The relationship between date consumption and the severity of dysmenorrhea in women with regular menstruation
Design
One-blind phase 2 clinical trial on 26 participants
Settings and conduct
this study was a clinical trial that was performed on 26 female students of the medical school of Dr. Ali Shariati Hospital in Isfahan. the samples were simulated for the severity of dysmenorrhea and then studied randomly. The subjects were examined for the severity of dysmenorrhea, the amount of pain killer consumed and the amount of menstrual bleeding.simultaneously with the onset of menstrual pain (first 3 days of bleeding), 10 dates were distributed by the researcher among the subjects so that they could take the medicine whenever the subjects needed it. pain intensity and systemic symptoms were evaluated and compared using a multidimensional speech system of the study during 2 consecutive cycles with and without consumption of dates, then the results were analyzed using SPSS 17 software with Wilcoxon paired test.Analyzed. The analyzer did not know the characteristics of the subjects and the relevant cycle.
Participants/Inclusion and exclusion criteria
Inclusion criteria included women with reproductive age range of 22-28 years who have painful and regular menstruation And exclusion criteria included Women who refuse to cooperate during the study, women who have irregular menstrual cycles, women who use hormonal medications such as birth control pills during the menstrual cycle, and the presence of severe stress conditions that affect the results of the study, as well as Women who do not follow the relevant diet were identified.
Intervention groups
The target group was studied in three consecutive cycles and the intervention was applied in the second cycle.
The relationship between date consumption and the severity of dysmenorrhea in women with regular menstrual cycle
Public title
The effect of dates on dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a reproductive age range of 22-28 years who have painful and regular menstruation
Exclusion criteria:
Women who refuse to cooperate during the study, women who have irregular menstrual cycles, women who use hormonal medications such as birth control pills during the menstrual cycle, and the presence of severe stress conditions that affect the results of the study, as well as Women who do not follow the relevant diet
Age
From 22 years old to 28 years old
Gender
Female
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
43
More than 1 sample in each individual
Number of samples in each individual:
3
Each patient was evaluated in three consecutive menstrual cycles.
Actual sample size reached:
26
More than 1 sample in each individual
Actual sample size in each individual:
3
Each patient was evaluated in three consecutive menstrual cycles.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer did not know who the data belonged to and which menstrual cycle it belonged to.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Khomeini Shahr Branch
Street address
Isfahan - Khomeini Shahr - Manzaria - End of Daneshjoo Boulevard - Islamic Azad University Khomeini Shahr Branch
City
Khomeini Shahr
Province
Isfehan
Postal code
۸۴۱۸۱۴۸۴۹۹
Approval date
2022-01-23, 1400/11/03
Ethics committee reference number
طبق نامه شماره 1/3152-13-04 که به پیوست ارسال می گردد.
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Intensity of pain
Timepoint
Monthly for 3 consecutive months
Method of measurement
VAS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 of Bam Mazafati dates in the second cycle of menstruation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital, Isfahan
Full name of responsible person
Dr. Abbas Ali Nasr Isfahani
Street address
Sichan, chahar bagh bala, Taj al-Din alley
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
shariati_isf.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University - Najafabad Branch
Full name of responsible person
Dr. Farid Naimi
Street address
Najafabad - daneshgah Boulevard
City
najaf abad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
info @ iaun.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University - Najafabad Branch
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Izadi Zaman Abadi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ferdowsi St. Manouchehri St. North Mejmar St. Pirooz Building, Second Floor, Unit 6
City
Isfahan
Province
Isfehan
Postal code
8143834438
Phone
+98 31 3272 4538
Email
mimi_izadi2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Atena Khayambashi
Position
Obstetrics and Gynecology Expert
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ferdowsi St. Manouchehri St. North Mejmar St. Pirooz Building, Second Floor, Unit 6
City
Isfahan
Province
Isfehan
Postal code
8143834438
Phone
+98 31 3272 4538
Email
atena_khayambashi2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Izadi Zaman Abadi
Position
Aneshthesiology Expert
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No6. Pirooz Building. North Mejmar Ave. Manoucheri Ave.Ferdoosi Ave
City
Isfahan
Province
Isfehan
Postal code
8143834438
Phone
+98 31 3272 4538
Email
mimi_izadi2@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
All content and study data will be shared after publication.
When the data will become available and for how long
Access will start from the time the article is published.
To whom data/document is available
All authors and managing director of the publication
Under which criteria data/document could be used
To use the contents of this study in dissertations or articles,Students and researchers have access to the documents of this study.
From where data/document is obtainable
Dr Mehdi Izadi Zaman Abadi Address: No6. Pirooz Building. North Mejmar Ave. Manoucheri Ave.Ferdoosi Ave Post Code: 8143834438 E-mail: mimi_izadi2@yahoo.com Tel: 00989131043958
What processes are involved for a request to access data/document
Email or request will be read,and after consulting with other authors, the request will be reviewed and answered.