Determining and comparing the effect of matcha tea and chamomile tea consumption on the severity of primary dysmenorrhea
Design
A one-sided blind clinical trial (by a statistical consultant), with two intervention groups and one control group, which will be conducted on 114 female students who meet the entry criteria. The sampling method will be accessible and the method of assigning samples to groups will be block.
Settings and conduct
The location of the study will be the girls' dormitories of Tehran University. The researcher first has enough information about the research; including the title of the research, objectives, entry criteria, and how to conduct the study will be provided to the students; Then the allocation of samples to groups will be done using block randomization method.
Participants/Inclusion and exclusion criteria
Age 18-40
Absence of pregnancy
Iranian nationality
regular menstrual cycle with a duration of 3-7 days and an interval of 21-35 days between periods
first menstruation before the age of 18
pain during menstruation
Lack of known mental or physical illness according to the person's own statement
Absence of gynecological disease
Not allergic to food, especially green tea or chamomile
Light and moderate bleeding during menstruation
Not using oral contraceptives, benzodiazepines, barbiturates, narcotics, some antidepressants
Not experiencing major stressors in the last two months
Not transferring to another university and graduating within the next five months
Intervention groups
In the intervention group, matcha or chamomile tea will be consumed two days before the cycle until the end of the third day of the menstrual cycle for three months and according to the instructions.
Main outcome variables
Improvement of quantitative, qualitative and accompanying symptoms intensity of primary dysmenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240526061895N1
Registration date:2024-06-05, 1403/03/16
Registration timing:prospective
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Elham Rezaeinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3773 4867
Email address
e-rezaeinia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-08, 1403/03/19
Expected recruitment end date
2024-07-19, 1403/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of matcha tea and chamomile tea consumption on the severity of early dysmenorrhea
Public title
Comparison of the effect of matcha tea and chamomile tea consumption on the severity of early dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being 18-40 years old
Absence of pregnancy
Having Iranian nationality
having a regular menstrual cycle with a duration of 3-7 days and an interval of 21-35 days between periods
Occurrence of first menstruation before the age of 18
having menstrual pain (menstrual pain 5 or more according to the visual pain scale, which indicates moderate and severe dysmenorrhea)
Lack of known mental or physical illness according to the person's own statement
Absence of gynecological disease (myoma, endometriosis, ovarian cyst and pelvic inflammatory disease) according to the person's own statement.
Not allergic to food, especially green tea or chamomile
Light and moderate bleeding during menstruation (absence of clot removal)
Not using oral contraceptives, benzodiazepines, barbiturates, narcotics, some antidepressants such as fluoxetine, anticoagulants, and alcohol.
Not experiencing major stressors such as separation of parents or death of first degree relatives in the last two months
Not transferring to another university and graduating within the next five months
Exclusion criteria:
Unwillingness and consent to participate in the study
Having known chronic mental and physical disorders
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization is for the purpose of making sure that exactly equal number of participants are included in the intervention and control group at consecutive but equal time intervals. Random block method will be used for randomly assigning people to the intervention groups with matcha tea, intervention with chamomile tea and control group (A: intervention with matcha tea, B: intervention with chamomile tea and C: control). Blocking will be done in six blocks (AABBCC, AABCBC, AABCCB, AACBBC, etc.). The randomization unit will be individual. The randomization tool for choosing the block unit will be dice.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the data is entered into the software by the researcher for statistical analysis, and the statistical consultant will perform the analysis without knowing the target group of the sample (intervention with matcha tea, chamomile or control), and in this way, the statistical consultant will be blinded. became.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Joint Ethics Committee of Nursing and Midwifery Faculty and Rehabilitation Faculty of Tehran Univers
Street address
Keshavarz Blvd, Qods St, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2024-05-24, 1403/03/04
Ethics committee reference number
IR.TUMS.FNM.REC.1403.023
Health conditions studied
1
Description of health condition studied
Severity of primary dysmenorrhoea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quantitive pain intensity
Timepoint
The end of the first menstrual day of the cycle before the intervention and the first, second and third cycle after the intervention
Method of measurement
Visual pain scale
2
Description
Qualitative pain intensity
Timepoint
The end of the first menstrual day of the cycle before the intervention and the first, second and third cycle after the intervention
Method of measurement
McGill pain questionnaire
3
Description
Severity of symptoms associated with primary dysmenorrhea
Timepoint
The end of the first menstrual day of the cycle before the intervention and the first, second and third cycle after the intervention
Method of measurement
Andresh Milsom verbal scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group with matcha tea: In this study, the matcha tea product, which is in the form of a powder product, will be used. so that the samples of the intervention group with matcha tea, poured about 500 mg (about half a teaspoon) of matcha powder into a cup of lukewarm water (about 300 cc and about 80 degrees Celsius) and stirred until completely dissolve and white bubbles appear, and from 2 days before the start of the menstrual cycle to the 3rd day of menstruation, they will consume two cups daily (morning and evening) for two cycles. Also, for more certainty, a brochure on how to use the interventions accurately and correctly will be prepared by the researcher and will be provided to the research samples.
