Comparison of the effect of Citrus aurantium extract and Diazepam on preoperative anxiety and blood glucose in patients candidate for ophthalmic surgery
Determination of the effect of Citrus aurantium extract and oral Diazepam on Preoperative Anxiety and Blood Glucose in Patients Candidate for ophthalmic Surgery
Design
The present study is a clinical trial study with a control group with randomized single-blind parallel groups.
Sample size: In each group 35 person.
Methods: Randomize allocation is divided into three groups of 35 using block randomization.
Settings and conduct
Location: Bou Ali Sina hospital in Sari.
Method: Vital signs, blood glucose level and anxiety of patients will be assessed in three phases: 1) 8 pm. 2) 10 pm. (both in the ophthalmic surgery ward) 3) next morning 8 am. before surgery (in the operating room).
Relevant drug interventions will be performed by the nurse after the first phase and the researcher going to leave the room during interventions for blinding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patient satisfaction to participate in the study
Exclusion criteria: Patient's allergy to Citrus aurantium
Intervention groups
Group one: 100 cc of Citrus aurantium extract the night before surgery
Group two: Diazepam 5 mg tablets dissolved in 100 ml of water the night before surgery
Group three: The placebo group 100 cc distilled water the night before surgery
Main outcome variables
Anxiety; Blood sugar; vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191005044989N1
Registration date:2019-11-28, 1398/09/07
Registration timing:registered_while_recruiting
Last update:2019-11-28, 1398/09/07
Update count:0
Registration date
2019-11-28, 1398/09/07
Registrant information
Name
Meysam Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3377 5816
Email address
meysam10heidari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-11-29, 1398/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Citrus aurantium extract and Diazepam on preoperative anxiety and blood glucose in patients candidate for ophthalmic surgery
Public title
The effect of Citrus aurantium extract and Diazepam on preoperative anxiety and blood glucose of ophthalmic surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients satisfaction to participate in the study
All patients undergoing ophthalmic surgery requiring hospitalization the night before surgery
Age between 18 and 80 years
No history of diseases such as hypertension and hyperthyroidism
Allergic to Citrus aurantium
No diabetes history
Exclusion criteria:
Patients dissatisfaction to participate in the study
history of diseases such as hypertension and hyperthyroidism
Any underlying diseases affecting blood sugar and anxiety of patients such as diabetes
pregnant women
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate groups through randomized allocation, patients were divided into 3 groups. Each group included 35 individuals.
Then to equalize groups by using Block balanced randomization and the letters A and B, patients were divided into groups.
And for the Allocation concealment, the sequentially numbered, sealed, opaque envelopes was used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who collects data leaves the room during intervention (allocation and use of medication by patient) and is completely unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Mazandaran University of Medical Sciences
Street address
Research assistance, bulding number 2 of Mazandaran University of Medical Sciences, Moalem square, Sari
City
Sari
Province
Mazandaran
Postal code
۶۱۴۴۹۷۶۳۹۷
Approval date
2019-09-25, 1398/07/03
Ethics committee reference number
IR.MAZUMS.REC.1398.903
Health conditions studied
1
Description of health condition studied
Diseases associated with ophthalmic surgery like Cataract
ICD-10 code
H25.9
ICD-10 code description
Unspecified age-related cataract
2
Description of health condition studied
Diseases associated with ophthalmic surgery like Strabismus
ICD-10 code
H50.9
ICD-10 code description
Unspecified strabismus
Primary outcomes
1
Description
Anxiety score
Timepoint
Before the intervention, two hours after the intervention, and one day after the intervention.
Method of measurement
To evaluate patient's anxiety we will use Spielberger State_ Trait Anxiety Inventory questionnaire.
2
Description
The percentage of people with blood sugar above 90 mg / dL
Timepoint
Before the intervention, two hours after the intervention, and one day after the intervention
Method of measurement
To measure blood glucose level, the patient's blood sample is sent to the hospital laboratory
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Receiving 100 cc Citrus aurantium extract the night before surgery. In this study Citrus aurantium extract belong to Ghadah Kashan Company that has revenue operation license from agriculture association 3/1674, revenue operation license from ministry of health 12045 and sanitary making license 40/10882
Category
Treatment - Drugs
2
Description
Second intervention group: Diazepam 5 milligram pill dissolved in 100 ml of water the night before surgery. Diazepam pill produced by Loghman Health Pharmaceutical Company with Drug Registration Number 1228034190.
Category
Treatment - Drugs
3
Description
Placebo group receiving 100 cc distilled water the night before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bou Ali Sina medical center hospital, Sari, Mazandaran, Iran
Full name of responsible person
Hooshang Akbari
Street address
Bou Ali Sina hospital, Bou Ali Sina medical center, Pasdaran Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
۶۱۴۴۹۷۶۳۹۷
Phone
+98 11 3223 3010
Email
Meysam10heidari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
No. 140 , Amir Mazandarani Ave., Keshavarzi Blvd
City
Sari
Province
Mazandaran
Postal code
6144976397
Phone
+98 11 3448 4854
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 140 , Amir Mazandarani Ave., Keshavarzi Blvd
City
Sari
Province
Mazandaran
Postal code
6144976397
Phone
+98 11 3334 5358
Email
rezanf2002@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hooshang Akbari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 140 , Amir Mazandarani Ave., Keshavarzi Blvd
City
Sari
Province
Mazandaran
Postal code
6144976397
Phone
+98 11 4348 4857
Email
Hooshangakbari48@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Meysam Heydari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Operating room surgical technology
Street address
No. 140 , Ghaznavi Ave., Shahrdari Blvd., South Kampolo
City
Ahwaz
Province
Khouzestan
Postal code
6144976397
Phone
+98 61 3377 5816
Email
meysam10heidari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after unrecognizable people are Shareable
When the data will become available and for how long
Start of access period 8 month after publishing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Requirements for submitting a request: 1) The applicant must be affiliated with a scientific, research or academic institution.
2) The need to specify all the purposes for accessing the data.
From where data/document is obtainable
Responsive people: 1) Hooshang Akbari ( assistance professor paramedic school of Mazandaran University of Medical Sciences) Email: Hooshangakbari48@yahoo.com
2) Meysam Heydari: ( MSc student of operating room paramedic school of Mazandaran University of Medical Sciences) Email: Meysam10Heidari@gmail.com
What processes are involved for a request to access data/document
After submitting the request, the applicant will send the request via email to the above mentioned individuals and after specifying their goals for receiving the data, the information will be sent to them up to 10 days after the request.