after the onset of the study
Dissatisfaction with the presence of the study
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
0
Actual sample size reached:
48
More than 1 sample in each individual
Actual sample size in each individual:
0
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples are divided into three groups using random allocation method and random numbers will be used for random allocation of the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The level of anxiety of the patients at 21 o'clock, one night before surgery will assessed by the researcher's assistance (researcher's assistance will be unaware to the intervention and control groups) for pretest and one hour before the operation begins Surgery for the post-test will be measured with the Spielberg tool.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
ir.medsab.rec.1396.42
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Mental and behavioural disorders
Primary outcomes
1
Description
Anxiety of patients before orthopedic surgery
Timepoint
At 21 o'clock, one night before surgery and one hour before the surgery begins
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The night before the surgery, the patients in the Cardamom Extract group will receive 10 drops (equivalent to 250 mg) of Cardamom Extract, dissolved in 50 cc of urban water.
Category
Treatment - Drugs
2
Description
The diazepam group also will receive 5 mg oral diazepam tablets plus 50 cc of urban water.
Category
Treatment - Drugs
3
Description
and the control group will receive only 50 cc of urban water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital in Bojnourd
Full name of responsible person
Doctor Javad Shahinfar
Street address
Imam Ali Hospital, Payam Noor University Street, Chamran street
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
sahba.d59@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Docto Fereshteh Ghorat
Street address
Collegiate Paradise, Sabzevar Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8303
Email
shomia@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sadigheh Khalili Shomia
Position
Master of Science in Nursing, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8328
Fax
Email
shomia@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sadigheh Khalili Shomia
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8328
Fax
Email
shomia@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sadigheh Khalili Shomia
Position
Master of Science in Nursing, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8328
Fax
Email
shomia@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available