Evaluation of the effect of crocus sativus tea on anxiety level of nurses working in intensive care units
Design
Clinical trial with control group, with parallel groups, double-blind, randomized on 100 patients. For randomization, software for generating random numbers using a block method called Sealed Envelope has been used.
Settings and conduct
This research is a randomized controlled clinical trial that will be performed in intensive care units of Amirkabir Arak hospital on nurses who have continuous shifts. Block randomization method with 6 blocks of 4 is used to allocate the samples. People are assigned to two groups of 34. Every day for 40 days, the researcher gives tea containing saffron and water to the intervention group and placebo containing water and two drops of saffron essential oil to the control group. At the beginning and end of the study, the nurses of both groups completed the demographic questionnaire and the Spiel Berger questionnaire. Based on this, the anxiety level of nurses is determined. Then, in the end, the average of obvious anxiety between the two intervention and control groups is compared. The data analyzer and participants will not know how the samples are placed in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nurses who attend the ward only for 175 hours per month, Not taking any sedative and anti-anxiety drugs؛ Exclusion criteria: Unwillingness to participate in the study, Allergic to saffron
Intervention groups
Intervention group: At the beginning of the shift, nurses consume herbal tea containing 100 mg of saffron and 100 ml of water daily for 40 days. Control group: Nurses in the control group take a placebo containing 100 ml of water and two drops of saffron essential oil daily at the beginning of their shift for 40 days.
Main outcome variables
Anxiety level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051142N4
Registration date:2022-10-26, 1401/08/04
Registration timing:registered_while_recruiting
Last update:2022-10-26, 1401/08/04
Update count:0
Registration date
2022-10-26, 1401/08/04
Registrant information
Name
Aida Arjloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
golmehrsherafati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2022-11-11, 1401/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of crocus sativus tea on anxiety level of nurses working in intensive care units
Public title
Evaluation of the effect of crocus sativus tea on anxiety level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses who attend the ward only for 175 hours per month (mandatory hours).
Not taking any sedative and anti-anxiety drugs
Exclusion criteria:
Unwillingness to participate in the study
Allergic to saffron
Complications caused by the consumption of saffron
The presence of any underlying disease
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Nurses are divided into an intervention group and a control group based on the order of entry and the randomization sequence that is established in advance. The sequence is unpredictable and the arrangement is completely random. To allocate the samples, the block randomization method with the size of 6 blocks of 4 blocks will be used, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for two groups. At first, the sequence ABAB, ABBA, BBAA, BABA, BAAB, AABB is produced, then randomly and by placing among the blocks, a block is selected and the arrangement pattern in that block will be used to allocate nurses, then this block is placed in the main container and Another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Double blinded
Blinding description
The data analyzer and participants will not know how the samples are placed in the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak university of medical sciences
Street address
Arak university of medical sciences, Basij Sq., Sardasht region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.ARAKMU.REC.1401.064
Health conditions studied
1
Description of health condition studied
Anxiety level
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety rate
Timepoint
Before the intervention and 40 days after the start of the first intervention, the anxiety level of each patient is measured.
Method of measurement
At the beginning and end of the study, the demographic questionnaire and the Spiel Berger questionnaire were completed by the nurses of both groups and based on this, the anxiety level of nurses is determined.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group is given tea containing 100 mg of saffron and 100 ml of water for 40 days. At the beginning of the study, demographic questionnaire and Spiel Berger questionnaire are completed by nurses. Based on the response to the Spiel Berger questionnaire, the level of primary anxiety of nurses is determined. Then, at the end of 40 days, the Spiel Berger questionnaire is completed again by the nurses, and all the dependent variables of the research are checked at the beginning and the end of the study, and according to the articles that have measured the level of anxiety with the Spiel Berger questionnaire, in this study, the level Overt anxiety is checked.
Category
Other
2
Description
Control group: The control group was given a placebo containing 100 ml of water and two drops of saffron essential oil to flavor the water in such a way that it cannot be identified with the tea containing saffron for 40 days. The essential oil used was prepared by Magnolia Company, which is the largest company in the production of flavorings and essential oils in Iran, which started its activity in 2013. At the beginning of the study, demographic questionnaire and Spiel Berger questionnaire are completed by nurses. Based on the response to the Spiel Berger questionnaire, the level of primary anxiety of nurses is determined. Then, at the end of 40 days, the Spiel Berger questionnaire is completed again by the nurses, and all the dependent variables of the research are checked at the beginning and the end of the study, and according to the articles that have measured the level of anxiety with the Spiel Berger questionnaire, in this study, the level Overt anxiety is checked.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Mahbobeh Sajadi
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 918 599 7635
Email
golmehrsherafati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza Kamali
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 918 599 7635
Email
golmehrsherafati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
80
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
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the part of the data related to the original outcome will be able to be shared.
When the data will become available and for how long
since the winter of 2023
To whom data/document is available
Researchers and students in this field
Under which criteria data/document could be used
In order to reduce the level of anxiety of the medical staff
From where data/document is obtainable
Vice chancellor for education and research, Arak university of medical sciences
What processes are involved for a request to access data/document
These documents will be available on the website of Arak university of medical sciences.