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The effect of Salvia Officinalis tea on the sleep quality of Students Living in Dormitories

Protocol summary

Study aim
Determining the effect of sage tea on sleep quality of medical students.
Design
This study is a clinical trial with a control group, with parallel groups, two-way blind, easily randomized, on 128 students living in dormitories of Iranshahr University of Medical Sciences. Excel software rand function was used for randomization.
Settings and conduct
First, the list of students living in the dormitories of Iranshahr University of Medical Sciences is extracted. A code room is provided for each student. In a simple random method based on the room (there is a possibility of using roommates from each other), using the software are divided into experimental and control groups. The intervention group was given bags containing sage The control group will be given bags containing brown sugar placebo. it is necessary to mention boxes and bags of tea will not differ in appearance, tea boxes are numbered by a third party who knows the contents at the bottom. The researcher then delivers boxes of the same number to the students in a room. In addition, researchers and participants will not have information about the main drink and placebo
Participants/Inclusion and exclusion criteria
No history of underlying disease, no history of mourning in the last 6 months, no history of hospitalization, no use of psychiatric drugs, no participation in counseling class Score 5 or more from the "Pittsburgh Sleep Quality Index", no history of allergies to herbs, unwillingness to continue cooperation, no use of sage for three nights, pregnancy, lactation
Intervention groups
The intervention group, who are medical students living in dormitories, were given bags containing Salvia Officinalis The control group, who are medical students living in dormitories, will be given bags containing brown sugar placebo
Main outcome variables
quality of students' sleep

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141125020082N2
Registration date: 2021-11-07, 1400/08/16
Registration timing: prospective

Last update: 2021-11-07, 1400/08/16
Update count: 0
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
Masoome Shahnavazi
Name of organization / entity
Iranshahr University Of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 54 3721 0481
Email address
mshahnavazi1392@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Salvia Officinalis tea on the sleep quality of Students Living in Dormitories
Public title
1- The effect of salvia officinalis tea on the sleep quality of Students Living in Dormitories of Iranshahr University of Medical Sciences, 2021.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
No diseases such as diabetes, epilepsy, hypotension, kidney and liver problems No history of mourning in the last 6 months No hospitalization in the last 6 months Do not take certain medications such as anti-depressant, anti-anxiety and hypnotic Not participating in counseling classes with psychologists Score 5 or more on the "Pittsburgh Sleep Quality Index" Lack of sensitivity to medicinal plants
Exclusion criteria:
Reluctance to continue cooperation Do not use Salvia Officinalis tea for three nights Unfortunate events (death of loved ones, divorce of parents and accident) Getting sick and hospitalized Pregnancy Breastfeeding
Age
From 18 years old to 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Among the six student dormitories at Iranshahr University of Medical Sciences, students with sleep quality disorders are identified through a pre-test and then given a code to the rooms where students with sleep disorders meet the inclusion criteria and consent to participate in the study. To be. Using the random numbers software version CF-1.7.1, the rooms where students live are divided into two groups of test and control (it is possible to use roommates from each other).
Blinding (investigator's opinion)
Double blinded
Blinding description
Boxes and bags of tea will not differ in appearance, tea boxes are numbered by a third party who knows the contents at the bottom. The researcher then delivers boxes of the same number to the students in a room. In addition, researchers and participants will not have information about the main drink and placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iranshahr University of Medical Sciences
Street address
Balooch St.
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.IRSHUMS.REC.1400.012

Health conditions studied

1

Description of health condition studied
Sleep Disorder
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition

Primary outcomes

1

Description
Salvia Officinalis may improve the quality of students' sleep
Timepoint
Students' quality score according to the "Pittsburgh Sleep Quality Index" should be below six
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group brews ten grams of sage and receives it every night, before going to bed for a month
Category
Other

2

Description
Control group:Control group: This group of placebo, which is brown sugar in the amount of ten grams, is inhaled and received every night before going to bed.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences
Full name of responsible person
Masoome Shahnavazi
Street address
Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
Fax
+98 54 3721 0485
Email
mshanavazi1392@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
دکتر فاطمه آذرکیش
Street address
Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Email
Irshums@irshums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr 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
Iranshahr University of Medical Sciences
Full name of responsible person
Masoome Shahnavazi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Email
mshahnavazi1392@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
maryam rigi
Position
Instructor of non-academic staff
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Email
rigimaryam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Masoome Shahnavazi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Email
mshahnavazi1392@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
Some demographic information such as age, sex, marital status, household income, and information about students' sleep disorders will be published in the form of an article without identifying the participants.
When the data will become available and for how long
2022-2023
To whom data/document is available
Researchers in the field of medical sciences
Under which criteria data/document could be used
By referring to the archive of medical science journals
From where data/document is obtainable
By sending an email to the responsible author, Masoome Shahnavazi: mshanavazi1392@gmail.com
What processes are involved for a request to access data/document
By sending an email to the responsible author, Masoome Shahnavazi: mshanavazi1392@gmail.com
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