Protocol summary

Study aim
Determining the effect of modifying the pattern of drinking water on the severity of dysmenrrhea, the amount and variety of drugs consumed.
Design
The girls who think that they consume less than 8 glasses of water per day and have early dysmenorrhea, are invited to enter the study. First, the severity of dysmenorrhea in girls will examined by using a visual scale. Individuals who choose at least 3 out of 10, will be selected. Then they will record daily water intake for at least 5 days. If they take less than 8 glasses of water each day, they will be included in the study.
Settings and conduct
This research will be carried out at the Islamic Azad University of Isfahan (Khorasgan). Girls who have primary dysmenorrhea and drink less than 8 glasses of water per day will be included in the study.
Participants/Inclusion and exclusion criteria
History of primary dismenorrhea drinking less than 8 glass per day(each glass contains 250 cc)
Intervention groups
Samples will drink 8 to 10 glass of water every day.
Main outcome variables
Reducing the consumption of pain relieves for dysmenorrhea, promote girls' health, improve their quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180708040377N1
Registration date: 2020-04-16, 1399/01/28
Registration timing: retrospective

Last update: 2020-04-16, 1399/01/28
Update count: 0
Registration date
2020-04-16, 1399/01/28
Registrant information
Name
Behnaz Torkan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4058
Email address
torkan@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-26, 1396/02/06
Expected recruitment end date
2018-04-26, 1397/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of drinking water on the severity of primary dysmenorrhea, amount and variety of drugs consumed and quality of life in female students
Public title
The effect of drinking water on severity of dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Students who have primary dysmenorrhea Students who drink less than 8 glass of water( totally 1600 milliliter)
Exclusion criteria:
History of medical disease like renal, heart, respiratory disease or diabet; Uterine disorders like myoma and endometriosis; Suffering from secondary dysmenorrhea.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
َArghavanieh Bulvard, Postcode: 33998-81551
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Approval date
2016-07-05, 1395/04/15
Ethics committee reference number
IR.MUI.REC.1395.4.076

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhea
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Severity of Primary Dysmenorrhea
Timepoint
One month and two months after modifying the pattern of water drinking
Method of measurement
Questionnaire and Visual Analogue Scale

Secondary outcomes

1

Description
Severity of primary dysmenorrhea, menstrual characteristics and the amount of analgesics used
Timepoint
One month and two months after modifying the pattern of water drinking
Method of measurement
Questionnaire and Visual Anologue Scale for dysmenorrhea

Intervention groups

1

Description
Intervention group: Students who have primary dysmenorrhea and drink less than 8 glasses of water per day will receive water drinking instructions. They will repeat this procedure for two continuous menstrual cycles. During both menstrual bleeding, the severity of dysmenorrhea and intake of analgesics will be investigated.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Isfahan(Khorasgan) Branch, Post code:39998-81551
Full name of responsible person
Behnaz Torkan
Street address
Arghavanieh Bulvard, Post code: 39998-81551
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 4058
Fax
+98 31 3535 4060
Email
torkan@khuisf.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghyani
Street address
Arghavanieh Bulvard, Post code: 39998-81551
City
اصفهان
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
m.toghiani@khuisf.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Behnaz Torkan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Arghavanieh Bulvard, Post code: 39998-81551
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 4058
Email
torkan@khuisf.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnaz Tokran
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Arghavanieh Bulvard, Post code:39998-81551
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 4001
Email
torkan@khuisf.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnaz Torkan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Arghavanieh Bulvard, Post code: 39998-81551
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 4058
Email
torkan@khuisf.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participant's individual data after unidentifiable individuals can be shared
When the data will become available and for how long
Access will start 6 months after the results are printed.
To whom data/document is available
Data will only be available to researchers working at academic and scientific institutions.
Under which criteria data/document could be used
It is allowed to conduct analyzes that lead to the obtaining of relevant research data
From where data/document is obtainable
Please refer to "Behnaz Torkan" at torkan@khuisf.ac.ir for documentation.
What processes are involved for a request to access data/document
It will take a maximum of one month to send the documentation at the request of the applicant.
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