Category
Treatment - Other
2
Description
Chamomile tea intervention group: In this study, a powdered product of dried chamomile flowers (prepared from Attari) will be used. In such a way that the samples of the intervention group with chamomile tea dissolved 5000 mg (in the form of 5 gram packets) of chamomile powder in a cup of lukewarm water (about 300 cc) for 3 minutes. Stir it, then pass it through a strainer and consume 2 cups daily (morning and evening) for two cycles from 2 days before the start of menstruation until the 3rd day of menstruation. Also, for more certainty, a brochure on how to use the interventions accurately and correctly will be prepared by the researcher and will be provided to the research samples.
Category
Treatment - Other
3
Description
Control group: During the study, the control group will not receive any intervention from the researcher and will not be allowed to use herbal medicines, but they will be able to take other usual cares that they used to improve dysmenorrhea (massage, heat, walking, taking painkillers). and...), will continue and report its type and amount accurately to the researcher
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Girls' Dormitory Complex, University of Tehran
Full name of responsible person
Dr. Parisa Samadi
Street address
Amirabad, North Krgar St, Tehran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 8801 3701
Fax
+98 21 8801 2024
Email
Kooy@ut.ac.ir
2
Recruitment center
Name of recruitment center
Chamran Girls' Dormitory Complex, University of Tehran
Full name of responsible person
Dr. Parisa Samadi
Street address
Valfajr town, at the end of North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
1439956141
Phone
+98 21 8803 1421 ext. 3
Email
Kooy@ut.ac.ir
3
Recruitment center
Name of recruitment center
Sara student dormitory
Full name of responsible person
Dr Parisa Samadi
Street address
Tehran Province, Tehran, District 2, 5th Nowrouzi St, No. 16
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 2206 2708
Email
Kooy@ut.ac.ir
4
Recruitment center
Name of recruitment center
Dormitory for female doctorate students of Kianour University of Tehran
Full name of responsible person
Dr Parisa Samadi
Street address
No. 1, Sambal Alley, 17th Street, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 8801 3701
Email
Kooy@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
No. 23, Valiasr St., Damascus St., Research Deputy of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3619
Email
gojelou@farabi.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
Dr. Parisa Samadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, No. 1, Dr. Mirkhani St. (East Nusrat), Tawheed Square, Tehran
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4216
Email
pmfsamadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Parisa Samadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, No. 1, Dr. Mirkhani St. (East Nusrat), Tawheed Square, Tehran
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4216
Email
pmfsamadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Parisa Samadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, No. 1, Dr. Mirkhani St. (East Nusrat), Tawheed Square, Tehran
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4216
Email
pmfsamadi@yahoo.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
The information of the participants is reserved and is not in their name.
When the data will become available and for how long
1403
To whom data/document is available
Reputable journals
Under which criteria data/document could be used
Try not to use the documents personally.
From where data/document is obtainable
Universities of Medical Science.
What processes are involved for a request to access data/document