Protocol summary

Study aim
۱۲۴۸/۵۰۰۰The aim of this study was to investigate the effect of orange spring exposure and isometric training on primary dysmenorrhea and sleep quality in non-athlete girls. ارسال بازخورد سابقه ذخیره‌شده‌ها انجمن
Design
۸۷۱/۵۰۰۰ ارسال بازخوردTThe present population is not a type of clinical trial with a control group with parallel groups, blindness is accidental. سابقه ذخیره‌شده‌ها انجمن
Settings and conduct
The statistical population of the study is voluntary female students with primary dysmenorrhea with age range of 18 to 24 years old students residing in Shahrood. The sample size of the study was estimated using the statistical software and the groups were categorized using a random method and a working method questionnaire.
Participants/Inclusion and exclusion criteria
1- Iranians living in Shahrood dormitories 2 - Single 3 - Age 18-24 years old 3- 4- Non-athlete,Conditions of failure 1 - Having pelvic diseases 2 - Irregular menstruation
Intervention groups
۴۱۰/۵۰۰۰ ارسال بازخوردIn this study, we had four groups. The group was submerged under the protocol of the only rainbow of orange spring. A training group that only had isometric exercises according to the practice protocol. The exercises were carried out by both the team and the isometric exercises in accordance with the protocol. The control group did not use any depression or practice. سابقه ذخیره‌شده‌ها انجمن
Main outcome variables
۳۸۲/۵۰۰۰ Demographic information questionnaire, Sleep Inventory, Visual Analogue Scale ارسال بازخورد سابقه ذخیره‌شده‌ها انجمن

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190302042878N1
Registration date: 2021-05-18, 1400/02/28
Registration timing: retrospective

Last update: 2021-05-18, 1400/02/28
Update count: 0
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
Farideh Johariyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4852
Email address
f.joharian70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-23, 1397/12/04
Expected recruitment end date
2019-05-09, 1398/02/19
Actual recruitment start date
2019-02-23, 1397/12/04
Actual recruitment end date
2019-05-09, 1398/02/19
Trial completion date
2019-06-01, 1398/03/11
Scientific title
The effect of iranian spring and isometric exercise on primary dysmenorrhea and sleep quality of non-athletic female students at Shahrood University of Technology;The four groups are: Fluorouracil: Training group: Practice group and Basal group: Control group.
Public title
Effect Review of orange spring notes and isometric training on primary dysmenorrhea and sleep quality of non-athletic female students at Shahrood University of Technology
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of Shahrood dormitories Single Regular menstrual period Non-athlete
Exclusion criteria:
Marriage Irregular chemotherapy Pelvic diseases
Age
From 18 years old to 24 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 88
Actual sample size reached: 80
More than 1 sample in each individual
Actual sample size in each individual: 1
Non-athlete student 2-age from 18 to24
Randomization (investigator's opinion)
Randomized
Randomization description
The type of block accident is 20 volumes; Individual Accident Unit. A randomized envelope accidental tool will be used to hide the random sequence; The closed packets will be used and each random sequence created on a tag will be embedded in the envelopes in order to maintain the sequence; Random numbers were numbered and pasted on the outer part of the envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahrood University of Medical Sciences
Street address
Haft Tir Square, Haft Tir Square, Shahrood University of Technology
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2019-01-31, 1397/11/11
Ethics committee reference number
IR.SHMU.REC.1397.196

Health conditions studied

1

Description of health condition studied
Dysmenorrhea
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fradi, who had a pain intensity of more than 4 at a visual pain scale, were included in the research.
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Visual Analogue Scale: In order to measure pain in subjects, a visual analog scale, or a pain reliever, was used which includes a horizontal line that is scaled from zero to 10, and zero indicates absolute analgesia and 10 signs of unbearable pain. . The degree of pain was measured by the researcher using a visual-linear pain measurement scale that was standardized to measure pain severity. Measured. For this purpose, the person is asked to determine the severity of pain in the area of ​​the affected body by selecting one of the numbers between 1-10, or selecting one of the smears designed (painless, mild pain, moderate pain, severe pain, Most pain possible. The subjects were accordingly divided into 4 groups without primary dysmenorrhea (0). Mild primary dysmenorrhea (1-3). Median Primary Dysmenorrhea( 4-6). And severe

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" only the orphan spring was used, "tarting an intervention from a week before the menstruation until the fifth day of the menstruation for 12 days and the method of use, so that the amount of 10 grams of dried spring orange spring flowers that was special to the north was added to 600 cc of boiling water for 20 minutes. And take two cups a day, and regularly monitor and control the presence of the person on a regular basis and use the infusion for two months and in the menstrual cycle (24 days a day, 2 cups total)
Category
Prevention

2

Description
Intervention group :" only wasometric exercises, " The exercise group performed an isometric exercise program to strengthen the abdominal, pelvic and thigh muscles for 8 weeks.
Category
Prevention

3

Description
Intervention group :" both exercises were isometric and were used in the orange spring.``
Category
Prevention

4

Description
Control group :" no exercises They did not use the orange spring.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Girls' dormitories of Shahroud University of Technology
Full name of responsible person
Farideh Johariyan
Street address
17Th Shahrivar Street
City
Ivan
Province
Ilam
Postal code
6941735119
Phone
+98 84 2323 0359
Email
f.joharian70@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrood University OF Technology
Full name of responsible person
Dr. Ali Dastfan
Street address
Shahrood University OF Technology: Iran - Shahrood - P.O. Box 3619995161 - Phone: +982332392204-9
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Fax
+98 23 3239 5900
Email
hassani_3@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrood University OF Technology
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Ali Hasani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Shahrood University of Technology , 7 Tir square
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
+98 23 3239 5900
Email
hassani-3@yahoo.com
Web page address
https://www.googleshahrood

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Ali Hasani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Shahrood University of Technology , 7 Tir square
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
Hassani_3@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Ali Hasani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Shahrood University of Technology , 7 Tir square
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
+98 23 3239 5900
Email
Hassani_3@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Results Practical protocol
When the data will become available and for how long
2020
To whom data/document is available
Academicians
Under which criteria data/document could be used
Study and refer to it
From where data/document is obtainable
hassani_3@yahoo.com
What processes are involved for a request to access data/document
The request is sent to the email and will be answered
Comments
Loading...