Protocol summary

Summary
Researches have shown that nurses working in intensive care units suffer a high level of anxiety, this level of anxiety will result in not only negative effects on them, but also in decrease of the care quality and increase of the sanitary-therapeutic costs. So it seems that in case of Valerian effectiveness on reducing the anxiety, it can be recommended to the nurses and other stressful jobs as an alternative method. Accordingly, the present study will be done with the aim of determination of Valerian effectiveness on reducing the anxiety of the nurses working in intensive care units of Zanjan university of medical sciences. The study will be done through the cross sectional clinical trial for two weeks, on the nurses working in morning and evening shifts of intensive care units, who are interested in taking part in the survey. Anxiety decrease will be the main outcome variable in this study. Inclusion criteria are: Working in intensive care units at least for one month; endorsing informed consent form; not having any diagnostic physical and mental disease; not using any other sedatives or relaxant methods; having anxiety according to Speilberger´s anxiety inventory. Exclusion criteria are: Not having anxiety according to Speilberger´s anxiety inventory; pregnancy and breast feeding; outbreaking severe side effects and participantsʼ no tendency to continue the trial. Herbal Sedamin capsule contained dried roots of Valeriana Officinallis with the dose of 530 mg will be consumed by test group and placebo with the same Shape and dose by control group twice a day for one week. Speilberger's State-Trait anxiety inventory will be used to determine the participants' pre and post-test anxiety levels. Independent t-test and paired t-test will be used for data analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014042717454N1
Registration date: 2014-06-30, 1393/04/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-30, 1393/04/09
Registrant information
Name
kourosh Amini
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 243377251314
Email address
korosh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Scinces
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Valerian on nursesʼ anxiety who work in intensive care units of teaching hospitals of Zanjan university of medical sciences.
Public title
Effect of valerian on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Working in intensive care units at least for one month; endorsing informed consent form; not having any diagnostic physical and mental disease; not using any sedatives, hypnotics, barbitorates, benzodiazepines, narcotics or alcohol; getting score 20 from Speilberger´s anxiety inventory that means having anxiety; not using other relaxant methods like aromatherapy, yuga, acupuncture and so on; not being pregnant or breast feeding. Exclusion criteria: Getting score 20 and less than 20 that means not having anxiety according to Speilberger´s anxiety inventory; not using valerian or placebo during study or on the other hand not cooperating; pregnancy diagnosing; outbreaking severe side effects and participant´s no tendency to continue the trial.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
N/A
Secondary trial Id
N/A
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Ethics committtee of Zanjan university of medical sciences, Azadi Blvd, Zanjan
City
Zanjan
Postal code
Approval date
2013-10-19, 1392/07/27
Ethics committee reference number
ZUMS.REC.1392105

Health conditions studied

1

Description of health condition studied
Axiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention and one week after intervention
Method of measurement
Using the Spielberger State -Trate Anxiety inventory

Secondary outcomes

1

Description
Anxiety decrease
Timepoint
one week after begining of intervention
Method of measurement
Speilberger's anxiety inventory

Intervention groups

1

Description
Before the intervention, all the participants who were interested in taking part in the research and had the inclusion criteria, filled out the Speilberger᾿s anxiety inventory and individuals who had over twenty scores according to this inventory (the sign of anxiety existence), were included in the study. Then, the researcher gave Valerian for the test (intervention) group in the form of 530 mg gelatin covered capsules to take one every morning and night for a week. Whereas ,according to the pharmacognosy resources, the Valepotriates in Valerian - effective components in anxiety reduction- are from Iridoids which are unstable compounds; Sedamin capsules were used in this study which contained dried root and risome powder of Valeriana Officinalis, produced by Esfahan Goldaroo company which is more stable in comparison with its other drug forms and standardization procedure is completed by the mentioned company. While in many studies, the extract or a combination of extract and root powder was used with no distinct standardization and stability rate.
Category
Treatment - Drugs

2

Description
The control group was given the placebo with the same shape, taste, size and period of consumption as Valerian capsules. Regarding the distinct and specific odor of Valerian, Valerian and placebo capsules were stored together separated by a mesh lining, at least for two weeks. All the placebo production and preparation procedure was completed in the pharmaceutics laboratory of the development center for pharmaceutical products technology units dependent on Tehran university of medical sciences; in this laboratory, ineffective lactose powder was used to fill the placebo capsules. Personal and telephonic follow ups were done by the researcher in order to make sure of participants᾿ drug consumption and the probable side effects investigation. At the end of the period, Speilberger᾿s anxiety inventory was filled out again by the two groups. Questionnaires were gathered and primary and secondary data were analyzed. No payment or premium was received by the participants in this study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mousavi specialized training and treatment center
Full name of responsible person
Kourosh Amini
Street address
Mousavi specialized training and treatment center, Gavazang Rd, Zanjan
City
Zanjan

2

Recruitment center
Name of recruitment center
Valiasr training and treatment center
Full name of responsible person
Kourosh Amini
Street address
Valiasr training and treatment center,After Valiasr Sq, Zanjan
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Scinces
Full name of responsible person
Dr. Mohammad Masoud Vakilli
Street address
Vice chancellor for research, Zanjan university of medical sciences, Azadi Blvd, Zanjan
City
Zanjan
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, Zanjan University of Medical Scinces
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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Kourosh Amini
Position
Assistant Professor/Phd
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Parvin Etesami St, Zanjan
City
Zanjan
Postal code
4515789589
Phone
+98 24 3377 2513
Fax
+98 24 3377 0305
Email
korosh@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Kourosh Amini
Position
PhD
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Parvin Etesamie St, Zanjan
City
Zanjan
Postal code
4515789589
Phone
+98 24 1727 2517
Fax
+98 24 3377 0305
Email
korosh@zums.ac.ir; korosh_amini@yahoo.com
Web page address
www.zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Masoomeh Najafzadeh
Position
Master of science
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Parvin Etesami St, Zanjan
City
Zanjan
Postal code
1376757987
Phone
+98 21 6622 5434
Fax
Email
masoomeh_najafzadeh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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