Protocol summary

Study aim
The main goals: Comparison of the effect of Valerian Consumption in different Courses on anxiety, stress and depression of employed midwives
Design
A clinical trial with a control group, With parallel groups, Double-blind، Accidental
Settings and conduct
This study is a double-blind clinical trial. It will be done on 80 Employed Midwives in hospitals and health Centers in Khorramabad city that have mild to moderate depression, anxiety, stress.Participants were randomly divided into intervention (drug) and placebo groups.In the intervention group 530mg of Valerian capsules (manufactured by Flower medicine Company) is given twice daily for one month.In the control group, placebo was given a 530 mg capsule by the same method.Dass21 questionnaire and Demographic questionnaire was used for data collection.Results will be compared one week and one month after the intervention.
Participants/Inclusion and exclusion criteria
Midwives working in hospitals or health centers that meet the inclusion criteria are randomly selected in two groups. Inclusion criteria:1-No use of sedatives and Hypnotic 2- Having mild to moderate anxiety 3- No known mental illness. Exclusion criteria:1-Failure to complete the questionnaire and daily and timely consumption of Valerian capsule 2-pregnancy.
Intervention groups
Intervention group (drug): 530 mg Saddam's capsule (Valerian root) twice daily for one month Placebo group: 530 mg twice daily capsule for one month
Main outcome variables
Depression; anxiety; stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130211012440N7
Registration date: 2019-09-06, 1398/06/15
Registration timing: prospective

Last update: 2019-09-06, 1398/06/15
Update count: 0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Ziba Taghizade
Name of organization / entity
Tehran University of Medical Sciences school of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 4694
Email address
taghizad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative Study of Valerian consumption in different course on anxiety stress and depression of employed midwives
Public title
Effect of Valerian on depression, anxiety, stress of employed midwives
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: 1-No use of sedatives and Hypnotic 2- Having mild to moderate anxiety 3- No known mental illness.
Exclusion criteria:
Exclusion criteria: 1-Failure to complete the questionnaire and daily and timely consumption of Sedamin's capsule 2-pregnancy.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this method we will have two types of capsules called a and b.The blocking will be four.Capsules a and b will be grouped together in six models.We will give each of the six states a hypothetical number. We'll have a list of clip modes with hypothetical numbers.We'll make cards that write hypothetical numbers 1 to 6 on it. We take it randomly the cards on which the hypothetical numbers are written.Then we will give the capsules a and b based on the pre-arranged list.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher and the participants did not know the type of capsule they received (placebo-drug).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran Univercity of Medical science
Street address
Tehran Univercity of Science, keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-08-23, 1398/06/01
Ethics committee reference number
IR.TUMS.VCR.REC.1398.507

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

2

Description of health condition studied
depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes

3

Description of health condition studied
stress
ICD-10 code
Z56.6
ICD-10 code description
Other physical and mental strain related to work

Primary outcomes

1

Description
Depression Score
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Dass_21 Questionnaire

2

Description
anxiety score
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Dass_21 Questionnaire

3

Description
Anxiety Score
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Dass_21 Questionnaire

4

Description
sress score
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Dass_21 Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: (530 mg Valerian capsule) containing the roots of Valerian (manufactured by Flower Drug Company) purchased in Iran 2 times daily for one month.
Category
Treatment - Drugs

2

Description
Control group: Placebo in the form of 530 mg capsule twice daily for one month for one month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
helth center in khorram abad
Full name of responsible person
Syede faze Hashemi nezhad
Street address
Khorram Abad, above Anushirvan Square
City
Khorram Abad
Province
Lorestan
Postal code
1234567890
Phone
+98 66 3323 9941
Email
65136513ff@gmail.com

2

Recruitment center
Name of recruitment center
Hospitals of Khorram abad
Full name of responsible person
Syede faze Hashemi nezhad
Street address
Khorram Abad, Moallem Street, Anooshirvan Square
City
Khorram Abad
Province
Lorestan
Postal code
1234567890
Phone
+98 66 3330 0661
Email
65136513ff@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Nikbakht Nasrabadi
Street address
Vice Chancellor for Research,Tehran University of Medical Sciences. Ghods St. Keshavarz Bv
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6693 3600
Email
fnm@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
syede faeze hashemi nezhad
Position
Master of Midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
First floor, No. 21, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Email
56136513ff@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizade
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Email
taghizad@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
syde faeze hashemi nezhad
Position
Masters of Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Email
65136513ff@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Insufficient information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Loading...